Trial of Pemetrexed and Bevacizumab for Recurrent Ovarian Primary Peritoneal Carcinoma
NCT ID: NCT00868192
Last Updated: 2014-10-20
Study Results
Results available
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
Recruitment Status
COMPLETED
Clinical Phase
PHASE2
Total Enrollment
38 participants
Study Classification
INTERVENTIONAL
Study Start Date
2008-05-31
Study Completion Date
2012-12-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
The purpose of this study is to determine if the combination of bevacizumab and pemetrexed have an effect on recurrent ovarian and primary peritoneal carcinoma by looking at progression and survival at 6 months.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Carboplatin and Paclitaxel With or Without Bevacizumab Compared to Docetaxel, Carboplatin, and Paclitaxel in Treating Patients With Stage II, Stage III, or Stage IV Ovarian Epithelial, Fallopian Tube, or Primary Peritoneal Cavity Carcinoma (Cancer)
NCT00085358
Brenner Tumor
Fallopian Tube Cancer
Ovarian Carcinosarcoma
+10 more
COMPLETED
PHASE1
Bevacizumab and Anetumab Ravtansine or Paclitaxel in Treating Patients With Refractory Ovarian, Fallopian Tube, or Primary Peritoneal Cancer
NCT03587311
Fallopian Tube Endometrioid Adenocarcinoma
Fallopian Tube High Grade Serous Adenocarcinoma
Ovarian Endometrioid Adenocarcinoma
+5 more
ACTIVE_NOT_RECRUITING
PHASE2
Carboplatin and Pemetrexed in Recurrent Platinum Sensitive Ovarian Cancer
NCT00230542
Ovarian Cancer
Peritoneal Cancer
Fallopian Tube Cancer
COMPLETED
PHASE2
Bevacizumab and Low-Dose Cyclophosphamide in Treating Patients With Recurrent Ovarian Epithelial or Primary Peritoneal Cancer
NCT00072566
Primary Peritoneal Carcinoma
Recurrent Ovarian Carcinoma
Stage IV Ovarian Cancer
COMPLETED
PHASE2
Bevacizumab With Abraxane in Patients With Recurrent Ovarian/ Peritoneal Cancer
NCT00407563
Epithelial Ovarian Cancer
Primary Peritoneal Carcinoma
COMPLETED
PHASE2
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Patients will be treated with pemetrexed 500 mg/m2 IV and Bevacizumab 15 mg/kg IV every 3 weeks.The patient is treated indefinitely until side effects are deemed severe by the investigator or until progression. Disease progression is measured every 6 weeks using RECIST criteria.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Ovarian Carcinoma
Primary Peritoneal Carcinoma
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
Allocation Method
NA
Intervention Model
SINGLE_GROUP
Primary Study Purpose
TREATMENT
Blinding Strategy
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Pemetrexed and bevacizumab
Pemetrexed 500 mg/m2 IV on Day 1 of each 21 day cycle
Bevacizumab 15 mg/kg IV on Day 1 of each 21 day cycle
Group Type
EXPERIMENTAL
Pemetrexed
Intervention Type
DRUG
Bevacizumab
Intervention Type
DRUG
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Pemetrexed
Intervention Type
DRUG
Bevacizumab
Intervention Type
DRUG
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Alimta
Avastin
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Recurrent epithelial ovarian or primary peritoneal carcinoma. Histologic confirmation of the primary tumor is required. Patients with borderline tumors are not eligible.
* Patients must have measurable disease. Measurable disease is defined as at least one lesion that can be accurately measured in one dimension (longest dimension to be recorded). Each lesion must by \> 20 mm when measured by conventional imaging techniques, including plain radiography, computed tomography and MRI or \> 10 mm when measured by spiral CT.
* Patients must have at least one "target lesion" to assess response by RECIST criteria. Lesions within a previously irradiated field will be considered "non-target" lesions.
* Patients must have a GOG performance status of 0 or 1.
* Patients must have the ability to interrupt non-steroidal anti-inflammatory (NSAID) treatment 2 days before (5 days for long-acting NSAIDs), the day of, and 2 days following administration of pemetrexed.
* Patients must have the ability to take folic acid, vitamin B12 and dexamethasone as described per protocol.
* Recovery from effects of recent surgery, radiotherapy or chemotherapy.
* Patients should be free of active infection requiring antibiotics.
* Any hormonal therapy directed at the tumor must be discontinued at least one week prior to registration. Continuation of hormone replacement therapy (HRT) is permitted.
* Any other prior therapy directed at the malignant tumor, including immunologic agents and cytotoxic agents, must be discontinued at least three weeks prior to registration.
