Study:
A Phase III Clinical Trial of Bevacizumab With IV Versus IP Chemotherapy in Ovarian, Fallopian Tube, and Primary Peritoneal Carcinoma NCI-Supplied Agent(s): Bevacizumab (NSC #704865, IND #7921)
Rationale:
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. Drugs used in chemotherapy, such
as paclitaxel, carboplatin, and cisplatin, work in different ways to stop the growth of
tumor cells, either by killing the cells or by stopping them from dividing. It is not yet
known whether giving bevacizumab together with intravenous chemotherapy is more effective
than giving bevacizumab together with intraperitoneal chemotherapy in treating patients with
ovarian epithelial cancer, fallopian tube cancer, or primary peritoneal cancer.
Purpose:
This randomized phase III trial is studying bevacizumab and intravenous chemotherapy to see
how well they work compared with bevacizumab and intraperitoneal chemotherapy in treating
patients with stage II, stage III, or stage IV ovarian epithelial cancer, fallopian tube
cancer, or primary peritoneal cancer. 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. Drugs
used in chemotherapy, such as paclitaxel, carboplatin, and cisplatin, work in different ways
to stop the growth of tumor cells, either by killing the cells or by stopping them from
dividing. It is not yet known whether giving bevacizumab together with intravenous
chemotherapy is more effective than giving bevacizumab together with intraperitoneal
chemotherapy in treating patients with ovarian epithelial cancer, fallopian tube cancer, or
primary peritoneal cancer
Study Status: Active, not recruiting
Recruiting:
n/a
| Condition |
Intervention |
Phase |
Brenner Tumor
Ovarian Clear Cell Cystadenocarcinoma
Ovarian Endometrioid Adenocarcinoma
Ovarian Mixed Epithelial Carcinoma
Ovarian Mucinous Cystadenocarcinoma
Ovarian Serous Cystadenocarcinoma
Ovarian Undifferentiated Adenocarcinoma
Stage IIA Fallopian Tube Cancer
Stage IIA Ovarian Epithelial Cancer
Stage IIA Primary Peritoneal Cavity Cancer
Stage IIB Fallopian Tube Cancer
Stage IIB Ovarian Epithelial Cancer
Stage IIB Primary Peritoneal Cavity Cancer
Stage IIC Fallopian Tube Cancer
Stage IIC Ovarian Epithelial Cancer
Stage IIC Primary Peritoneal Cavity Cancer
Stage IIIA Fallopian Tube Cancer
Stage IIIA Ovarian Epithelial Cancer
Stage IIIA Primary Peritoneal Cavity Cancer
Stage IIIB Fallopian Tube Cancer
Stage IIIB Ovarian Epithelial Cancer
Stage IIIB Primary Peritoneal Cavity Cancer
Stage IIIC Fallopian Tube Cancer
Stage IIIC Ovarian Epithelial Cancer
Stage IIIC Primary Peritoneal Cavity Cancer
Stage IV Fallopian Tube Cancer
Stage IV Ovarian Epithelial Cancer
Stage IV Primary Peritoneal Cavity Cancer |
Drug: paclitaxel
Drug: carboplatin
Biological: bevacizumab
Drug: cisplatin
Drug: carboplatin
Drug: paclitaxel
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: NCT00951496
Study Type: Interventional
Study Design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Cleveland Clinic Cancer Center/Fairview Hospital
Cleveland, Ohio 44111
United States
Cleveland Clinic Foundation
Cleveland, Ohio 44195
United States
Joan Walker., Principal Investigator