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Appendix C: Open and Active Clinical Trials on Epithelial Ovarian Cancer
Pages 313-362

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From page 313...
... Furthermore, the committee acknowledges that by limiting the list to studies that specifically target epithelial ovarian cancers, the many more studies being performed on ovarian cancers in general are excluded. A similar search done under the subtopic of ovarian cancer in general revealed 385 open studies and 223 studies that are closed and active but not recruiting.
From page 314...
... 314 OVARIAN CANCERS NCT Number Title Drug Intervention Phase I Interventional Studies NCT01536054 Sirolimus and Vaccine Therapy in Treating Sirolimus Patients With Stage II–IV Ovarian Epithelial, Fallopian Tube, or Primary Peritoneal Cavity Cancer NCT01155258 Temsirolimus and Vinorelbine Ditartrate Temsirolimus; in Treating Patients With Unresectable or vinorelbine ditartrate Metastatic Solid Tumors NCT00357448 Denileukin Diftitox Used in Treating Patients N/A With Advanced Refractory Ovarian Cancer, Primary Peritoneal Carcinoma, or Epithelial Fallopian Tube Cancer NCT01074411 Intraperitoneal Bortezomib and Carboplatin Bortezomib; in Treating Patients With Persistent or carboplatin Recurrent Ovarian Epithelial Cancer, Fallopian Tube Cancer, or Primary Peritoneal Cancer NCT01322802 Vaccine Therapy in Treating Patients With N/A Stage III–IV or Recurrent Ovarian Cancer NCT00436254 Vaccine Therapy With Sargramostim N/A (GM-CSF) in Treating Patients With HER-2 Positive Stage III–IV Breast Cancer or Ovarian Cancer NCT02046421 Carboplatin, Gemcitabine Hydrochloride, Mifepristone; and Mifepristone in Treating Patients With carboplatin; Advanced Breast Cancer or Recurrent or gemcitabine Persistent Ovarian Epithelial, Fallopian hydrochloride Tube, or Primary Peritoneal Cancer NCT00602277 Viral Therapy in Treating Patients With N/A Ovarian Epithelial Cancer, Primary Peritoneal Cancer, or Fallopian Tube Cancer That Did Not Respond to Platinum Chemotherapy NCT01715168 A Crossover Bioequivalence Study of DOXIL/CAELYX; Intravenously Administered ATI-0918 and ATI-0918 DOXIL/CAELYX in Patients With Ovarian Cancer
From page 315...
... 11 University of administration; enzyme- Washington; NCI linked immunosorbent assay; flow cytometry N/A LBA; pharmacological 36 NCI study pUMVC3-hIGFBP-2 LBA 22 University of multi-epitope plasmid Washington; NCI DNA vaccine pNGVL3-hICD vaccine; Flow cytometry; 66 University of sargramostim immunologic technique; Washington; NCI immunoenzyme technique; protein expression analysis; biopsy N/A LBA; pharmacological 22 University of Chicago; study NCI Wild-type reovirus LBA 14 NCI N/A N/A 40 Azaya Therapeutics, Inc.
From page 316...
... ; paclitaxel, mitotic Tube or Peritoneal Cancer inhibitor (intravenous)
From page 317...
... APPENDIX C 317 Estimated Sponsor/ Biological Intervention Other Intervention Enrollment Collaborators N/A N/A 40 TetraLogic Pharmaceuticals Bevacizumab LBA 48 NCI ONT-10, varlilumab N/A 42 Oncothyreon, Inc.; combination Celldex Therapeutics Filgrastim; therapeutic LBA 21 Memorial Sloan autologous Kettering Cancer lymphocytes Center; NCI Carcinoembryonic LBA; reverse 46 Mayo Clinic; NCI antigen-expressing transcriptase-polymerase measles virus; chain oncolytic measles virus encoding thyroidal sodium iodide symporter reaction CART-meso N/A 21 Abramson Cancer Center of the University of Pennsylvania N/A N/A 36 Array BioPharma
From page 318...