* Patients must have had one prior platinum-based chemotherapeutic regimen for management of primary disease containing carboplatin, cisplatin, or another organoplatinum compound. This initial treatment may have included high-dose therapy, consolidation, or extended therapy administered after surgical or non-surgical assessment.
* Patients must have had one prior regimen containing a taxane compound. Patient may have received first-line treatment either intravenously or intraperitoneally.
* Patients must NOT have received prior therapy with pemetrexed or bevacizumab.
* Patients may have received a total of \< 2 prior cytotoxic chemotherapy regimens (adjuvant therapy plus one additional regimen). Consolidation or extended therapy as part of first line treatment will be considered as a single regimen.
* Bone marrow function: absolute neutrophil count (ANC) greater than or equal to 1,500/ul, equivalent to Common Toxicity Criteria (CTC) grade 1; Platelets greater than or equal to 100,000/ul.
* Creatinine clearance must be greater than 45 ml/min.
* Hepatic function: bilirubin less than or equal to 1.5 x ULN. AST and alkaline phosphatase less than or equal to 2.5 x ULN.
* Neurologic function: neuropathy (sensory and motor) less than or equal to CTC grade 1.
* Coagulation: prothrombin time (PT) such that the international normalized ratio (INR) is \< 1.5 (INR may be between 2 and 3 if a patient is on stable dose of therapeutic warfarin) and a PTT \< 1.2 times control.
* Patients must have signed informed consent.
* Patients must meet pre-entry requirements.
* Patients of childbearing potential must have a negative serum pregnancy test prior to study entry, be practicing an effective form of contraception, and cannot be lactating.
* Patients may have received prior radiotherapy (to less than 25% of bone marrow), but must start at a Level 1 dose reduction.
* Patients must have measurable disease. Measurable disease is defined as at least one lesion that can be accurately measured in one dimension (longest dimension to be recorded). Each lesion must by \> 20 mm when measured by conventional imaging techniques, including plain radiography, computed tomography and MRI or \> 10 mm when measured by spiral CT.
* Patients must have at least one "target lesion" to assess response by RECIST criteria. Lesions within a previously irradiated field will be considered "non-target" lesions.
* Patients must have a GOG performance status of 0 or 1.
* Patients must have the ability to interrupt non-steroidal anti-inflammatory (NSAID) treatment 2 days before (5 days for long-acting NSAIDs), the day of, and 2 days following administration of pemetrexed.
* Patients must have the ability to take folic acid, vitamin B12 and dexamethasone as described per protocol.
* Recovery from effects of recent surgery, radiotherapy or chemotherapy.
* Patients should be free of active infection requiring antibiotics.
* Any hormonal therapy directed at the tumor must be discontinued at least one week prior to registration. Continuation of hormone replacement therapy (HRT) is permitted.
* Any other prior therapy directed at the malignant tumor, including immunologic agents and cytotoxic agents, must be discontinued at least three weeks prior to registration.
* Patients must have had one prior platinum-based chemotherapeutic regimen for management of primary disease containing carboplatin, cisplatin, or another organoplatinum compound. This initial treatment may have included high-dose therapy, consolidation, or extended therapy administered after surgical or non-surgical assessment.
* Patients must have had one prior regimen containing a taxane compound. Patient may have received first-line treatment either intravenously or intraperitoneally.
* Patients must NOT have received prior therapy with pemetrexed or bevacizumab.
* Patients may have received a total of \< 2 prior cytotoxic chemotherapy regimens (adjuvant therapy plus one additional regimen). Consolidation or extended therapy as part of first line treatment will be considered as a single regimen.
* Bone marrow function: absolute neutrophil count (ANC) greater than or equal to 1,500/ul, equivalent to Common Toxicity Criteria (CTC) grade 1; Platelets greater than or equal to 100,000/ul.
* Creatinine clearance must be greater than 45 ml/min.
* Hepatic function: bilirubin less than or equal to 1.5 x ULN. AST and alkaline phosphatase less than or equal to 2.5 x ULN.
* Neurologic function: neuropathy (sensory and motor) less than or equal to CTC grade 1.
* Coagulation: prothrombin time (PT) such that the international normalized ratio (INR) is \< 1.5 (INR may be between 2 and 3 if a patient is on stable dose of therapeutic warfarin) and a PTT \< 1.2 times control.
* Patients must have signed informed consent.
* Patients must meet pre-entry requirements.
* Patients of childbearing potential must have a negative serum pregnancy test prior to study entry, be practicing an effective form of contraception, and cannot be lactating.
* Patients may have received prior radiotherapy (to less than 25% of bone marrow), but must start at a Level 1 dose reduction.
Exclusion Criteria
* Patients with serious, non-healing wound, ulcer or bone fracture.
