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Carboplatin, Paclitaxel and Gemcitabine With or Without Bevacizumab After Surgery in Treating Patients With Recurrent Ovarian Epithelial Cancer, Primary Peritoneal Cavity Cancer, or Fallopian Tube Cancer

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) August, 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 Cancer Center/Fairview Hospital
Cleveland, Ohio 44111
United States

Cleveland Clinic Foundation
Cleveland, Ohio 44195
United States

Robert Coleman., Principal Investigator

This information is abridged to display results relevant only to Cleveland Clinic. To see complete record visit ClinicalTrials.gov
  Information obtained from ClinicalTrials.gov on
Link to the current ClinicalTrials.gov record.

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