... 318 OVARIAN CANCERS NCT Number Title Drug Intervention NCT01121640 A Trial Using Novel Markers to Predict N/A Malignancy in Elevated-Risk Women NCT01286987 Study of BMN 673, a PARP Inhibitor, in BMN 673 Patients With Advanced or Recurrent Solid Tumors NCT01606241 Vaccine Therapy and Cyclophosphamide in Cyclophosphamide Treating Patients With Stage II–III Breast or Stage II–IV Ovarian, Primary Peritoneal, or Fallopian Tube Cancer NCT01522820 Vaccine Therapy With or Without Sirolimus Sirolimus in Treating Patients With NY-ESO-1 Expressing Solid Tumors NCT01264432 Veliparib and Radiation Therapy in Treating Veliparib Patients With Advanced Solid Malignancies With Peritoneal Carcinomatosis, Epithelial Ovarian, Fallopian, or Primary Peritoneal Cancer NCT00892736 Veliparib in Treating Patients With Malignant Veliparib Solid Tumors That Did Not Respond to Previous Therapy NCT00410553 Eribulin Mesylate and Gemcitabine Eribulin mesylate; Hydrochloride in Treating Patients With gemcitabine Metastatic Solid Tumors or Solid Tumors hydrochloride That Cannot be Removed by Surgery NCT01220154 Study of Intraperitoneal Carboplatin With IV Bevacizumab; Paclitaxel and Bevacizumab in Untreated paclitaxel; carboplatin Ovarian Cancer
From page 319...
... APPENDIX C 319 Estimated Sponsor/ Biological Intervention Other Intervention Enrollment Collaborators N/A CA-125 assay on Abbott 1,208 Fred Hutchinson Architect i1000SR Cancer Research platform; HE4 assay Center; The Marsha on Architect i1000SR Rivkin Center for platform; transvaginal Ovarian Cancer ultrasound Research; Canary Foundation; Swedish Medical Center; Beckman Research Institute; Cedars Sinai Medical Center; Stanford University; Fox Chase Cancer Center N/A N/A 113 BioMarin Pharmaceutical Multi-epitope folate LBA 24 Mayo Clinic; NCI receptor alpha peptide vaccine DEC-205/NY-ESO-1 LBA; pharmacological 30 Roswell Park Cancer fusion protein study Institute; NCI CDX-1401 N/A LBA; quality-of-life (QOL) 40 NCI assessment; radiation therapy N/A LBA; pharmacological 120 NCI study N/A N/A 45 NCI N/A N/A 9 David O'Malley; Genentech, Inc.; Ohio State University Comprehensive Cancer Center
From page 320...
... p53MVA Vaccine and Gemcitabine Gemcitabine Hydrochloride in Treating Patients With hydrochloride Recurrent Ovarian Epithelial Cancer NCT01489371* EGEN-001 and Pegylated Liposomal Pegylated liposomal Doxorubicin Hydrochloride in Treating doxorubicin Patients With Recurrent or Persistent hydrochloride Ovarian Epithelial Cancer, Fallopian Tube Cancer, or Primary Peritoneal Cancer NCT01249443*
From page 321...
... APPENDIX C 321 Estimated Sponsor/ Biological Intervention Other Intervention Enrollment Collaborators N/A N/A 19 Boehringer Ingelheim N/A Liquid chromatography; 29 City of Hope Medical mass spectrometry; Center; NCI; National pharmacological study; Comprehensive LBA Cancer Network Filgrastim Autologous hematopoietic 48 Mayo Clinic; NCI stem cell transplantation; peripheral blood stem cell transplantation N/A N/A 103 NCI; National Institutes of Health Clinical Center (CC) N/A Low-dose fractionated 12 University of Miami whole abdominal radiation therapy Modified vaccinia LBA 9 City of Hope Medical virus ankara vaccine Center; NCI expressing p53 EGEN-001 LBA 18 Gynecologic Oncology Group; NCI N/A Diagnostic LBA; 26 AIDS Malignancy pharmacological study Consortium; NCI; The EMMES Corporation N/A N/A 145 ImmunoGen, Inc.
From page 322...
... p53MVA Vaccine and Gemcitabine Gemcitabine Hydrochloride in Treating Patients With hydrochloride Recurrent Ovarian Epithelial Cancer NCT01489371* EGEN-001 and Pegylated Liposomal Pegylated liposomal Doxorubicin Hydrochloride in Treating doxorubicin Patients With Recurrent or Persistent hydrochloride Ovarian Epithelial Cancer, Fallopian Tube Cancer, or Primary Peritoneal Cancer NCT01249443*
From page 323...
... N/A N/A 48 Dr. Reddy's Laboratories Limited N/A N/A 40 Corcept Therapeutics N/A LBA 180 Barbara Ann Karmanos Cancer Institute; NCI N/A 24 Fox Chase Cancer Center GEN-1 N/A 15 Celsion N/A Omega Nutrition cold- 90 Southern Illinois milled flaxseeds University N/A N/A 20 University Medical Center Groningen
From page 324...
