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Carboplatin and Paclitaxel or Oxaliplatin and Capecitabine, With or Without Bevacizumab, as First-Line Therapy in Treating Patients With Newly Diagnosed Stage II, Stage III, Stage IV, or Recurrent Stage I Epithelial Ovarian Cancer or Fallopian Tube Cancer

Study:

A GCIG Intergroup Multicenter Phase III Trial of Open Label Carboplatin and Paclitaxel +/- NCI-Supplied Agent: Bevacizumab (NSC #704865, IND #113912) Compared With Oxaliplatin and Capecitabine +/- Bevacizumab as First Line Chemotherapy in Patients With Mucinous Epithelial Ovarian Cancer or Fallopian Tube Cancer (MEOC)

Rationale:

n/a

Purpose:

This randomized phase III trial is studying carboplatin given together with paclitaxel with or without bevacizumab to see how well it works compared with oxaliplatin given together with capecitabine with or without bevacizumab as first-line therapy in treating patients with newly diagnosed stage II, stage III, stage IV, or recurrent stage I epithelial ovarian cancer or fallopian tube cancer. Drugs used in chemotherapy, such as carboplatin, paclitaxel, oxaliplatin, and capecitabine, 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 which regimen of combination chemotherapy given together with or without bevacizumab is more effective in treating epithelial ovarian cancer or fallopian tube cancer.

Study Status: Recruiting

Recruiting:
Peter G. Rose 866-223-8100

Peter G. Rose 866-223-8100

Condition Intervention Phase
Ovarian Mucinous Cystadenocarcinoma
Ovarian Mucinous Cystadenoma With Proliferating Activity
Recurrent Fallopian Tube Cancer
Recurrent Ovarian Epithelial Cancer
Stage IA Fallopian Tube Cancer
Stage IA Ovarian Epithelial Cancer
Stage IB Fallopian Tube Cancer
Stage IB Ovarian Epithelial Cancer
Stage IC Fallopian Tube Cancer
Stage IC Ovarian Epithelial Cancer
Stage IIA Fallopian Tube Cancer
Stage IIA Ovarian Epithelial Cancer
Stage IIB Fallopian Tube Cancer
Stage IIB Ovarian Epithelial Cancer
Stage IIC Fallopian Tube Cancer
Stage IIC Ovarian Epithelial Cancer
Stage IIIA Fallopian Tube Cancer
Stage IIIA Ovarian Epithelial Cancer
Stage IIIB Fallopian Tube Cancer
Stage IIIB Ovarian Epithelial Cancer
Stage IIIC Fallopian Tube Cancer
Stage IIIC Ovarian Epithelial Cancer
Stage IV Fallopian Tube Cancer
Stage IV Ovarian Epithelial Cancer
Procedure: quality-of-life assessment
Drug: carboplatin
Drug: paclitaxel
Drug: oxaliplatin
Drug: capecitabine
Biological: bevacizumab
Phase 3

Verified by National Cancer Institute (NCI) December, 2013

Sponsored by: National Cancer Institute (NCI)
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov identifier: NCT01081262

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

David Gershenson., 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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