A GCIG Intergroup Multicenter Phase III Trial of Open Label Carboplatin and Paclitaxel +/- NCI-Supplied Agent: Bevacizumab (NSC #704865, IND #7921) Compared With Oxaliplatin and Capecitabine +/- Bevacizumab as First Line Chemotherapy in Patients With Mucinous Epithelial Ovarian Cancer or Fallopian Tube Cancer (MEOC)

Status
Active
Cancer Type
Ovarian Cancer
Trial Phase
Phase III
Eligibility
18 and over, Female
Study Type
Health services research
Treatment
NCD ID
NCT01081262
Protocol IDs
NCI-2011-02516 (primary)
GOG-0241
U10CA027469
CDR0000667089
UCL-07/095
UCL-mEOC
ISRCTN83438782
EUDRACT-2008-000837-23
EU-21007
NCRI-UCL-07/095
CRUK-UCL-07/095
Study Sponsor
National Cancer Institute

Summary

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

Objectives

PRIMARY OBJECTIVES:

I. To determine whether carboplatin and paclitaxel with versus without bevacizumab compared to oxaliplatin and capecitabine with versus without bevacizumab as first-line therapy improves the survival of patients with newly diagnosed stage II-IV or recurrent stage I mucinous epithelial ovarian or fallopian tube cancer.

II. To determine whether the addition of bevacizumab to chemotherapy improves the overall survival of these patients.

SECONDARY:

I. To compare progression-free survival of patients treated with these regimens.

II. To compare the response rate in patients treated with these regimens. III. To compare the toxicity of these regimens in these patients. IV. To compare quality of life of patients treated with these regimens. V. To examine the financial costs of these treatments in relation to clinical benefit.

OUTLINE: This is a multicenter study. Patients are stratified according to disease status (no gross residual disease [i.e., 0] vs residual disease [> 0]), disease stage (recurrent stage I [chemonaive] vs stage II-IV), and country (U.S. vs non-U.S.). Patients are randomized to 1 of 4 treatment arms.

ARM I: Patients receive carboplatin IV over 30-60 minutes on day 1 and paclitaxel IV over 3 hours on day 1. Treatment repeats every 3 weeks for 6 courses in the absence of disease progression or unacceptable toxicity.

ARM II: Patients receive oxaliplatin IV over 2-6 hours on day 1 and oral capecitabine twice a day on days 1-14. Treatment repeats every 3 weeks for 6 courses in the absence of disease progression or unacceptable toxicity.

ARM III: Patients receive carboplatin and paclitaxel IV as in arm I and bevacizumab IV over 30-90 minutes on day 1. Treatment repeats every 3 weeks for 6 courses in the absence of disease progression or unacceptable toxicity. Patients then receive bevacizumab IV over 30-90 minutes alone on day 1. Treatment repeats every 3 weeks for 12 courses in the absence of disease progression or unacceptable toxicity.

ARM IV: Patients receive oxaliplatin and capecitabine as in arm II, and bevacizumab as in arm III.

Patients complete quality-of-life questionnaires (FACT-O TOI, FACT/GOG-NTX Subscale, and EQ-5D) at baseline, during study treatment, and after completion of study treatment.

After completion of study treatment, patients are followed at 4-6 weeks, every 3 months for 2 years, and then every 6 months for 3-5 years.

Peer Reviewed and Funded or Endorsed by Cancer Research UK