... Veliparib and Pegylated Liposomal Pegylated liposomal Doxorubicin Hydrochloride in Treating doxorubicin Patients With Recurrent Ovarian Cancer, hydrochloride; veliparib Fallopian Tube Cancer, or Primary Peritoneal Cancer or Metastatic Breast Cancer NCT02344095* A Trial of Weekly Paclitaxel With Weekly paclitaxel; Oncothermia and Weekly Cisplatin With weekly cisplatin Oncothermia in Patients With Recurrent or Persistent Ovarian Cancer NCT00989651*
From page 325...
... APPENDIX C 325 Estimated Sponsor/ Biological Intervention Other Intervention Enrollment Collaborators Prolanta, a human N/A 18 Oncolix, Inc. prolactin receptor antagonist Aldesleukin; HER2Bi- LBA 20 Barbara Ann armed activated T Karmanos Cancer cells; sargramostim Institute; NCI Modified vaccinia LBA 12 City of Hope Medical virus ankara vaccine Center; NCI expressing p53; pembrolizumab Pembrolizumab; LBA 36 NCI ziv-aflibercept Bevacizumab LBA; pharmacological 60 NCI study N/A LBA; pharmacological 58 NCI study N/A Oncothermia 12 Seoul National University Hospital Bevacizumab LBA 474 NCI N/A N/A 30 University of California, Irvine N/A N/A 89 Polaris Group N/A N/A 10 University of Pennsylvania
From page 326...
... Mesenchymal Stem Cells (MSC) for Ovarian N/A Cancer Phase I/II Interventional Studies NCT00553683 Cyclophosphamide, Radiation Therapy, Cyclophosphamide; and Poly ICLC in Treating Patients With poly ICLC Unresectable, Recurrent, Primary, or Metastatic Liver Cancer NCT01472783 Veliparib Monotherapy for Relapsed Veliparib Ovarian Cancer With BRCA Mutation NCT01091428 MLN8237 in Patients With Ovarian, MLN8237 + paclitaxel Fallopian Tube or Peritoneal Cancer Preceded by Phase 1 Study of MLN8237 Plus Paclitaxel Treatment of Ovary or Breast Cancer NCT01238770 Phase I/II Study of Pazopanib and Pazopanib Cyclophosphamide in Patients With Platinum-Resistant Recurrent Ovarian Cancer NCT00317772 Topotecan and Gefitinib (Iressa)
From page 327...
... med. Joachim Rom; University Hospital Heidelberg N/A N/A 52 MD Anderson Cancer Center; AstraZeneca; GlaxoSmithKline N/A NovoTTF-100L(O)
From page 328...
... Paclitaxel and Ganetespib in Treating Paclitaxel; ganetespib Patients With Recurrent Ovarian, Fallopian Tube, or Primary Peritoneal Cancer NCT02068794* MV-NIS Infected Mesenchymal Stem Cells N/A in Treating Patients With Recurrent Ovarian Cancer NCT01402271*
From page 329...
... N/A N/A 48 Advenchen Laboratories, LLC N/A N/A 190 Celldex Therapeutics; Bristol-Myers Squibb DEC-205/NY-ESO-1 LBA; pharmacological 98 Roswell Park Cancer fusion protein study Institute; NCI; Celldex CDX-1401 Therapeutics N/A N/A 222 Medical University Innsbruck; European Commission N/A N/A 116 Eli Lilly and Company N/A LBA; pharmacological 162 NCI study Enadenotucirev N/A 35 PsiOxus Therapeutics, Ltd
From page 330...
... p53 Suppressor Activation in Recurrent APR-246; carboplatin; High-Grade Serous Ovarian Cancer, a pegylated liposomal Phase Ib/II Study of Systemic Carboplatin doxorubicin Combination Chemotherapy With or hydrochloride Without APR-246 Phase II Interventional Studies NCT02107950 Phase II Study DCVAC/OvCa Plus Standard of care Carboplatin Gemcitabine Relapsed chemotherapy Platinum (Pt) -Sensitive Epithelial Ovarian Carcinoma NCT01039207 Rilotumumab in Treating Patients With N/A Persistent or Recurrent Ovarian Epithelial Cancer, Fallopian Tube Cancer, or Primary Peritoneal Cancer NCT02107378 Efficacy of DCVAC/OvCa Plus Standard Standard of care of Care in Relapsed Platinum Resistant (paclitaxel or topotecan Epithelial Ovarian Carcinoma or doxorubicin)
From page 331...
