Clinical Trial: Paclitaxel and Carboplatin With or Without Bevacizumab in Treating Patients With Stage II, Stage III, or Stage IV Ovarian Epithelial Cancer, Primary Peritoneal Cancer, or Fallopian Tube Cancer

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

Official Title: A Phase III Trial of Every-3-Weeks Paclitaxel Versus Dose Dense Weekly Paclitaxel in Combination With Carboplatin With or Without Concurrent and Consolidation Bevacizumab (NSC #704865) in the Treatmen

Brief Summary: This phase III clinical trial studies two different dose schedules of paclitaxel to see how well they work in combination with carboplatin with or without bevacizumab in treating patients with stage II, III or IV ovarian epithelial cancer, primary peritoneal cancer, or fallopian tube cancer. Drugs used in chemotherapy, such as paclitaxel and carboplatin, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Bevacizumab is a type of drug called a monoclonal antibody and blocks tumor growth by stopping the growth of blood vessels that tumors need to grow. It is not yet known whether giving paclitaxel with combination chemotherapy once every three weeks is more effective than giving paclitaxel once a week in treating patients with ovarian, primary peritoneal, or fallopian tube cancer.

Detailed Summary:

PRIMARY OBJECTIVES:

I. To determine if the weekly paclitaxel regimen increases the time until first progression or death (progression-free survival [PFS]) compared to the every-3-week paclitaxel regimen in women with primary stage II, III or IV epithelial ovarian, peritoneal or fallopian tube cancer who are receiving carboplatin with or without bevacizumab.

SECONDARY OBJECTIVES:

I. To determine if the weekly paclitaxel increases the duration of overall survival compared to the every-3-week paclitaxel when combined with carboplatin with or without bevacizumab.

II. To compare the weekly paclitaxel to the every-3-week paclitaxel with respect to the incidence of severe or serious adverse events when it is combined with carboplatin with or without bevacizumab.

III. To compare the weekly paclitaxel to the every-3-week paclitaxel with respect to patients' self-reported quality of life (QOL) as measured by the Functional Assessment of Cancer Therapy-Ovarian (FACT-O)-Trial Outcome Index (TOI), when paclitaxel is combined with carboplatin with or without bevacizumab. (As of 02/08/2012, the QOL portion of this study is complete; patients enrolled after this date will not have QOL assessments)

TERTIARY OBJECTIVES:

I. To evaluate single nucleotide polymorphisms (SNPs) associated with progression-free survival and toxicity in advanced stage epithelial ovarian, peritoneal and fallopian tube cancer using genome wide association studies (GWAS).* II. To evaluate genomic signatures in tumor tissues which are predictive for patient survival in advanced stage epithelial ovarian, peritoneal and fall
Sponsor: National Cancer Institute (NCI)

Current Primary Outcome: Progression-free survival [ Time Frame: Time from study entry to time of progression or death, whichever occurs first, assessed up to 5 years ]

Original Primary Outcome: Progression-free survival

Current Secondary Outcome:

  • Incidence of adverse effects using the National Cancer Institute CTCAE version 4.0 [ Time Frame: Up to 5 years ]
    Safety endpoints will be summarized with descriptive statistics for the patients in the safety analysis dataset.
  • Overall survival [ Time Frame: From study entry to time of death or the date of last contact, assessed up to 5 years ]
  • QOL assessed using the FACT-O TOI (as of 02/08/2012, the QOL portion of this study is complete; patients enrolled after this date will not have QOL assessments) [ Time Frame: Up to 63 weeks ]
    Will be assessed with a mixed model, adjusting for pretreatment TOI score, age and bevacizumab option.
  • Response rate according to RECIST [ Time Frame: Up to 5 years ]


Original Secondary Outcome:

  • Overall survival
  • Response rate
  • Toxicity
  • Translational research
  • Quality of life


Information By: National Cancer Institute (NCI)

Dates:
Date Received: July 21, 2010
Date Started: September 2010
Date Completion:
Last Updated: December 21, 2015
Last Verified: December 2015