Phase II trial to study the effectiveness of karenitecin in treating patients who have persistent or recurrent ovarian epithelial cancer or primary peritoneal cancer that has not responded to platinum-based treatment. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die.

OBJECTIVES:

I. Determine the antitumor activity of karenitecin in patients with persistent or recurrent platinum-resistant ovarian epithelial or primary peritoneal cancer.

II. Determine the toxicity of this drug in these patients.

OUTLINE: This is an open-label study.

Patients receive karenitecin IV over 1 hour on days 1-5. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.

Patients are followed every 3 months for 2 years, every 6 months for 3 years, and then annually thereafter.

Inclusion Criteria:

• Histologically confirmed ovarian epithelial or primary peritoneal cancer

  • Recurrent or persistent disease
  • Platinum-resistant disease

• At least 1 unidimensionally measurable lesion

  • At least 20 mm by conventional techniques OR at least 10 mm by spiral CT scan

• At least 1 target lesion to assess response (tumors within a previously irradiated field are designated as non-target)

• Ineligible for a higher priority GOG study or other phase II cytotoxic study for platinum-resistant disease

• Performance status - GOG 0-2

• Absolute neutrophil count at least 1,500/mm^3

• Platelet count at least 100,000/mm^3

• Bilirubin no greater than 1.5 times upper limit of normal (ULN)

• ALT no greater than 2.5 times ULN

• Alkaline phosphatase no greater than 2.5 times ULN

• Creatinine no greater than 1.5 times ULN

• No myocardial infarction within the past 6 months

• No cerebrovascular accident within the past 6 months

• No transient ischemic attack within the past 6 months

• No uncontrolled hypertension

• No decompensated or uncontrolled chronic heart failure

• Not pregnant or nursing

• Negative pregnancy test

• Fertile patients must use effective contraception

• No neuropathy (sensory or motor) grade 2 or greater

• No other invasive malignancies within the past 5 years except nonmelanoma skin cancer

• No active infection requiring antibiotics

• At least 3 weeks since prior biological or immunological agents

• See Disease Characteristics

• At least 3 weeks since prior chemotherapy and recovered

• No more than 2 prior cytotoxic chemotherapy regimens, with no more than 1 non-platinum, non-taxane regimen

• No prior karenitecin or camptothecin analogue/derivative

• At least 1 week since prior hormonal therapy

  • Concurrent hormone replacement therapy allowed

• See Disease Characteristics

• At least 3 weeks since prior radiotherapy and recovered

• No prior radiotherapy to more than 25% of marrow-bearing areas

• Recovered from recent surgery

• At least 3 weeks since prior therapy directed at this malignancy

• No prior anticancer therapy that would preclude study therapy

• No concurrent amifostine or other protective reagents