... EGEN-001 LBA 56 Gynecologic Oncology Group; NCI N/A N/A 112 AstraZeneca; British Columbia Cancer Agency N/A QOL assessment 275 NCIC Clinical Trials Group; NCI; Grupo Español de Investigación en Cáncer de Ovario; Cancer Research UK; Southwest Oncology Group N/A LBA 53 NCI
From page 332...
... ; Recurrent or Persistent Epithelial Ovarian, VTX-2337 Fallopian Tube or Primary Peritoneal Cancer NCT00511992 Study of Bevacizumab Followed by Avastin Bevacizumab Consolidation for Ovarian Cancer NCT00872989 S0904: Docetaxel With or Without Docetaxel; vandetanib Vandetanib in Treating Patients With Persistent or Recurrent Ovarian Epithelial Cancer, Fallopian Tube Cancer, or Primary Peritoneal Cancer NCT01097746 First-line Treatment of Weekly Paclitaxel Carboplatin; paclitaxel; With Carboplatin and Bevacizumab in bevacizumab Ovarian Cancer NCT01720173 Dalantercept in Treating Patients With N/A Recurrent Ovarian Epithelial, Fallopian Tube, or Primary Peritoneal Cavity Cancer NCT01716715 Cabozantinib or Paclitaxel in Treating Cabozantinib S-malate; Patients With Persistent or Recurrent paclitaxel Epithelial Ovarian, Fallopian Tube, or Primary Peritoneal Cavity Cancer NCT01540565 Veliparib in Treating Patients With Persistent Veliparib or Recurrent Epithelial Ovarian, Fallopian Tube, or Primary Peritoneal Cancer NCT01468909 Paclitaxel With or Without Pazopanib Paclitaxel; pazopanib Hydrochloride in Treating Patients With hydrochloride Persistent or Recurrent Ovarian Epithelial, Fallopian Tube, or Peritoneal Cavity Cancer
From page 333...
... APPENDIX C 333 Estimated Sponsor/ Biological Intervention Other Intervention Enrollment Collaborators N/A N/A 27 City of Hope Medical Center N/A LBA 74 NCI N/A LBA 20 Mayo Clinic; NCI N/A N/A 290 VentiRx Pharmaceuticals Inc.; Gynecologic Oncology Group N/A N/A 22 University of Oklahoma; Genentech, Inc. N/A N/A 120 Southwest Oncology Group; NCI N/A N/A 30 MD Anderson Cancer Center; Genentech, Inc.
From page 334...
... 334 OVARIAN CANCERS NCT Number Title Drug Intervention NCT01305213 Bevacizumab With or Without Fosbretabulin Fosbretabulin Tromethamine in Treating Patients With tromethamine Recurrent or Persistent Ovarian Epithelial, Fallopian Tube, or Peritoneal Cavity Cancer NCT01199263 Paclitaxel With or Without Viral Therapy Paclitaxel in Treating Patients With Recurrent or Persistent Ovarian Epithelial, Fallopian Tube, or Primary Peritoneal Cancer NCT01010126 Temsirolimus and Bevacizumab in Treating Temsirolimus Patients With Advanced Endometrial, Ovarian, Liver, Carcinoid, or Islet Cell Cancer NCT02324595 Minimally Invasive Interval Debulking N/A Surgery in Ovarian Neoplasm: A Feasibility Study NCT01991210 A Randomized Study of DNIB0600A in DNIB0600A; pegylated Comparison With Pegylated Liposomal liposomal doxorubicin Doxorubicin in Patients With Platinum Resistant Ovarian Cancer NCT00857545 OPT-821 With or Without Vaccine N/A Therapy in Treating Patients With Ovarian Epithelial Cancer, Fallopian Tube Cancer, or Peritoneal Cancer in Second or Third Complete Remission NCT00744718 Bevacizumab and Carboplatin for Patients Bevacizumab; With Ovarian Cancer carboplatin NCT00551070 Selumetinib in Treating Woman With Selumetinib Recurrent Low-Grade Ovarian Cancer or Peritoneum Cancer NCT01460979 Activity, Tolerability, Safety of Temsirolimus Temsirolimus in Women With Ovarian Cancer Who Progressed During Previous Platinum Chemotherapy or Within 6 Months After Therapy or Advanced Endometrial Carcinoma NCT00373217 Vaccine Therapy, Paclitaxel, and Carboplatin; paclitaxel Carboplatin in Treating Patients Who Are Undergoing Surgery for Stage III or Stage IV Ovarian Cancer, Primary Peritoneal Cancer, or Fallopian Tube Cancer
From page 335...
