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| Sponsor: | Gynecologic Oncology Group |
|---|---|
| Collaborator: |
National Cancer Institute (NCI) |
| Information provided by: | National Cancer Institute (NCI) |
| ClinicalTrials.gov Identifier: | NCT00565851 |
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. It is not yet known whether combination chemotherapy is more effective when given with or without bevacizumab after surgery in treating patients with recurrent ovarian epithelial cancer, primary peritoneal cavity cancer, or fallopian tube cancer.
PURPOSE: This randomized phase III trial is studying giving carboplatin and paclitaxel together with or without bevacizumab after surgery to see how well it works in treating patients with recurrent ovarian epithelial cancer, primary peritoneal cavity cancer, or fallopian tube cancer.
| Condition | Intervention | Phase |
|---|---|---|
|
Fallopian Tube Cancer Ovarian Cancer Malignant Tumor of Peritoneum |
Biological: bevacizumab Drug: carboplatin Drug: docetaxel Drug: paclitaxel |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Primary Purpose: Treatment |
| Official Title: | A Phase III Randomized Controlled Clinical Trial of Carboplatin and Paclitaxel Alone or in Combination With Bevacizumab (NSC #704865, IND #7921) Followed by Bevacizumab and Secondary Cytoreduction Surgery in Platinum-Sensitive, Recurrent Ovarian, Peritoneal Primary and Fallopian Tube Cancer |
| Estimated Enrollment: | 660 |
| Study Start Date: | December 2007 |
| Estimated Primary Completion Date: | December 2009 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Active Comparator: Arm I
Patients receive paclitaxel IV over 3 hours or docetaxel IV over 1 hour and carboplatin over 30 minutes on day 1. Treatment repeats every 21 days.
|
Drug: carboplatin
Given IV
Drug: docetaxel
Given IV
Drug: paclitaxel
Given IV
|
|
Experimental: Arm II
Patients receive chemotherapy as in arm I and bevacizumab IV over 30-90 minutes on day 1. Treatment repeats every 21 days.
|
Biological: bevacizumab
Given IV
Drug: carboplatin
Given IV
Drug: docetaxel
Given IV
Drug: paclitaxel
Given IV
|
OBJECTIVES:
Primary
Secondary
OUTLINE: This is a multicenter study. Patients are assigned to 1 of 2 treatment groups. Patients who are not candidates for surgical cytoreduction (i.e., those for whom complete cytoreduction in the estimation of the investigator is impossible or a medical infirmity precludes exploration and debulking) are eligible to receive chemotherapy after randomization. Patients who are eligible for surgery undergo abdominal exploration with cytoreduction and undergo tumor tissue collection and complete a quality of life questionnaire before and after surgery. All patients are then randomized to 1 of 2 treatment arms.
Treatment in both arms repeats every 21 days in the absence of disease progression or unacceptable toxicity. Patients with measurable disease achieving a clinical response (CR) receive 6-8 courses of therapy. Patients with stable disease or partial regression receive a maximum of 6 courses. Patients without measurable lesions as determined by a CT scan prior to initiating study treatment continue therapy for 6 courses or, if CA-125 normalizes, for 2 cycles beyond CA-125 normalization, whichever is greater. Patients in arm II then receive a maintenance regimen comprising bevacizumab IV over 30-90 minutes. Treatment with bevacizumab alone repeats every 3 weeks in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed periodically for 10 years.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Patients must have histologic diagnosis of ovarian epithelial carcinoma, primary peritoneal cavity carcinoma, or fallopian tube carcinoma
The following histologic epithelial cell types** are allowed:
Patients with synchronous primary endometrial cancer or a past history of primary endometrial cancer are excluded, unless all of the following conditions are met:
Patients must have had a complete response to front-line platinum-taxane therapy (at least 3 cycles) and a treatment-free interval without clinical evidence of progressive disease lasting at least 6 months
A complete response to front-line chemotherapy must include the following:
Front-line treatment may include maintenance therapy following complete clinical or pathological response provided recurrent disease is not identified earlier than 6 months following completion of all anticancer treatment
Clinically evident measurable or nonmeasurable disease*** defined as at least one lesion that can be accurately measured in at least one dimension (longest dimension to be recorded)
Patients with clinically evident measurable or nonmeasurable disease must also have any 1 of the following:
PATIENT CHARACTERISTICS:
Inclusion criteria:
Exclusion criteria:
Patients with clinically significant cardiovascular disease including any of the following:
PRIOR CONCURRENT THERAPY:
Contacts and Locations
Show 264 Study Locations| Study Chair: | Robert L. Coleman, MD | M.D. Anderson Cancer Center |
| Investigator: | Scott M. Eisenkop, MD, FACOG | Women's Cancer Center - Los Gatos |
| Investigator: | Deborah K. Armstrong, MD | Sidney Kimmel Comprehensive Cancer Center |
| Investigator: | Thomas J. Herzog, MD | Herbert Irving Comprehensive Cancer Center |
| Investigator: | Paul Sabbatini, MD | Memorial Sloan-Kettering Cancer Center |
More Information
| Responsible Party: | Philip J. DiSaia, Gynecologic Oncology Group |
| ClinicalTrials.gov Identifier: | NCT00565851 History of Changes |
| Other Study ID Numbers: | CDR0000546714, GOG-0213 |
| Study First Received: | November 29, 2007 |
| Last Updated: | April 2, 2011 |
| Health Authority: | Unspecified |
|
recurrent ovarian epithelial cancer peritoneal cavity cancer fallopian tube cancer ovarian serous cystadenocarcinoma ovarian endometrioid adenocarcinoma |
ovarian mucinous cystadenocarcinoma ovarian undifferentiated adenocarcinoma ovarian clear cell cystadenocarcinoma ovarian mixed epithelial carcinoma Brenner tumor |
|
Neoplasms Ovarian Neoplasms Peritoneal Neoplasms Fallopian Tube Neoplasms Neoplasms, Glandular and Epithelial 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 Neoplasms by Histologic Type Docetaxel Bevacizumab Carboplatin Paclitaxel Antineoplastic Agents Therapeutic Uses Pharmacologic Actions Tubulin Modulators Antimitotic Agents Mitosis Modulators |