* Patients with clinically significant cardiovascular disease:
* Inadequately controlled hypertension (defined as systolic blood pressure \> 150 and/or diastolic blood pressure \> 100 mmHg on antihypertensive medications)
* Any prior history of hypertensive crisis or hypertensive encephalopathy.
* Unstable angina within 6 months prior to study enrollment.
* New York Heart Association (NYHA) grade II or greater congestive heart failure.
* Serious cardiac arrhythmia requiring medication.
* Grade II or greater peripheral vascular disease. Patients with claudication within 6 months.
* History of myocardial infarction within 6 months.
* Patients with active bleeding or pathologic conditions that carry high risk of bleeding, such as known bleeding disorder, coagulopathy, or tumor involving major vessels.
* Patients with the presence of ascites or other third space fluid which cannot be controlled by drainage.
* Major surgical procedure, open biopsy, or significant traumatic injury within 28 days prior to day 1 of study or anticipation of need for major surgical procedure during the course of the study.
* Patients with history or evidence upon physical examination of central nervous system disease, including primary brain tumor, brain metastases, seizure not controlled with standard medical therapy, history of cerebrovascular accident (CVA, stroke), or transient ischemic attack (TIA) or subarachnoid hemorrhage within 6 months of the first date of treatment on this study.
* Minor surgical procedures, other than central venous access placement, such as fine needle aspiration or core biopsy within 7 days prior to day 1 of study.
* Patients with proteinuria. At baseline patients will undergo a urine protein-creatinine ratio (UPCR) (Appendix IV). Patients with a UPCR \> 1.0 at screening should be excluded. Urine dipstick for proteinuria may also be used. Urine dipstick for proteinuria ≥ 2+ (patients discovered to have ≥2+ proteinuria on dipstick urinalysis at baseline should undergo a 24 hour urine collection and must demonstrate ≤ 1g of protein in 24 hours to be eligible).
* Patients whose circumstances do not permit completion of the study or the required follow-up.
* Patients who are pregnant or nursing.
* Patients under the age of 18.
* Patients with other invasive malignancies, with the exception of non-melanoma skin cancer, who had (or have) any evidence of other cancer within the last 5 years or whose previous cancer treatment contraindicates this protocol.
* Prior therapy with anti-angiogenic agents or pemetrexed.
* Patients with active infection requiring parenteral antibiotics.
* History of abdominal fistula, gastrointestinal perforation or intra-abdominal abscess within 6 months.
* Partial or complete small or large bowel obstruction demonstrated radiographically within 3 months prior to study.
* Current, recent (within 4 weeks of the first infusion of this study), or planned participation in an experimental drug study other than a Genentech-sponsored bevacizumab cancer study.
* Known hypersensitivity to any component of bevacizumab.
* Inability to comply with study and/or follow-up procedures.
* Life expectancy of less than 12 weeks.
* Patients with clinically significant cardiovascular disease:
* Inadequately controlled hypertension (defined as systolic blood pressure \> 150 and/or diastolic blood pressure \> 100 mmHg on antihypertensive medications)
* Any prior history of hypertensive crisis or hypertensive encephalopathy.
* Unstable angina within 6 months prior to study enrollment.
* New York Heart Association (NYHA) grade II or greater congestive heart failure.
* Serious cardiac arrhythmia requiring medication.
* Grade II or greater peripheral vascular disease. Patients with claudication within 6 months.
* History of myocardial infarction within 6 months.
* Patients with active bleeding or pathologic conditions that carry high risk of bleeding, such as known bleeding disorder, coagulopathy, or tumor involving major vessels.
* Patients with the presence of ascites or other third space fluid which cannot be controlled by drainage.
* Major surgical procedure, open biopsy, or significant traumatic injury within 28 days prior to day 1 of study or anticipation of need for major surgical procedure during the course of the study.
* Patients with history or evidence upon physical examination of central nervous system disease, including primary brain tumor, brain metastases, seizure not controlled with standard medical therapy, history of cerebrovascular accident (CVA, stroke), or transient ischemic attack (TIA) or subarachnoid hemorrhage within 6 months of the first date of treatment on this study.
* Minor surgical procedures, other than central venous access placement, such as fine needle aspiration or core biopsy within 7 days prior to day 1 of study.
* Patients with proteinuria. At baseline patients will undergo a urine protein-creatinine ratio (UPCR) (Appendix IV). Patients with a UPCR \> 1.0 at screening should be excluded. Urine dipstick for proteinuria may also be used. Urine dipstick for proteinuria ≥ 2+ (patients discovered to have ≥2+ proteinuria on dipstick urinalysis at baseline should undergo a 24 hour urine collection and must demonstrate ≤ 1g of protein in 24 hours to be eligible).
* Patients whose circumstances do not permit completion of the study or the required follow-up.