... APPENDIX C 335 Estimated Sponsor/ Biological Intervention Other Intervention Enrollment Collaborators Bevacizumab LBA 110 NCI Wild-type reovirus LBA 110 NCI Bevacizumab N/A 299 NCI N/A Laparoscopic interval 30 Catholic University debulking surgery of the Sacred Heart; Fagotti, Anna, M.D.; Francesco Fanfani; Salvatore Gueli Alletti N/A N/A 95 Genentech, Inc. Immunoadjuvant LBA 164 Gynecologic OPT-821; polyvalent Oncology Group; NCI antigen-KLH conjugate vaccine N/A N/A 30 Vejle Hospital N/A LBA; pharmacological 52 NCI study N/A N/A 86 AGO Study Group MAGE-A1, Her-2/neu, Conventional surgery 28 Craig L Slingluff, Jr.; FBP peptides ovarian NCI; University of cancer vaccine; Virginia tetanus toxoid helper peptide
From page 336...
... Metformin Hydrochloride and Combination Paclitaxel; carboplatin; Chemotherapy in Treating Patients With docetaxel; metformin Stage III–IV Ovarian, Fallopian Tube, or hydrochloride Primary Peritoneal Cancer NCT00888615* Elesclomol Sodium and Paclitaxel in Elesclomol sodium; Treating Patients With Recurrent or paclitaxel Persistent Ovarian Epithelial Cancer, Fallopian Tube Cancer, or Primary Peritoneal Cancer NCT02584465*
From page 337...
... N/A Behavioral, psychological, 100 Ohio State University or informational Comprehensive intervention Cancer Center; NCI N/A LBA 160 University of Chicago; NCI N/A N/A 55 Gynecologic Oncology Group; NCI N/A N/A 116 ARCAGY/GINECO GROUP; Bayer N/A HIPEC 10 Krankenhaus Barmherzige Schwestern Linz N/A N/A 210 Glycotope GmbH Ovapuldencel-T; MC: N/A 99 Caladrius autologous PBMCs in Biosciences, Inc. GM-CSF Cytokine-induced killer Radiofrequency ablation 50 The First People's cells Hospital of Changzhou
From page 338...
... MV-NIS or Investigator's Choice Pegylated liposomal Chemotherapy in Treating Patients With doxorubicin Ovarian, Fallopian, or Peritoneal Cancer hydrochloride; gemcitabine hydrochloride; topotecan hydrochloride; paclitaxel NCT02101775* Gemcitabine Hydrochloride With or Without Gemcitabine WEE1 Inhibitor MK-1775 in Treating hydrochloride; WEE1 Patients With Recurrent Ovarian, Primary inhibitor AZD1775 Peritoneal, or Fallopian Tube Cancer NCT02125513*
From page 339...
... APPENDIX C 339 Estimated Sponsor/ Biological Intervention Other Intervention Enrollment Collaborators N/A N/A 30 Gynecologic Oncology Associates; University of North Carolina at Chapel Hill N/A N/A 74 Mario Negri Institute for Pharmacological Research; PharmaMar; Hoffmann-La Roche N/A LBA 34 NCI N/A N/A 48 Thomas Jefferson University; NIH N/A Cytoreductive surgery; 48 Mercy Medical Center questionnaire; HIPEC Oncolytic measles LBA; QOL assessment 134 Mayo Clinic; NCI virus encoding thyroidal sodium iodide symporter N/A LBA; pharmacological 100 NCI study N/A Surgery 220 Azienda Ospedaliera Universitaria di Bologna Policlinico S Orsola Malpighi N/A N/A 105 Karyopharm Therapeutics, Inc.
From page 340...
... Avatar-Directed Chemotherapy in Treating Gemcitabine Patients With Ovarian, Primary Peritoneal, hydrochloride; or Fallopian Tube Cancer paclitaxel; pegylated liposomal doxorubicin hydrochloride; topotecan hydrochloride NCT02059265* Dasatinib in Treating Patients With Dasatinib Recurrent or Persistent Ovarian, Fallopian Tube, Endometrial, or Peritoneal Cancer NCT01853644*
From page 341...
