Karenitecin in Treating Patients With Persistent or Recurrent Ovarian Epithelial Cancer or Primary Peritoneal Cancer

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