* Patients who are pregnant or nursing.
* Patients under the age of 18.
* Patients with other invasive malignancies, with the exception of non-melanoma skin cancer, who had (or have) any evidence of other cancer within the last 5 years or whose previous cancer treatment contraindicates this protocol.
* Prior therapy with anti-angiogenic agents or pemetrexed.
* Patients with active infection requiring parenteral antibiotics.
* History of abdominal fistula, gastrointestinal perforation or intra-abdominal abscess within 6 months.
* Partial or complete small or large bowel obstruction demonstrated radiographically within 3 months prior to study.
* Current, recent (within 4 weeks of the first infusion of this study), or planned participation in an experimental drug study other than a Genentech-sponsored bevacizumab cancer study.
* Known hypersensitivity to any component of bevacizumab.
* Inability to comply with study and/or follow-up procedures.
* Life expectancy of less than 12 weeks.
Minimum Eligible Age
18 Years
Eligible Sex
FEMALE
Accepts Healthy Volunteers
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Columbia University
OTHER
Sponsor Role
collaborator
Washington University School of Medicine
OTHER
Sponsor Role
lead
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Responsibility Role
SPONSOR
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
David G Mutch, M.D.
Role: PRINCIPAL_INVESTIGATOR
Washington University School of Medicine
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Washington University School of Medicine
St Louis, Missouri, United States
Site Status
Countries
Review the countries where the study has at least one active or historical site.
United States
References
Explore related publications, articles, or registry entries linked to this study.
Jemal A, Siegel R, Ward E, Murray T, Xu J, Smigal C, Thun MJ. Cancer statistics, 2006. CA Cancer J Clin. 2006 Mar-Apr;56(2):106-30. doi: 10.3322/canjclin.56.2.106.
Reference Type
BACKGROUND
McGuire WP, Hoskins WJ, Brady MF, Kucera PR, Partridge EE, Look KY, Clarke-Pearson DL, Davidson M. Cyclophosphamide and cisplatin compared with paclitaxel and cisplatin in patients with stage III and stage IV ovarian cancer. N Engl J Med. 1996 Jan 4;334(1):1-6. doi: 10.1056/NEJM199601043340101.
Reference Type
BACKGROUND
Alberts DS, Green S, Hannigan EV, O'Toole R, Stock-Novack D, Anderson P, Surwit EA, Malvlya VK, Nahhas WA, Jolles CJ. Improved therapeutic index of carboplatin plus cyclophosphamide versus cisplatin plus cyclophosphamide: final report by the Southwest Oncology Group of a phase III randomized trial in stages III and IV ovarian cancer. J Clin Oncol. 1992 May;10(5):706-17. doi: 10.1200/JCO.1992.10.5.706.
Reference Type
BACKGROUND
Ozols RF, Bundy BN, Greer BE, Fowler JM, Clarke-Pearson D, Burger RA, Mannel RS, DeGeest K, Hartenbach EM, Baergen R; Gynecologic Oncology Group. Phase III trial of carboplatin and paclitaxel compared with cisplatin and paclitaxel in patients with optimally resected stage III ovarian cancer: a Gynecologic Oncology Group study. J Clin Oncol. 2003 Sep 1;21(17):3194-200. doi: 10.1200/JCO.2003.02.153. Epub 2003 Jul 14.
Reference Type
BACKGROUND
Swenerton K, Jeffrey J, Stuart G, Roy M, Krepart G, Carmichael J, Drouin P, Stanimir R, O'Connell G, MacLean G, et al. Cisplatin-cyclophosphamide versus carboplatin-cyclophosphamide in advanced ovarian cancer: a randomized phase III study of the National Cancer Institute of Canada Clinical Trials Group. J Clin Oncol. 1992 May;10(5):718-26. doi: 10.1200/JCO.1992.10.5.718.
Reference Type
BACKGROUND
Kosary CL. FIGO stage, histology, histologic grade, age and race as prognostic factors in determining survival for cancers of the female gynecological system: an analysis of 1973-87 SEER cases of cancers of the endometrium, cervix, ovary, vulva, and vagina. Semin Surg Oncol. 1994 Jan-Feb;10(1):31-46. doi: 10.1002/ssu.2980100107.
Reference Type
BACKGROUND
Folkman J. What is the evidence that tumors are angiogenesis dependent? J Natl Cancer Inst. 1990 Jan 3;82(1):4-6. doi: 10.1093/jnci/82.1.4. No abstract available.
Reference Type
BACKGROUND
Weidner N, Folkman J, Pozza F, Bevilacqua P, Allred EN, Moore DH, Meli S, Gasparini G. Tumor angiogenesis: a new significant and independent prognostic indicator in early-stage breast carcinoma. J Natl Cancer Inst. 1992 Dec 16;84(24):1875-87. doi: 10.1093/jnci/84.24.1875.
