Conditions: Ovarian Cancer Primary Peritoneal Carcinoma Fallopian Tube Cancer Mixed Tumor, Mesodermal
Keywords: carboplatin paclitaxel elderly women
Allocation: NA | Intervention model: SINGLE_GROUP
Enrollment: 12
Healthy volunteers: no

Brief summary:
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.

Detailed description:
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.

Arms:
arm 1: 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.

Interventions: intervention 1: Paclitaxel intervention 2: Carboplatin
Intervention descriptions: intervention 1: None intervention 2: None

Protocol document: