Clinical Trial: Carboplatin and Paclitaxel in Elderly Women With Newly Diagnosed Ovarian, Peritoneal, or Fallopian Cancer

Study Status: Terminated
Recruit Status: Terminated
Study Type: Interventional

Official Title: A Phase II Study of Carboplatin and Paclitaxel in Elderly Women With Newly Diagnosed Ovarian, Peritoneal, or Fallopian Cancer

Brief Summary: The main purpose of this trial is to look at how elderly women (70 years of age or older) with newly diagnosed ovarian, peritoneal, or fallopian tube cancer manage six cycles of carboplatin and paclitaxel, what side effects they experience, and how their cancer reacts or responds to standard carboplatin and paclitaxel chemotherapy.

Detailed Summary:

OBJECTIVES:

Primary

•To determine the completion rate of six cycles of carboplatin/paclitaxel with no dose reductions because of toxicities.

Secondary

  • Assess cancer antigen 125 (CA125) response rates of paclitaxel/carboplatin in this group of patients
  • Assess significant toxicities in this group of patients and compare to a non-elderly population.
  • To determine which clinical parameters will predict lack of completion of six cycles of carboplatin and paclitaxel chemotherapy.
  • Assess quality of life changes during chemotherapy and up to one year after completion of chemotherapy.
  • Assess progression-free survival and overall survival for this group.
  • To determine the feasibility of accrual.

STATISTICAL DESIGN:

Using a one sample binomial design, with 37 patients there was 83% power to detect a null hypothesis of a 45% therapy completion rate versus an alternative hypothesis of a 66% rate assuming a one-sided 5% alpha. The regimen would be declared ineffective if there were 19 or fewer patients who completed 6 cycles of carboplatin and paclitaxel chemotherapy without dose adjustments.


Sponsor: Dana-Farber Cancer Institute

Current Primary Outcome: Therapy Completion Rate [ Time Frame: 6 cycles of therapy, up to approximately 4.5 months given the cycle length of 21 days. ]

The therapy completion rate is the proportion of patients who completed 6 cycles of carboplatin/paclitaxel therapy without dose reductions.


Original Primary Outcome: To determine the completion rate of six cycles of carboplatin/paclitaxel in this elderly population with no dose reductions because of toxicities.

Current Secondary Outcome:

Original Secondary Outcome:

  • Assess CA125 response rates in this group of patients
  • Assess significant toxicities in this group of patients and compare to a non-elderly population
  • Assess quality of life changes during chemotherapy
  • Assess overall survival for this group of patients.


Information By: Dana-Farber Cancer Institute

Dates:
Date Received: May 5, 2006
Date Started: April 2006
Date Completion:
Last Updated: March 22, 2017
Last Verified: March 2017