... APPENDIX C 341 Estimated Sponsor/ Biological Intervention Other Intervention Enrollment Collaborators N/A N/A 88 Western Regional Medical Center N/A Total or subtotal 80 Shanghai Gynecologic colectomy; other bowel Oncology Group; resection Shanghai Zhongshan Hospital N/A N/A 480 Clovis Oncology, Inc.; Foundation Medicine N/A N/A 30 Jonsson Comprehensive Cancer Center N/A LBA 70 NCI N/A LBA; pharmacological 70 NCI study N/A N/A 60 Mayo Clinic; NCI N/A LBA 62 NCI N/A N/A 30 Northwestern University; National Comprehensive Cancer Network
From page 342...
... The Efficacy of Involved-field Radiation N/A Therapy for Residual or Locoregionally Recurrent Epithelial Ovarian Cancer After Definitive Treatment; Multi-institutional Clinical Trial NCT02435186* p53 Gene in Treatment of Recurrent p53 gene; cisplatin; Ovarian Epithelial Cancer, Fallopian Tube paclitaxel Cancer, and Primary Peritoneal Cancer NCT02487849*
From page 343...
... GM-CSF N/A N/A 247 ImmunoGen, Inc. Cytokine-induced killer Radiofrequency ablation 50 The First People's cells Hospital of Changzhou N/A LBA; pharmacological 117 NCI study N/A LBA 70 NCI
From page 344...
... Cediranib Maleate and Olaparib or Cediranib maleate; Standard Chemotherapy in Treating olaparib; paclitaxel; Patients With Recurrent Platinum-Resistant pegylated liposomal or -Refractory Ovarian, Fallopian Tube, or doxorubicin Primary Peritoneal Cancer hydrochloride; topotecan hydrochloride NCT01506856* Intraperitoneal Therapy for Ovarian Cancer IV paclitaxel + IV With Carboplatin Trial carboplatin; IV paclitaxel + IP carboplatin Phase III Interventional Studies NCT00951496 Bevacizumab and Intravenous or Carboplatin; cisplatin; Intraperitoneal Chemotherapy in Treating paclitaxel Patients With Stage II–III Ovarian Epithelial Cancer, Fallopian Tube Cancer, or Primary Peritoneal Cancer NCT01167712 Paclitaxel and Carboplatin With or Without Carboplatin; paclitaxel Bevacizumab in Treating Patients With Stage II, Stage III, or Stage IV Ovarian Epithelial Cancer, Primary Peritoneal Cancer, or Fallopian Tube Cancer NCT01081262 Carboplatin and Paclitaxel or Oxaliplatin Capecitabine; and Capecitabine With or Without carboplatin; oxaliplatin; Bevacizumab as First-Line Therapy in paclitaxel Treating Patients With Newly Diagnosed Stage II–IV or Recurrent Stage I Epithelial Ovarian or Fallopian Tube Cancer NCT00954174 Paclitaxel and Carboplatin or Ifosfamide Paclitaxel; carboplatin; in Treating Patients With Newly Diagnosed ifosfamide Persistent or Recurrent Uterine, Ovarian, Fallopian Tube, or Peritoneal Cavity Cancer
From page 345...
... APPENDIX C 345 Estimated Sponsor/ Biological Intervention Other Intervention Enrollment Collaborators N/A LBA; pharmacological 250 NCI study; QOL assessment N/A LBA; questionnaire 680 NCI administration N/A N/A 654 Gynecologic Oncology Trial & Investigation Consortium; Japanese Gynecologic Oncology Group Bevacizumab LBA; QOL assessment 1500 NCI Bevacizumab Computed tomography; 650 NCI therapeutic conventional surgery Bevacizumab LBA; QOL assessment 332 NCI N/A QOL assessment 603 Gynecologic Oncology Group; NCI
From page 346...
... NCT00719303* Diet and Physical Activity Change or Usual N/A Care in Improving Progression-Free Survival in Patients With Previously Treated Stage II, III, or IV Ovarian, Fallopian Tube, or Primary Peritoneal Cancer
From page 347...
... video N/A N/A 208 Hoffmann-La Roche N/A N/A 464 Alliance for Clinical Trials in Oncology; NCI; Mayo Clinic Bevacizumab N/A 682 AGO Research GmbH; Arbeitsgemeinschaft Gynaekologische Onkologie Austria; ARCAGY/ GINECO GROUP; ANZGOG; Scottish Gynaecological Cancer Study Group Bevacizumab Specialized pathology 800 AGO Study review E182 (Germany Group; ARCAGY/ only) GINECO GROUP; Nordic Society for Gynaecologic Oncology N/A N/A 223 Amgen N/A Behavioral dietary 1,070 Gynecologic intervention; compliance Oncology Group; NCI monitoring; counseling; educational intervention; exercise intervention; LBA; QOL assessment; questionnaire administration
From page 348...
