Study:
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
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. 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
Study Status: Active, not recruiting
Recruiting:
n/a
| Condition |
Intervention |
Phase |
Brenner Tumor
Fallopian Tube Cancer
Ovarian Clear Cell Cystadenocarcinoma
Ovarian Endometrioid Adenocarcinoma
Ovarian Mixed Epithelial Carcinoma
Ovarian Mucinous Cystadenocarcinoma
Ovarian Serous Cystadenocarcinoma
Ovarian Undifferentiated Adenocarcinoma
Primary Peritoneal Cavity Cancer
Stage III Ovarian Epithelial Cancer
Stage IV Ovarian Epithelial Cancer |
Other: hydrocortisone/placebo
Drug: paclitaxel
Drug: carboplatin
Biological: bevacizumab |
Phase 3 |
Verified by
National Cancer Institute (NCI)
September, 2012
Sponsored by: National Cancer Institute (NCI)
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov identifier: NCT00262847
Study Type: Interventional
Study Design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
Cleveland Clinic Foundation
Cleveland, Ohio 44195
United States
Robert Burger., Principal Investigator