Ovarian Cancer Clinical Trial
Official title:
A Phase II Study of 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.
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.
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