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

• Status: Completed
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: Female

Summary

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Gynecologic Oncology Group
• Collaborator: National Cancer Institute (NCI)
• Treatments: Camptothecin

Criteria

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