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 DX-8951f in treating patients who have
recurrent, metastatic, or unresectable ovarian, fallopian tube, or peritoneal cancer.
OBJECTIVES: I. Determine the antitumor activity of DX-8951f in patients with recurrent,
metastatic, or unresectable ovarian, tubal, or peritoneal carcinoma that is refractory to
platinum, taxane, and topotecan. II. Evaluate the quantitative and qualitative toxic effects
of this regimen in these patients. III. Evaluate the pharmacokinetics of this regimen in
OUTLINE: Patients are stratified by prior chemotherapy (minimally pretreated vs heavily
pretreated). Patients receive intravenous DX-8951f over 30 minutes daily for 5 days. Courses
repeat every 21 days in the absence of disease progression or unacceptable toxicity.
Patients are followed every 3 months until death.
PROJECTED ACCRUAL: Approximately 37 patients will be accrued for this study.
DISEASE CHARACTERISTICS: Histologically confirmed recurrent, metastatic, or unresectable
ovarian, tubal, or peritoneal carcinoma that is refractory to platinum, taxane, and
topotecan Must have received at least 1 prior chemotherapy regimen Resistance to platinum,
taxane, and topotecan is defined as the following: Progressive disease while on
chemotherapy OR Relapse within six months of completing chemotherapy OR Failure to achieve
complete response after six courses of chemotherapy No recurrent or metastatic disease
amenable to attempted curative therapy with surgery and/or radiotherapy Measurable disease
No brain metastases
PATIENT CHARACTERISTICS: Age: 18 and over Performance status: ECOG 0-2 Life expectancy: At
least 12 weeks Hematopoietic: Absolute neutrophil count at least 1,500/mm3 Platelet count
at least 100,000/mm3 Hepatic: Bilirubin no greater than 1.5 mg/dL SGOT or SGPT no greater
than 2 times upper limit of normal (ULN) (5 times ULN if liver metastases present) Renal:
Creatinine no greater than 1.5 mg/dL Cardiovascular: No active congestive heart failure No
uncontrolled angina No myocardial infarction within past 6 months Other: Not pregnant or
nursing Negative pregnancy test Fertile patients must use effective contraception No
concurrent serious infection No psychiatric disorder or mental disability No other
malignancy within past 5 years, except: Nonmelanomatous skin cancer Carcinoma in situ of
the cervix No other life threatening illness No history of camptothecin derivative allergy
PRIOR CONCURRENT THERAPY: Biologic therapy: No concurrent biologic therapy Chemotherapy:
See Disease Characteristics At least 4 weeks since prior chemotherapy (6 weeks for
nitrosoureas or mitomycin) No other concurrent chemotherapy Endocrine therapy: Not
specified Radiotherapy: See Disease Characteristics At least 4 weeks since prior
radiotherapy No concurrent radiotherapy Surgery: See Disease Characteristics At least 4
weeks since prior surgery No concurrent surgery Other: At least 4 weeks since other prior
investigational drugs No other concurrent investigational drugs and for 4 weeks after