Expired Study
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Phoenix, Arizona 85012


Purpose:

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.


Study summary:

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.


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


NCT ID:

NCT00054119


Primary Contact:

Principal Investigator
John Kavanagh
Gynecologic Oncology Group


Backup Contact:

N/A


Location Contact:

Phoenix, Arizona 85012
United States



There is no listed contact information for this specific location.

Site Status: N/A


Data Source: ClinicalTrials.gov

Date Processed: December 12, 2017

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