Carboplatin and Paclitaxel in Elderly Women With Newly Diagnosed Ovarian, Peritoneal, or Fallopian Cancer
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.
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|
|Dana-Farber Cancer Institute|
|Boston, Massachusetts, United States, 02155|
|Massachusetts General Hospital|
|Boston, Massachusetts, United States, 02114|
|Principal Investigator:||Ursula Matulonis, MD||Dana-Farber Cancer Institute|