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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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A Phase II Evaluation of Karenitecin in the Third-Line Treatment of Persistent or Recurrent Epithelial Ovarian or Primary Peritoneal Carcinoma

Conditions
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Primary Peritoneal Carcinoma, Recurrent Ovarian Carcinoma

Intervention / Treatment
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* Drug: Cositecan
* Other: Pharmacological Study


Participation Criteria
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Eligibility Criteria
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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
Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Treatment<br>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. | Drug: Cositecan<br>* Given IV<br>* Other names: Karenitecin;Other: Pharmacological Study<br>* Correlative studies<br>* Other names: pharmacological studies;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Frequency of objective response |  | Up to 6 years | 
| Duration of objective response |  | Up to 6 years | 
| Frequency of observed adverse effects, graded according to CTC version 2.0 |  | Up to 6 years | 
| Severity of observed adverse effects, graded according to CTC version 2.0 |  | Up to 6 years | 
| Survival time for all patients |  | Up to 6 years | 
| Duration of progression-free interval for all patients |  | Up to 6 years |