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A Study of Bevacizumab in Ovarian Cancer or Primary Peritoneal Cancer Where Doxil or Topotecan Therapy Has Failed | Clinical Trials | Clareo Health

COMPLETEDPHASE2

A Study of Bevacizumab in Ovarian Cancer or Primary Peritoneal Cancer Where Doxil or Topotecan Therapy Has Failed

A Multicenter, Single-Arm, Phase II Trial of Bevacizumab in Subjects With Platinum-Resistant Epithelial Carcinoma of the Ovary or Primary Peritoneal Carcinoma for Whom Subsequent Doxil or Topotecan Therapy Has Failed

NCT00097019•Genentech, Inc.

View on ClinicalTrials.gov

Summary

This is an open-label, single-arm, two-stage, multicenter Phase II study evaluating the efficacy and safety of bevacizumab in women with platinum resistant, advanced (Stage III or IV) EOC (epithelial ovarian cancer) or PPC (primary peritoneal cancer) that subsequently progressed either during treatment with Doxil or Hycamtin therapy or within 3 months of discontinuing treatment with Doxil or Hycamtin therapy.

Eligibility

Age

18 - No limit years

Sex

FEMALE

Healthy Volunteers

Inclusion Criteria

•Signed informed consent
•Female, age \>=18 years
•Advanced (Stage III or IV), histologically documented epithelial ovarian cancer or primary peritoneal cancer
•Platinum-resistant disease
•Platinum-resistant disease that subsequently progressed either during treatment with Doxil(R) or Hycamtin(R) therapy or within 3 months of discontinuing treatment with Doxil(R) or Hycamtin(R) therapy
•Received no more than three treatment regimens
•Measurable disease with at least one lesion that can be accurately measured in at least one dimension (longest dimension recorded) according to RECIST (with the exception that spiral CT scans of up to 8-mm slice thickness will be accepted)
•Recovered from prior cancer therapy (XRT, surgery, chemotherapy)
•ECOG performance status 0 or 1
•Life expectancy \>12 weeks
+1 more criteria

Exclusion Criteria

•Four or more treatment regimens
•Prior therapy with bevacizumab or other VEGF pathway-targeted therapy
•Current, recent (within 4 weeks of the first infusion of bevacizumab), or planned treatment with an experimental drug other than this Genentech-sponsored bevacizumab cancer study
•Screening clinical laboratory values: Granulocyte count \<1500/uL; Platelet count \<75,000/uL; Hemoglobin \<8.5 g/dL (hemoglobin may be supported by transfusion or erythropoietin or other approved hematopoietic growth factors; darbopoeitin \[Aranesp(R)\] is permitted); Serum bilirubin \>2.0 x upper limits of normal (ULN); Alkaline phosphatase, AST, and ALT \>2.5 x ULN (AST, ALT \>5 x ULN for subjects with liver metastasis); Serum creatinine \>2.0; International normalized ratio (INR) \>1.5 and activated partial thromboplastin time (aPTT) \>1.5 x ULN (except for subjects receiving anticoagulation therapy); Urine protein/creatinine ratio \>1.0 at screening
•Blood pressure \>150/100 mmHg
•Unstable angina
•New York Heart Association (NYHA) Grade II or greater congestive heart failure (see Appendix B). Women who have received prior Doxil(R) therapy and have an ejection fraction \<50% will be excluded from the study.
•History of myocardial infarction within 6 months prior to Day 0 (the day of the first bevacizumab infusion)
•History of stroke or transient ischemic attack within 6 months prior to Day 0
•Clinically significant peripheral vascular disease
+10 more criteria

Key Dates

Start Date

February 1, 2005

Primary Completion Date

May 1, 2006

Completion Date

May 1, 2006

Last Updated

May 16, 2017

Enrollment

Estimated participants

Conditions

Ovarian Cancer

Interventions

bevacizumab

DRUG

IACS-6274 With or Without Bevacizumab and Paclitaxel for the Treatment of Advanced Solid Tumors

NCT05039801

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RECRUITINGPHASE2

Measuring the Effects of Talazoparib in Patients With Advanced Cancer and DNA Repair Variations

NCT04550494

Anatomic Stage III Breast Cancer AJCC v8Anatomic Stage IV Breast Cancer AJCC v8+29 more

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: May 16, 2017Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

A Study of Bevacizumab in Ovarian Cancer or Primary Peritoneal Cancer Where Doxil or Topotecan Therapy Has Failed

Inclusion Criteria

Exclusion Criteria

IACS-6274 With or Without Bevacizumab and Paclitaxel for the Treatment of Advanced Solid Tumors

Measuring the Effects of Talazoparib in Patients With Advanced Cancer and DNA Repair Variations

Study of Dato-DXd as Monotherapy and in Combination With Anti-cancer Agents in Patients With Advanced Solid Tumours (TROPION-PanTumor03)

Efficacy & Safety of Olvi-Vec and Platinum-doublet + Bevacizumab Compared to Physician's Choice of Chemotherapy and Bevacizumab in Platinum-Resistant/Refractory Ovarian Cancer (PRROC) (OnPrime, GOG-3076)

A Study of ART0380 for the Treatment of Advanced or Metastatic Solid Tumors

The Evaluation of PC14586 in Patients With Advanced Solid Tumors Harboring a TP53 Y220C Mutation (PYNNACLE)