Reference Type
BACKGROUND
Weidner N, Semple JP, Welch WR, Folkman J. Tumor angiogenesis and metastasis--correlation in invasive breast carcinoma. N Engl J Med. 1991 Jan 3;324(1):1-8. doi: 10.1056/NEJM199101033240101.
Reference Type
BACKGROUND
Tammela T, Enholm B, Alitalo K, Paavonen K. The biology of vascular endothelial growth factors. Cardiovasc Res. 2005 Feb 15;65(3):550-63. doi: 10.1016/j.cardiores.2004.12.002.
Reference Type
BACKGROUND
Rosen LS. VEGF-targeted therapy: therapeutic potential and recent advances. Oncologist. 2005 Jun-Jul;10(6):382-91. doi: 10.1634/theoncologist.10-6-382.
Reference Type
BACKGROUND
Ferrara N, Kerbel RS. Angiogenesis as a therapeutic target. Nature. 2005 Dec 15;438(7070):967-74. doi: 10.1038/nature04483.
Reference Type
BACKGROUND
Zhang L, Yang N, Garcia JR, Mohamed A, Benencia F, Rubin SC, Allman D, Coukos G. Generation of a syngeneic mouse model to study the effects of vascular endothelial growth factor in ovarian carcinoma. Am J Pathol. 2002 Dec;161(6):2295-309. doi: 10.1016/s0002-9440(10)64505-1.
Reference Type
BACKGROUND
Goodheart MJ, Ritchie JM, Rose SL, Fruehauf JP, De Young BR, Buller RE. The relationship of molecular markers of p53 function and angiogenesis to prognosis of stage I epithelial ovarian cancer. Clin Cancer Res. 2005 May 15;11(10):3733-42. doi: 10.1158/1078-0432.CCR-04-0056.
Reference Type
BACKGROUND
Abulafia O, Ruiz JE, Holcomb K, Dimaio TM, Lee YC, Sherer DM. Angiogenesis in early-invasive and low-malignant-potential epithelial ovarian carcinoma. Obstet Gynecol. 2000 Apr;95(4):548-52. doi: 10.1016/s0029-7844(99)00608-0.
Reference Type
BACKGROUND
Alvarez AA, Krigman HR, Whitaker RS, Dodge RK, Rodriguez GC. The prognostic significance of angiogenesis in epithelial ovarian carcinoma. Clin Cancer Res. 1999 Mar;5(3):587-91.
Reference Type
BACKGROUND
Stone PJ, Goodheart MJ, Rose SL, Smith BJ, DeYoung BR, Buller RE. The influence of microvessel density on ovarian carcinogenesis. Gynecol Oncol. 2003 Sep;90(3):566-71. doi: 10.1016/s0090-8258(03)00367-6.
Reference Type
BACKGROUND
Bamberger ES, Perrett CW. Angiogenesis in epithelian ovarian cancer. Mol Pathol. 2002 Dec;55(6):348-59. doi: 10.1136/mp.55.6.348.
Reference Type
BACKGROUND
Gasparini G, Bonoldi E, Viale G, Verderio P, Boracchi P, Panizzoni GA, Radaelli U, Di Bacco A, Guglielmi RB, Bevilacqua P. Prognostic and predictive value of tumour angiogenesis in ovarian carcinomas. Int J Cancer. 1996 Jun 21;69(3):205-11. doi: 10.1002/(SICI)1097-0215(19960621)69:33.0.CO;2-6.
Reference Type
BACKGROUND
Hollingsworth HC, Kohn EC, Steinberg SM, Rothenberg ML, Merino MJ. Tumor angiogenesis in advanced stage ovarian carcinoma. Am J Pathol. 1995 Jul;147(1):33-41.
Reference Type
BACKGROUND
Orre M, Lotfi-Miri M, Mamers P, Rogers PA. Increased microvessel density in mucinous compared with malignant serous and benign tumours of the ovary. Br J Cancer. 1998 Jun;77(12):2204-9. doi: 10.1038/bjc.1998.367.
Reference Type
BACKGROUND
Obermair A, Wasicky R, Kaider A, Preyer O, Losch A, Leodolter S, Kolbl H. Prognostic significance of tumor angiogenesis in epithelial ovarian cancer. Cancer Lett. 1999 Apr 26;138(1-2):175-82. doi: 10.1016/s0304-3835(99)00005-1.
Reference Type
BACKGROUND
Sonmezer M, Gungor M, Ensari A, Ortac F. Prognostic significance of tumor angiogenesis in epithelial ovarian cancer: in association with transforming growth factor beta and vascular endothelial growth factor. Int J Gynecol Cancer. 2004 Jan-Feb;14(1):82-8. doi: 10.1111/j.1048-891x.2004.14202.x.
