Home
Search
Study Topics
Glossary
|
|
|
|
|
|
Sponsors and Collaborators: |
Gynecologic Oncology Group National Cancer Institute (NCI) |
---|---|
Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00262847 |
RATIONALE: Drugs used in chemotherapy, such as carboplatin and paclitaxel, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Monoclonal antibodies, such as bevacizumab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Bevacizumab may also stop the growth of tumor cells by blocking blood flow to the tumor. It is not yet known whether carboplatin, paclitaxel, and bevacizumab are more effective than carboplatin, paclitaxel, and placebo in treating ovarian epithelial or primary peritoneal cancer , or fallopian tube cancer
PURPOSE: This randomized phase III trial is studying carboplatin, paclitaxel, and bevacizumab to see how well they work compared to carboplatin, paclitaxel, and placebo in treating patients with stage III or stage IV ovarian epithelial, primary peritoneal cancer, or fallopian tube cancer.
Condition | Intervention | Phase |
---|---|---|
Fallopian Tube Cancer Ovarian Cancer Peritoneal Cavity Cancer |
Drug: bevacizumab Drug: carboplatin Drug: paclitaxel Drug: placebo |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double-Blind, Placebo Control |
Official Title: | A Phase III Trial of Carboplatin and Paclitaxel Plus Placebo Versus Carboplatin and Paclitaxel Plus Concurrent Bevacizumab (NSC # 704865, IND #7921) Followed By Placebo, Versus Carboplatin and Paclitaxel Plus Concurrent and Extended Bevacizumab, in Women With Newly Diagnosed, Previously Untreated, Suboptimal Advanced Stage Epithelial Ovarian, Primary Peritoneal Cancer, or Fallopian Tube Cancer |
Estimated Enrollment: | 2000 |
Study Start Date: | September 2005 |
Estimated Primary Completion Date: | October 2008 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
Arm I: Active Comparator
Beginning in course 2 of chemotherapy, patients receive placebo IV over 30-90 minutes on day 1. Treatment repeats every 21 days for 6 courses. Beginning in course 7, patients receive placebo alone IV over 30-90 minutes on day 1. Treatment with placebo repeats every 21 days for up to 22 courses.
|
Drug: carboplatin
Given IV
Drug: paclitaxel
Given IV
Drug: placebo
Given IV
|
Arm II: Experimental
Beginning in course 2 of chemotherapy, patients receive bevacizumab IV over 30-90 minutes on day 1.Treatment repeats every 21 days for 6 courses. Beginning in course 7, patients receive placebo alone IV over 30-90 minutes on day 1. Treatment with placebo repeats every 21 days for up to 22 courses.
|
Drug: bevacizumab
Given IV
Drug: carboplatin
Given IV
Drug: paclitaxel
Given IV
Drug: placebo
Given IV
|
Arm III: Experimental
Beginning in course 2 of chemotherapy, patients receive bevacizumab IV over 30-90 minutes on day 1. Treatment repeats every 21 days for 6 courses. Beginning in course 7, patients receive bevacizumab alone IV over 30-90 minutes on day 1. Treatment with bevacizumab repeats every 21 days for up to 22 courses.
|
Drug: bevacizumab
Given IV
Drug: carboplatin
Given IV
Drug: paclitaxel
Given IV
|
OBJECTIVES:
Primary
Secondary
Tertiary
OUTLINE: This is a randomized, double-blind, placebo-controlled, multicenter study. Patients are stratified according to stage of disease (III vs IV) or initial performance status (0 vs 1 vs 2). Patients are randomized to 1 of 3 treatment arms.
Quality of life is assessed at baseline, before courses 4, 7, 13, and 21, and then at 6 months after study completion.
After completion of study treatment, patients are followed periodically for at least 5 years.
PROJECTED ACCRUAL: A total of 2,000 patients will be accrued for this study.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically confirmed ovarian epithelial, primary peritoneal*, or fallopian tube cancer
The following histologic epithelial cell types are allowed provided the histologic features of the tumor are compatible with a primary müllerian epithelial adenocarcinoma:
No borderline ovarian epithelial tumor (formerly "tumors of low malignant potential")
No synchronous primary endometrial cancer or prior primary endometrial cancer unless all of the following criteria are met:
Must have undergone surgery for ovarian epithelial, primary peritoneal, or fallopian tube cancer in the past 1-12 weeks AND have tissue available for histologic evaluation
PATIENT CHARACTERISTICS:
Performance status
Life expectancy
Hematopoietic
Hepatic
Renal
Cardiovascular
Other
No history of abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess within the past 28 days
PRIOR CONCURRENT THERAPY:
Biologic therapy
No prior targeted therapy for ovarian epithelial or peritoneal primary cancer, including, but not limited to, any of the following:
Chemotherapy
Endocrine therapy
Ovarian estrogen with or without progestin replacement therapy as indicated at the lowest effective dose(s) for control of menopausal symptoms at any time allowed
Radiotherapy
Surgery
Other
Study Chair: | Robert A. Burger, MD | Chao Family Comprehensive Cancer Center |
Investigator: | Gini F. Fleming, MD | University of Chicago |
Study ID Numbers: | CDR0000455114, GOG-0218 |
Study First Received: | December 6, 2005 |
Last Updated: | January 15, 2009 |
ClinicalTrials.gov Identifier: | NCT00262847 |
Health Authority: | Unspecified |
stage III ovarian epithelial cancer stage IV ovarian epithelial cancer peritoneal cavity cancer ovarian clear cell cystadenocarcinoma ovarian endometrioid adenocarcinoma ovarian mixed epithelial carcinoma |
ovarian mucinous cystadenocarcinoma ovarian serous cystadenocarcinoma Brenner tumor ovarian undifferentiated adenocarcinoma fallopian tube cancer |
Cystadenocarcinoma, Serous Gonadal Disorders Urogenital Neoplasms Bevacizumab Ovarian Diseases Ovarian epithelial cancer Carcinoma, Endometrioid Genital Diseases, Female Peritoneal Diseases Endocrine Gland Neoplasms Ovarian cancer Ovarian Neoplasms Digestive System Neoplasms Genital Neoplasms, Female |
Endocrine System Diseases Carboplatin Abdominal Neoplasms Fallopian Tube Neoplasms Carcinoma Fallopian Tube Diseases Digestive System Diseases Paclitaxel Gastrointestinal Neoplasms Peritoneal Neoplasms Fallopian tube cancer Endocrinopathy Adenocarcinoma |
Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Growth Substances Physiological Effects of Drugs Mitosis Modulators Antimitotic Agents Angiogenesis Inhibitors Pharmacologic Actions |
Adnexal Diseases Neoplasms Neoplasms by Site Therapeutic Uses Tubulin Modulators Growth Inhibitors Angiogenesis Modulating Agents Antineoplastic Agents, Phytogenic |