Study:
A Phase III Randomized Controlled Clinical Trial of Carboplatin and Paclitaxel (or Gemcitabine) Alone or in Combination With Bevacizumab (NSC #704865, IND #113912) Followed by Bevacizumab and Secondary Cytoreductive Surgery in Platinum-Sensitive, Recurrent Ovarian, Peritoneal Primary and Fallopian Tube Cancer. NCI-Supplied Agents: Bevacizumab (NSC #704865, IND #113912)
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, paclitaxel and gemcitabine
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. Drugs used in chemotherapy, such as carboplatin, paclitaxel and
gemcitabine 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
Study Status: Recruiting
Recruiting:
Peter G. Rose 866-223-8100
Peter G. Rose 866-223-8100
| 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
Recurrent Ovarian Epithelial Cancer |
Drug: paclitaxel
Drug: docetaxel
Drug: carboplatin
Biological: bevacizumab
Drug: gemcitabine hydrochloride
Other: laboratory biomarker analysis
Procedure: quality-of-life assessment |
Phase 3 |
Verified by
National Cancer Institute (NCI)
March, 2013
Sponsored by: National Cancer Institute (NCI)
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov identifier: NCT00565851
Study Type: Interventional
Study Design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Cleveland Clinic Foundation
Cleveland, Ohio 44195
United States
Cleveland Clinic Cancer Center/Fairview Hospital
Cleveland, Ohio 44111
United States
Robert Coleman., Principal Investigator