Reference Type
BACKGROUND
Paley PJ, Staskus KA, Gebhard K, Mohanraj D, Twiggs LB, Carson LF, Ramakrishnan S. Vascular endothelial growth factor expression in early stage ovarian carcinoma. Cancer. 1997 Jul 1;80(1):98-106. doi: 10.1002/(sici)1097-0142(19970701)80:13.0.co;2-a.
Reference Type
BACKGROUND
Shen GH, Ghazizadeh M, Kawanami O, Shimizu H, Jin E, Araki T, Sugisaki Y. Prognostic significance of vascular endothelial growth factor expression in human ovarian carcinoma. Br J Cancer. 2000 Jul;83(2):196-203. doi: 10.1054/bjoc.2000.1228.
Reference Type
BACKGROUND
Orre M, Rogers PA. VEGF, VEGFR-1, VEGFR-2, microvessel density and endothelial cell proliferation in tumours of the ovary. Int J Cancer. 1999 Apr 20;84(2):101-8. doi: 10.1002/(sici)1097-0215(19990420)84:23.0.co;2-5.
Reference Type
BACKGROUND
Hartenbach EM, Olson TA, Goswitz JJ, Mohanraj D, Twiggs LB, Carson LF, Ramakrishnan S. Vascular endothelial growth factor (VEGF) expression and survival in human epithelial ovarian carcinomas. Cancer Lett. 1997 Dec 23;121(2):169-75. doi: 10.1016/s0304-3835(97)00350-9.
Reference Type
BACKGROUND
Nakanishi Y, Kodama J, Yoshinouchi M, Tokumo K, Kamimura S, Okuda H, Kudo T. The expression of vascular endothelial growth factor and transforming growth factor-beta associates with angiogenesis in epithelial ovarian cancer. Int J Gynecol Pathol. 1997 Jul;16(3):256-62. doi: 10.1097/00004347-199707000-00011.
Reference Type
BACKGROUND
Hurwitz H, Fehrenbacher L, Novotny W, Cartwright T, Hainsworth J, Heim W, Berlin J, Baron A, Griffing S, Holmgren E, Ferrara N, Fyfe G, Rogers B, Ross R, Kabbinavar F. Bevacizumab plus irinotecan, fluorouracil, and leucovorin for metastatic colorectal cancer. N Engl J Med. 2004 Jun 3;350(23):2335-42. doi: 10.1056/NEJMoa032691.
Reference Type
BACKGROUND
Yang JC, Haworth L, Sherry RM, Hwu P, Schwartzentruber DJ, Topalian SL, Steinberg SM, Chen HX, Rosenberg SA. A randomized trial of bevacizumab, an anti-vascular endothelial growth factor antibody, for metastatic renal cancer. N Engl J Med. 2003 Jul 31;349(5):427-34. doi: 10.1056/NEJMoa021491.
Reference Type
BACKGROUND
Miller KD, Chap LI, Holmes FA, Cobleigh MA, Marcom PK, Fehrenbacher L, Dickler M, Overmoyer BA, Reimann JD, Sing AP, Langmuir V, Rugo HS. Randomized phase III trial of capecitabine compared with bevacizumab plus capecitabine in patients with previously treated metastatic breast cancer. J Clin Oncol. 2005 Feb 1;23(4):792-9. doi: 10.1200/JCO.2005.05.098.
Reference Type
BACKGROUND
Burger RA, Sill MW, Monk BJ, Greer BE, Sorosky JI. Phase II trial of bevacizumab in persistent or recurrent epithelial ovarian cancer or primary peritoneal cancer: a Gynecologic Oncology Group Study. J Clin Oncol. 2007 Nov 20;25(33):5165-71. doi: 10.1200/JCO.2007.11.5345.
Reference Type
BACKGROUND
Garcia AA, Hirte H, Fleming G, Yang D, Tsao-Wei DD, Roman L, Groshen S, Swenson S, Markland F, Gandara D, Scudder S, Morgan R, Chen H, Lenz HJ, Oza AM. Phase II clinical trial of bevacizumab and low-dose metronomic oral cyclophosphamide in recurrent ovarian cancer: a trial of the California, Chicago, and Princess Margaret Hospital phase II consortia. J Clin Oncol. 2008 Jan 1;26(1):76-82. doi: 10.1200/JCO.2007.12.1939.
Reference Type
BACKGROUND
Cannistra SA, Matulonis UA, Penson RT, Hambleton J, Dupont J, Mackey H, Douglas J, Burger RA, Armstrong D, Wenham R, McGuire W. Phase II study of bevacizumab in patients with platinum-resistant ovarian cancer or peritoneal serous cancer. J Clin Oncol. 2007 Nov 20;25(33):5180-6. doi: 10.1200/JCO.2007.12.0782.
