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

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.