Carboplatin and Paclitaxel in Elderly Women With Newly Diagnosed Ovarian, Peritoneal, or Fallopian Cancer
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|ClinicalTrials.gov Identifier: NCT00322881|
Recruitment Status : Terminated (Early closure based on audit by study investigators after 3 patients died on study.)
First Posted : May 8, 2006
Results First Posted : June 17, 2015
Last Update Posted : September 10, 2018
|Condition or disease||Intervention/treatment||Phase|
|Ovarian Cancer Primary Peritoneal Carcinoma Fallopian Tube Cancer Mixed Tumor, Mesodermal||Drug: Paclitaxel Drug: Carboplatin||Phase 2|
•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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||12 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase II Study of Carboplatin and Paclitaxel in Elderly Women With Newly Diagnosed Ovarian, Peritoneal, or Fallopian Cancer|
|Study Start Date :||April 2006|
|Actual Primary Completion Date :||April 2008|
|Actual Study Completion Date :||April 2010|
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: Taxol
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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|