Primary Peritoneal Carcinoma, Recurrent Ovarian Carcinoma
Conditions
Brief 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.
Detailed description
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.
Interventions
DRUGCositecan
Given IV
OTHERPharmacological Study
Correlative studies
Sponsors
National Cancer Institute (NCI)
Gynecologic Oncology Group
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | 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 |
Countries
United States
Outcome results
None listed