NCT00322881

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

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

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 12 (actual)
• Sponsor: Dana-Farber Cancer Institute · Academic / Other
• Sex: Female
• Age: 70 Years
• Healthy volunteers: Not accepted

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 description

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.

Conditions

• Ovarian Cancer
• Primary Peritoneal Carcinoma
• Fallopian Tube Cancer
• Mixed Tumor, Mesodermal

Interventions

Type	Name	Description
DRUG	Paclitaxel
DRUG	Carboplatin

Timeline

• Start date: 2006-04-01
• Primary completion: 2008-04-01
• Completion: 2010-04-01
• First posted: 2006-05-08
• Last updated: 2018-09-10
• Results posted: 2015-06-17

Locations

2 sites across 1 country: United States