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| Sponsor: | Gynecologic Oncology Group |
|---|---|
| Collaborator: |
National Cancer Institute (NCI) |
| Information provided by: | National Cancer Institute (NCI) |
| ClinicalTrials.gov Identifier: | NCT00022659 |
Purpose
RATIONALE: Monoclonal antibodies, such as bevacizumab, can block cancer growth in different ways. Some block the ability of cancer cells to grow and spread. Others find cancer cells and help kill them or deliver cancer-killing substances to them.
PURPOSE: This phase II trial is to see if bevacizumab works in treating patients who have persistent or recurrent ovarian epithelial cancer or primary peritoneal cancer.
| Condition | Intervention | Phase |
|---|---|---|
|
Ovarian Cancer Primary Peritoneal Cavity Cancer |
Biological: bevacizumab |
Phase II |
| Study Type: | Interventional |
| Study Design: | Masking: Open Label Primary Purpose: Treatment |
| Official Title: | A Phase II Evaluation Of Bevacizumab (Anti-VEGF Humanized Monoclonal Antibody) (NSC #704865, IND #7921) In The Treatment of Persistent Or Recurrent Epithelial Ovarian Or Primary Peritoneal Carcinoma |
| Study Start Date: | April 2002 |
| Primary Completion Date: | March 2010 (Final data collection date for primary outcome measure) |
OBJECTIVES:
OUTLINE: This is a multicenter study.
Patients receive bevacizumab IV over 30-90 minutes on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
Patients are followed every 3 months for 2 years and then every 6 months for 3 years.
PROJECTED ACCRUAL: A total of 55-62 patients will be accrued for this study within 2.2-2.5 years.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically confirmed ovarian epithelial or primary peritoneal carcinoma
At least 1 unidimensionally measurable target lesion
Received 1 prior platinum-based chemotherapy regimen (e.g., carboplatin, cisplatin, or another organoplatinum compound) for primary disease
PATIENT CHARACTERISTICS:
Age:
Performance status:
Life expectancy:
Hematopoietic:
Hepatic:
Renal:
No proteinuria, as indicated by 1 of the following:
Cardiovascular:
No clinically significant cardiovascular disease, including any of the following:
Other:
PRIOR CONCURRENT THERAPY:
Biologic therapy:
Chemotherapy:
Endocrine therapy:
Radiotherapy:
Surgery:
Other:
Contacts and Locations
Show 32 Study Locations| Study Chair: | Robert A. Burger, MD | Chao Family Comprehensive Cancer Center |
More Information
| ClinicalTrials.gov Identifier: | NCT00022659 History of Changes |
| Other Study ID Numbers: | CDR0000068839, GOG-0170D |
| Study First Received: | August 10, 2001 |
| Last Updated: | December 13, 2011 |
| Health Authority: | United States: Federal Government |
|
stage IV ovarian epithelial cancer recurrent ovarian epithelial cancer primary peritoneal cavity cancer |
|
Ovarian Neoplasms Peritoneal Neoplasms Neoplasms, Glandular and Epithelial Endocrine Gland Neoplasms Neoplasms by Site Neoplasms Ovarian Diseases Adnexal Diseases Genital Diseases, Female Genital Neoplasms, Female Urogenital Neoplasms Endocrine System Diseases Gonadal Disorders Abdominal Neoplasms |
Digestive System Neoplasms Digestive System Diseases Peritoneal Diseases Neoplasms by Histologic Type Bevacizumab Angiogenesis Inhibitors Angiogenesis Modulating Agents Growth Substances Physiological Effects of Drugs Pharmacologic Actions Growth Inhibitors Antineoplastic Agents Therapeutic Uses |