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.

Inclusion Criteria:

- Age 70 or older

- Eastern Cooperative Oncology Group (ECOG) performance status of 0,1 or 2 and is
medically eligible and clinically appropriate to receive systemic chemotherapy

- Diagnosis of ovarian, primary peritoneal, fallopian tube cancer, papillary serous
cancer of the endometrium, or mixed mesodermal tumors of the ovary, fallopian tube or
uterus

- Life expectancy greater than 6 months

- Baseline laboratory values as described in protocol

Exclusion Criteria:

- Active infection requiring antibiotics at the time of starting chemotherapy

- Prior pelvic radiotherapy > 25% of bone marrow

- Any uncontrolled medical problem that in the opinion of the investigator would
preclude safe administration of the study drugs

- Past history of bone marrow transplantation or stem cell support

- Known history of central nervous system (CNS) metastasis

- History of prior malignancy that required prior systemic therapy

- Clinically significant cardiac disease

- Uncontrolled diabetes mellitus

- Any signs of intestinal obstruction

- Participation in an investigational drug study within three weeks prior to study entry

- History of psychiatric disability or other central nervous system disorder