... and DOXIL/ dexamethasone CAELYX With DOXIL/CAELYX for the Treatment of Advanced-Relapsed Epithelial Ovarian, Primary Peritoneal, or Fallopian Tube Cancer NCT00565851* Carboplatin, Paclitaxel, and Gemcitabine Carboplatin; Hydrochloride With or Without docetaxel; gemcitabine Bevacizumab After Surgery in Treating hydrochloride; Patients With Recurrent Ovarian Epithelial paclitaxel Cancer, Primary Peritoneal Cavity Cancer, or Fallopian Tube Cancer NCT01611766*
From page 349...
... , former Nerviano Medical Sciences; Onlus Cancro Primo Aiuto N/A Secondary debulking 280 The Netherlands with or without IP Cancer Institute chemotherapy N/A N/A 400 National Cancer Institute, Naples; Mario Negri Institute for Pharmacological Research N/A N/A 1,485 Medical Research Council; Cancer Research UK N/A N/A 670 Janssen Research & Development, LLC; PharmaMar Bevacizumab LBA; QOL assessment 1,038 NCI N/A Secondary cytoreductive 420 Shanghai Gynecologic surgery Oncology Group; Fudan University; Zhejiang Cancer Hospital; Shanghai Zhongshan Hospital; Sun Yat-sen University N/A Maximal cytoreductive 444 UNICANCER surgery
From page 350...
... NCT01747798 Auranofin in Treating Patients With Auranofin Recurrent Epithelial Ovarian, Primary Peritoneal, or Fallopian Tube Cancer NCT02096783 Scripted Sexual Health Informational N/A Intervention in Improving Sexual Function in Patients With Gynecologic Cancer NCT01696994 Screening for Ovarian Cancer in Older N/A Patients (PLCO Screening Trial) NCT02595281 HE4 as a Relapse Biomarker in Ovarian N/A Cancers NCT00946283 Lactobacillus in Preventing Infection in N/A Patients Undergoing a Donor Stem Cell Transplant for Hematologic Cancer or Myelodysplastic Syndrome NCT02578888*
From page 351...
... APPENDIX C 351 Estimated Sponsor/ Biological Intervention Other Intervention Enrollment Collaborators N/A LBA; QOL assessment 450 NCI N/A N/A 400 National Cancer Institute, Naples; Mario Negri Institute for Pharmacological Research N/A LBA 10 Mayo Clinic N/A Informational intervention; 30 University of counseling intervention; Wisconsin–Madison; questionnaire NCI administration N/A Ultrasound imaging; 78,216 NCI screening questionnaire administration; LBA N/A Experimental arm 90 Institut de Cancérologie de Lorraine N/A Lactobacillus rhamnosus 30 Rutgers, The State GG (dietary supplement) University of New Jersey; NCI; Rutgers Cancer Institute of New Jersey N/A Palliative therapy; 180 Albert Einstein palliative therapy + College of Medicine idiographic of Yeshiva University; NCI N/A Correlative studies 35 William Carson; Ohio State University Comprehensive Cancer Center N/A Acute normovolemic 41 Memorial Sloan hemodilution Kettering Cancer Center
From page 352...
... Feasibility Study: Therapeutic Targeting of Propranolol; Stress Factors in Ovarian Cancer Patients chemotherapy NCT02530606* Photoacoustic Imaging in Detecting Ovarian N/A or Fallopian Tube Cancer NCT02110277*
From page 353...
... Elisabeth Hospital, Tilburg, Netherlands; Catharina Ziekenhuis Eindhoven; Radboud University; Jeroen Bosch Ziekenhuis N/A Surgery; questionnaire 25 MD Anderson Cancer Center; Sprint for Life N/A Photoacoustic imaging 20 Stanford University; NCI N/A Photoacoustic imaging/ 40 University of ultrasound diagnostic Connecticut Health group (device) Center; NCI
From page 354...
... Lavage of the Uterine Cavity for the N/A Diagnosis of Ovarian and Tubal Carcinoma and Their Premalignant Changes Observational Studies NCT01276574 Epithelial Ovarian Cancer–Staging and Not indicated Response to Chemotherapy Evaluated by PET/CT NCT00899093 Tumor Marker YKL-40 in Patients With N/A Newly Diagnosed Stage III or Stage IV Ovarian Epithelial Cancer, Primary Peritoneal Cavity Cancer, or Fallopian Tube Cancer Undergoing Chemotherapy
From page 355...
... APPENDIX C 355 Estimated Sponsor/ Biological Intervention Other Intervention Enrollment Collaborators N/A Educational intervention; 200 City of Hope Medical telephone-based Center; NCI; American intervention; QOL Cancer Society assessment; questionnaire National Office administration N/A Follow-up care; active 20 City of Hope Medical surveillance; questionnaire Center; NCI administration N/A Gynecological 120 Centre Francois consultation Baclesse; Ligue contre le cancer, France; Fondation de France Multi-epitope folate LBA 22 Mayo Clinic; NCI receptor alpha-loaded dendritic cell vaccine N/A Lavage of the cavum uteri 200 Medical University of and proximal fallopian Vienna tubes N/A Surgery for EOC with trial 150 Thumuluru Kavitha (PJ) device (PlasmaJet)
From page 356...
... Prospective Identification and Validation of Not indicated "BRCANess" Profile in Ovarian Epithelial Cancer NCT00488878* Data Collection for Patients With Low- N/A Grade Ovarian Carcinoma NCT01907789*
From page 357...
... APPENDIX C 357 Estimated Sponsor/ Biological Intervention Other Intervention Enrollment Collaborators N/A Cognitive assessment; 256 Gynecologic QOL assessment Oncology Group; NCI N/A Gene expression 39 Gynecologic analysis; protein Oncology Group; NCI analysis; flow cytometry; immunoenzyme technique; immunohistochemistry staining method; LBA N/A Yoga therapy 106 Comprehensive Cancer Center of Wake Forest University; NCI N/A Flow cytometry; LBA; data 200 Vanderbilt-Ingram collection Cancer Center; NCI; NIH N/A Immunological diagnostic 48 Comprehensive method; physiologic Cancer Center testing of Wake Forest University; NCI Not Indicated Not indicated 40 Rennes University Hospital Not Indicated Not indicated 230 Fundación de investigación HM; AstraZeneca N/A Data collection 2,000 MD Anderson Cancer Center N/A Ovarian cancer 80 MD Anderson Cancer screening; prophylactic Center salpingectomy with delayed oophorectomy; risk-reducing salpingo oophorectomy; questionnaire; transvaginal ultrasound; phone call N/A LBA 174 Gynecologic Oncology Group; NCI
From page 358...
... An Observational Study of Avastin Not indicated (Bevacizumab) in Patients With Advanced/ Metastatic Epithelial Ovarian Cancer, Fallopian Tube Cancer, or Primary Peritoneal Cancer NCT02408536*
From page 359...
... APPENDIX C 359 Estimated Sponsor/ Biological Intervention Other Intervention Enrollment Collaborators Not indicated Not indicated 700 University of California, Davis; NCI N/A Comprehensive geriatric 228 NRG Oncology; NCI assessment; questionnaire administration N/A N/A 500 ARCAGY/ GINECO GROUP; Roche Pharma AG N/A N/A 80 Grupo Español de Investigación en Cáncer de Ovario; PharmaMar N/A Evaluation of cancer 2,605 Gynecologic risk factors; medical Oncology Group; NCI chart review; study of socioeconomic and demographic variables N/A Observational study 200 Oslo University Hospital; The Research Council of Norway Not indicated Not indicated 100 University Health Network, Toronto Not indicated Not indicated 30 Charite University, Berlin, Germany Not indicated Not indicated 100 Hoffmann-La Roche Not indicated Not indicated 150 National Cancer Institute, Naples Not indicated Not indicated 25 Claudia Spies; Charite University, Berlin, Germany
From page 360...
... Specimen and Data Study for Ovarian N/A Cancer Early Detection and Prevention NCT02524808* Prospective Identification and Validation of Not indicated "BRCANess" Profile in Ovarian Epithelial Cancer NCT02489058*
From page 361...
... APPENDIX C 361 Estimated Sponsor/ Biological Intervention Other Intervention Enrollment Collaborators Not indicated Not indicated 200 Hellenic Oncology Research Group N/A LBA; screening 6000 Northwestern questionnaire University; NCI administration; study of high-risk factors Not indicated Not indicated 230 Fundación de investigación HM; AstraZeneca Not indicated Not indicated 100 University Health Network, Toronto Not indicated Not indicated 25 Claudia Spies; Charite University, Berlin, Germany


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