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| Sponsor: | Gynecologic Oncology Group |
|---|---|
| Collaborator: |
National Cancer Institute (NCI) |
| Information provided by: | National Cancer Institute (NCI) |
| ClinicalTrials.gov Identifier: | NCT00262847 |
Purpose
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 Malignant Tumor of Peritoneum |
Biological: bevacizumab Drug: carboplatin Drug: paclitaxel Other: placebo |
Phase III |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Masking: Double-Blind Primary Purpose: Treatment |
| 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 |
|---|---|
|
Active Comparator: Arm I
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
Other: placebo
Given IV
|
|
Experimental: Arm II
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.
|
Biological: bevacizumab
Given IV
Drug: carboplatin
Given IV
Drug: paclitaxel
Given IV
Other: placebo
Given IV
|
|
Experimental: Arm III
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.
|
Biological: 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.
Eligibility| 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
Contacts and Locations
Show 593 Study Locations| Study Chair: | Robert A. Burger, MD | Chao Family Comprehensive Cancer Center |
| Investigator: | Gini F. Fleming, MD | University of Chicago |
More Information
| Responsible Party: | Philip J. DiSaia, Gynecologic Oncology Group |
| ClinicalTrials.gov Identifier: | NCT00262847 History of Changes |
| Other Study ID Numbers: | CDR0000455114, GOG-0218 |
| Study First Received: | December 6, 2005 |
| Last Updated: | March 15, 2011 |
| Health Authority: | United States: Food and Drug Administration |
|
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 |
|
Neoplasms Ovarian Neoplasms Peritoneal Neoplasms Fallopian Tube Neoplasms Endocrine Gland Neoplasms Neoplasms by Site 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 Fallopian Tube Diseases Bevacizumab Carboplatin Paclitaxel Antineoplastic Agents Therapeutic Uses Pharmacologic Actions Tubulin Modulators Antimitotic Agents Mitosis Modulators Molecular Mechanisms of Pharmacological Action Antineoplastic Agents, Phytogenic Angiogenesis Inhibitors |