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

Study Status: Active, not recruiting
Recruit Status: Active, not recruiting
Study Type: Interventional

Official Title: A GCIG Intergroup Multicenter Phase III Trial of Open Label Carboplatin and Paclitaxel +/- NCI-Supplied Agent: Bevacizumab (NSC #704865) Compared With Oxaliplatin and Capecitabine +/- Bevacizumab as F

Brief Summary: This randomized phase III trial studies 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-IV, or recurrent (has come back) stage I epithelial ovarian 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, may block tumor growth in different ways by targeting certain cells. 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.

Detailed Summary:

PRIMARY OBJECTIVES:

I. To determine if capecitabine and oxaliplatin reduces the death rate compared to carboplatin and paclitaxel in women with mucinous adenocarcinoma of the ovary or fallopian tube.

II. To determine if bevacizumab reduces the death rate compared to no bevacizumab in women with mucinous adenocarcinoma of the ovary or fallopian tube.

SECONDARY OBJECTIVES:

I. To determine if capecitabine and oxaliplatin increases the duration of progression-free survival (PFS) compared to carboplatin and paclitaxel in women with mucinous adenocarcinoma of the ovary or fallopian tube.

II. To determine if bevacizumab increases the duration of PFS compared to no bevacizumab in women with mucinous adenocarcinoma of the ovary or fallopian tube.

III. To compare the response rates for capecitabine and oxaliplatin versus carboplatin and paclitaxel in patients with mucinous adenocarcinoma of the ovary or fallopian tube with measurable disease after initial tumor reductive surgery.

IV. To compare the response rates for bevacizumab versus no bevacizumab in patients with mucinous adenocarcinoma of the ovary or fallopian tube with measurable disease after initial tumor reductive surgery.

V. To determine the nature and degree of toxicity of capecitabine and oxaliplatin compared with that of carboplatin and paclitaxel in this cohort of patients.

VI. To determine the nature and degree of toxicity of bevacizumab in this cohort of patients.

VII. To c
Sponsor: National Cancer Institute (NCI)

Current Primary Outcome: Overall survival [ Time Frame: Up to 7 years ]

Examined using Kaplan-Meier curves. The main effect size will be quantified by the hazard ratio and 95% confidence interval. Multivariate regression will also be used to examine whether there is an interaction between oxaliplatin + capecitabine and bevacizumab.


Original Primary Outcome: Overall survival

Current Secondary Outcome:

  • Incidence of adverse effects assessed by CTCAE version 4.0 [ Time Frame: Up to 7 years ]
    Toxicity grades will be tabulated showing the maximum toxicity grade experienced by each patient. The proportions of patients experiencing a maximum grade of 3 or above will be compared between the treatment groups.
  • Progression-free survival [ Time Frame: Up to 7 years ]
    Examined using Kaplan-Meier curves. The main effect size will be quantified by the hazard ratio and 95% confidence interval. Multivariate regression will also be used to examine whether there is an interaction between oxaliplatin + capecitabine and bevacizumab.
  • QOL scores assessed using FACT-O TOI and FACT-GOG/Neurotoxicity 4 [ Time Frame: Up to 60 months ]
    Analysis of the QOL data will use the observed scores at each time point, where available. For simplicity, the change from baseline to each of time points will be examined. However, the main analysis will be a repeated measures analysis (for example, based on a mixed model, Proc Mixed in SAS) used to simultaneously compare all QOL scores between the two treatment groups.
  • Response rates assessed by RECIST 1.1 [ Time Frame: Up to 7 years ]
    The comparison of response rates (proportion of patients with complete and partial response, stable and progressive disease) between treatment groups, will use a chi-square test. The difference in response rates between the groups and the odds ratio (with corresponding 95% confidence intervals) will also be calculated.


Original Secondary Outcome:

  • Progression-free survival
  • Response rate
  • Toxicity
  • Quality of life


Information By: National Cancer Institute (NCI)

Dates:
Date Received: March 4, 2010
Date Started: October 2010
Date Completion:
Last Updated: May 11, 2017
Last Verified: May 2017