Reference Type
BACKGROUND
Shih C, Chen VJ, Gossett LS, Gates SB, MacKellar WC, Habeck LL, Shackelford KA, Mendelsohn LG, Soose DJ, Patel VF, Andis SL, Bewley JR, Rayl EA, Moroson BA, Beardsley GP, Kohler W, Ratnam M, Schultz RM. LY231514, a pyrrolo[2,3-d]pyrimidine-based antifolate that inhibits multiple folate-requiring enzymes. Cancer Res. 1997 Mar 15;57(6):1116-23.
Reference Type
BACKGROUND
Alati T, Worzalla JF, Shih C, Bewley JR, Lewis S, Moran RG, Grindey GB. Augmentation of the therapeutic activity of lometrexol -(6-R)5,10-dideazatetrahydrofolate- by oral folic acid. Cancer Res. 1996 May 15;56(10):2331-5.
Reference Type
BACKGROUND
Ozcan C, Wong SJ, Hari P. Reversible posterior leukoencephalopathy syndrome and bevacizumab. N Engl J Med. 2006 Mar 2;354(9):980-2; discussion 980-2. No abstract available.
Reference Type
BACKGROUND
Glusker P, Recht L, Lane B. Reversible posterior leukoencephalopathy syndrome and bevacizumab. N Engl J Med. 2006 Mar 2;354(9):980-2; discussion 980-2. doi: 10.1056/NEJMc052954. No abstract available.
Reference Type
BACKGROUND
Therasse P, Arbuck SG, Eisenhauer EA, Wanders J, Kaplan RS, Rubinstein L, Verweij J, Van Glabbeke M, van Oosterom AT, Christian MC, Gwyther SG. New guidelines to evaluate the response to treatment in solid tumors. European Organization for Research and Treatment of Cancer, National Cancer Institute of the United States, National Cancer Institute of Canada. J Natl Cancer Inst. 2000 Feb 2;92(3):205-16. doi: 10.1093/jnci/92.3.205.
Reference Type
BACKGROUND
Jubb AM, Hurwitz HI, Bai W, Holmgren EB, Tobin P, Guerrero AS, Kabbinavar F, Holden SN, Novotny WF, Frantz GD, Hillan KJ, Koeppen H. Impact of vascular endothelial growth factor-A expression, thrombospondin-2 expression, and microvessel density on the treatment effect of bevacizumab in metastatic colorectal cancer. J Clin Oncol. 2006 Jan 10;24(2):217-27. doi: 10.1200/JCO.2005.01.5388. Epub 2005 Dec 19.
Reference Type
BACKGROUND
Bibikova M, Talantov D, Chudin E, Yeakley JM, Chen J, Doucet D, Wickham E, Atkins D, Barker D, Chee M, Wang Y, Fan JB. Quantitative gene expression profiling in formalin-fixed, paraffin-embedded tissues using universal bead arrays. Am J Pathol. 2004 Nov;165(5):1799-807. doi: 10.1016/S0002-9440(10)63435-9.
Reference Type
BACKGROUND
Bibikova M, Yeakley JM, Chudin E, Chen J, Wickham E, Wang-Rodriguez J, Fan JB. Gene expression profiles in formalin-fixed, paraffin-embedded tissues obtained with a novel assay for microarray analysis. Clin Chem. 2004 Dec;50(12):2384-6. doi: 10.1373/clinchem.2004.037432. No abstract available.
Reference Type
BACKGROUND
Fan JB, Yeakley JM, Bibikova M, Chudin E, Wickham E, Chen J, Doucet D, Rigault P, Zhang B, Shen R, McBride C, Li HR, Fu XD, Oliphant A, Barker DL, Chee MS. A versatile assay for high-throughput gene expression profiling on universal array matrices. Genome Res. 2004 May;14(5):878-85. doi: 10.1101/gr.2167504.
Reference Type
BACKGROUND
Related Links
Access external resources that provide additional context or updates about the study.
http://www.siteman.wustl.edu
Alvin J. Siteman Cancer Center at Barnes-Jewish Hospital and Washington University School of Medicine
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
08-0508 / 201102272
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.
Bevacizumab and Erlotinib in Treating Patients With Recurrent or Metastatic Ovarian Epithelial, Fallopian Tube, or Primary Peritoneal Cavity Cancer
NCT00126542
COMPLETED
PHASE2
A Study of Bevacizumab in Ovarian Cancer or Primary Peritoneal Cancer Where Doxil or Topotecan Therapy Has Failed
NCT00097019
COMPLETED
PHASE2
Irinotecan Liposome and Bevacizumab for the Treatment of Platinum Resistant, Recurrent, or Refractory Ovarian, Fallopian Tube, or Primary Peritoneal Cancer
NCT04753216
COMPLETED
PHASE2
Bevacizumab Study With Carboplatin & Paclitaxel in Ovarian, Fallopian Tube or Primary Peritoneal Cancer
NCT00408070
TERMINATED
PHASE2
Pemetrexed Disodium in Treating Patients With Ovarian Epithelial Cancer or Primary Peritoneal Cancer
NCT00087087
COMPLETED
PHASE2
Bevacizumab With or Without Fosbretabulin Tromethamine in Treating Patients With Recurrent or Persistent Ovarian Epithelial, Fallopian Tube, or Peritoneal Cavity Cancer
NCT01305213
COMPLETED
PHASE2
Irinotecan and Bevacizumab for Recurrent Ovarian Cancer
NCT01091259
COMPLETED
PHASE2
Temsirolimus and Bevacizumab in Treating Patients With Advanced Endometrial, Ovarian, Liver, Carcinoid, or Islet Cell Cancer
NCT01010126
COMPLETED
PHASE2
Pembrolizumab, Bevacizumab, and Cyclophosphamide in Treating Patients With Recurrent Ovarian, Fallopian Tube, or Primary Peritoneal Cancer
NCT02853318
COMPLETED
PHASE2
Bevacizumab in Treating Patients With Persistent or Recurrent Ovarian Epithelial Cancer or Primary Peritoneal Cancer
NCT00022659
COMPLETED
PHASE2
CRLX101 in Combination With Bevacizumab for Recurrent Ovarian/Tubal/Peritoneal Cancer
NCT01652079
COMPLETED
PHASE2
Paclitaxel, Bevacizumab And Adjuvant Intraperitoneal Carboplatin in Treating Patients Who Had Initial Debulking Surgery for Stage II, Stage III, or Stage IV Ovarian Epithelial, Primary Peritoneal, or Fallopian Tube Cancer
NCT00079430
COMPLETED
PHASE1
Pembrolizumab and Bevacizumab With Chemotherapy Followed by Pembrolizumab, Bevacizumab and Olaparib in Recurrent Ovarian Cancer
NCT05158062
UNKNOWN
PHASE2
Study of Gemcitabine/Carboplatin/Bevacizumab to Treat Ovarian, Fallopian Tube or Primary Peritoneal Cancer
NCT00267696
COMPLETED
PHASE2
Study of Pemetrexed in the Treatment of Patients With Ovarian Cancer Who Have Failed Prior Platinum-Based Chemotherapy
NCT00109096
COMPLETED
PHASE2
Pegylated Liposomal Doxorubicin Hydrochloride With Atezolizumab and/or Bevacizumab in Treating Patients With Recurrent Ovarian, Fallopian Tube, or Primary Peritoneal Cancer
NCT02839707
ACTIVE_NOT_RECRUITING
PHASE2/PHASE3
Sorafenib and Bevacizumab to Treat Ovarian, Fallopian and Peritoneal Cancer
NCT00436215
COMPLETED
PHASE2
APL-2 and Pembrolizumab Versus APL-2, Pembrolizumab and Bevacizumab Versus Bevacizumab Alone for the Treatment of Recurrent Ovarian, Fallopian Tube, or Primary Peritoneal Cancer and Malignant Effusion
NCT04919629
RECRUITING
PHASE2
Bevacizumab and Intravenous or Intraperitoneal Chemotherapy in Treating Patients With Stage II-III Ovarian Epithelial Cancer, Fallopian Tube Cancer, or Primary Peritoneal Cancer
NCT00951496
COMPLETED
PHASE3
Chemotherapy With or Without Peripheral Stem Cell Transplantation in Treating Patients With Persistent Ovarian Epithelial Cancer
NCT00002819
TERMINATED
PHASE3
Gemcitabine and Docetaxel in Treating Patients With Relapsed or Refractory Ovarian Epithelial or Peritoneal Cancer
NCT00227721
COMPLETED
PHASE2
Study of Intraperitoneal Carboplatin With IV Paclitaxel and Bevacizumab in Untreated Ovarian Cancer
NCT01220154
COMPLETED
PHASE1
Carboplatin, Paclitaxel and Gemcitabine Hydrochloride With or Without Bevacizumab After Surgery in Treating Patients With Recurrent Ovarian, Epithelial, Primary Peritoneal, or Fallopian Tube Cancer
NCT00565851
ACTIVE_NOT_RECRUITING
PHASE3
Neoadjuvant Therapy for Ovarian Cancer
NCT01146795
COMPLETED
PHASE2