Carboplatin and Paclitaxel in Elderly Women With Newly Diagnosed Ovarian, Peritoneal, or Fallopian Cancer
Primary Peritoneal Carcinoma
Fallopian Tube Cancer
Mixed Tumor, Mesodermal
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Phase II Study of Carboplatin and Paclitaxel in Elderly Women With Newly Diagnosed Ovarian, Peritoneal, or Fallopian Cancer|
- Therapy Completion Rate [ Time Frame: 6 cycles of therapy, up to approximately 4.5 months given the cycle length of 21 days. ] [ Designated as safety issue: Yes ]The therapy completion rate is the proportion of patients who completed 6 cycles of carboplatin/paclitaxel therapy without dose reductions.
|Study Start Date:||April 2006|
|Study Completion Date:||April 2010|
|Primary Completion Date:||April 2008 (Final data collection date for primary outcome measure)|
Patients received chemotherapy on day 1 of a 21 day cycle for 6 cycles. Paclitaxel was given via peripheral or central IV catheter at the dose of 175 mg/m2 over 3 hours. IV carboplatin followed using a dose of Area Under the Curve (AUC) equal to 5 with creatinine clearance based on Jelliffe formula.
Other Name: TaxolDrug: Carboplatin
•To determine the completion rate of six cycles of carboplatin/paclitaxel with no dose reductions because of toxicities.
- 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.
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00322881
|United States, Massachusetts|
|Massachusetts General Hospital|
|Boston, Massachusetts, United States, 02114|
|Dana-Farber Cancer Institute|
|Boston, Massachusetts, United States, 02155|
|Principal Investigator:||Ursula Matulonis, MD||Dana-Farber Cancer Institute|