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

NCT00097019 | Completed Phase 2

• 1 other identifier: AVF2949g
• Study Type: interventional
• Target: 53
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Ovarian Cancer

Keywords

Recurrent ovarian cancer; Refractory ovarian cancer

Interventions

bevacizumab DRUG

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• Use of an effective means of contraception (for women of childbearing potential)

You may not qualify if:

• 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
• Evidence of bleeding diathesis or coagulopathy
• Major surgical procedure, open biopsy, or significant traumatic injury within 28 days prior to Day 0; anticipation of need for major elective surgical procedure during the course of the study
• Minor surgical procedures, fine needle aspirations, or core biopsies within 7 days prior to Day 0
• History of abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess within 6 months prior to Day 0
• Serious, non-healing wound, ulcer, or bone fracture

Sponsors & Collaborators

• Genentech, Inc.: lead

Related Publications (1)

• 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.

  PMID: 18024865 RESULT

MeSH Terms

Conditions

Ovarian Neoplasms

Interventions

Bevacizumab

Condition Hierarchy (Ancestors)

Endocrine Gland Neoplasms; Neoplasms by Site; Neoplasms; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Neoplasms, Female; Urogenital Neoplasms; Genital Diseases; Endocrine System Diseases; Gonadal Disorders

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Study Officials

• Julie Hambleton, M.D.

  Genentech, Inc.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Purpose: TREATMENT
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 17, 2004
• First Posted: November 18, 2004
• Study Start: February 1, 2005
• Primary Completion: May 1, 2006
• Study Completion: May 1, 2006
• Last Updated: May 16, 2017

Record last verified: 2017-05