Purpose:
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing
so they stop growing or die.
PURPOSE: Phase II trial to study the effectiveness of etoposide in treating patients who
have refractory, recurrent, or metastatic ovarian or cervical cancer.
Study summary:
OBJECTIVES: I. Determine the efficacy of prolonged oral etoposide (VP-16) in patients with
advanced ovarian epithelial or cervical cancer. II. Evaluate the frequency and severity of
observed adverse effects in this patient population treated with prolonged oral VP-16.
OUTLINE: Patients receive etoposide by mouth once daily on days 1-21 every 4 weeks. Patients
with responding disease continue treatment for up to 12 months in the absence of disease
progression or unacceptable toxicity. Patients with stable disease continue treatment for up
to 6 months in the absence of disease progression or unacceptable toxicity.
PROJECTED ACCRUAL: If 4-6 responses are observed in the first 25 patients, an additional 15
patients will be entered. The estimated duration of the study is 8 months.
Criteria:
DISEASE CHARACTERISTICS: Histologically confirmed recurrent or metastatic ovarian
epithelial or cervical cancer Tissue not accessible for biopsy Refractory to curative
therapy or established treatments and ineligible for higher priority GOG protocols
Measurable disease required, as follows: Lesion measurable by physical exam Lesion
bidimensionally measurable on sonogram or imaging Ascites/pleural effusion not measurable
PATIENT CHARACTERISTICS: Age: Any age Performance status: GOG 0-2 Hematopoietic: WBC at
least 3,000/mm3 Absolute granulocyte count at least 1,500/mm3 Platelets at least
100,000/mm3 Hepatic: Bilirubin no more than 1.5 times normal AST no more than 3 times
normal Alkaline phosphatase no more than 3 times normal Renal: Creatinine no greater than
2.0 mg/dL Other: Body surface area at least 1 square meter No requirement for intravenous
hydration or nutritional support No significant infection No second malignancy other than
nonmelanomatous skin cancer
PRIOR CONCURRENT THERAPY: Biologic therapy: At least 3 weeks since anticancer therapy
Chemotherapy: No more than 1 prior chemotherapy trial No prior etoposide At least 3 weeks
since chemotherapy and recovered Endocrine therapy: At least 3 weeks since anticancer
therapy Radiotherapy: At least 3 weeks since radiotherapy Surgery: At least 3 weeks since
surgery and recovered