Expired Study
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Bronx, New York 10461


Purpose:

RATIONALE: Drugs used in chemotherapy, such as ixabepilone, work in different ways to stop tumor cells from dividing so they stop growing or die. PURPOSE: Phase II trial to study the effectiveness of ixabepilone in treating patients who have relapsed and/or refractory stage III or stage IV ovarian epithelial cancer or primary peritoneal cancer.


Study summary:

OBJECTIVES: Primary - Determine the antitumor activity of ixabepilone, in terms of clinical response and progression-free survival, in patients with relapsed and/or refractory stage III or IV ovarian epithelial or primary peritoneal cancer. - Determine the nature and degree of toxicity of this drug in these patients. Secondary - Correlate pre-ixabepilone survivin mRNA and protein levels in patient-derived ovarian cancer cells with quality of response (i.e., at least partial response vs no response). - Correlate CYP3A4 (3A4*1B), 3A5 (3A5*1), and 3A7 (ER6 p variation) allelic polymorphisms with parent drug kinetic parameters, toxicity, and efficacy of this drug in these patients. OUTLINE: This is a multicenter study. Patients receive ixabepilone IV over 1 hour once weekly on weeks 1-3. Treatment repeats every 4 weeks for a total of 3 courses in the absence of disease progression or unacceptable toxicity. PROJECTED ACCRUAL: A total of 12-37 patients will be accrued for this study within 12 months.


Criteria:

DISEASE CHARACTERISTICS: - Histologically or cytologically confirmed stage III or IV ovarian epithelial cancer or primary peritoneal carcinoma - Recurrent or refractory disease - Previously treated with 1, and only 1, prior chemotherapy regimen containing carboplatin, cisplatin, or another organoplatinum compound and paclitaxel or docetaxel - Initial treatment may include high-dose, consolidation, or extended therapy administered after surgical or non-surgical assessment - Bidimensionally measurable disease by physical exam, CT scan, or MRI - Ascites and pleural effusions are not measurable disease - No prior irradiation to indicator lesions PATIENT CHARACTERISTICS: Age - 18 to 75 Performance status - GOG 0-2 Life expectancy - Not specified Hematopoietic - Absolute neutrophil count at least 1,500/mm^3 - Platelet count at least 100,000/mm^3 - No prior bleeding disorder or unexplained bleeding Hepatic - Bilirubin no greater than 1.5 times upper limit of normal (ULN) - SGOT/SGPT no greater than 2.5 times ULN - Alkaline phosphatase no greater than 2.5 times ULN Renal - Creatinine no greater than 1.5 times ULN Other - No active infection requiring antibiotics - No grade 2 or greater neuropathy (sensory and motor) - No other malignancy within the past 5 years except nonmelanoma skin cancer - No prior recurrent grade 2 or greater hypersensitivity reactions to Cremophor EL, docetaxel, or paclitaxel - No other medical condition that would preclude study participation - Not pregnant or nursing - Negative pregnancy test - Fertile patients must use effective contraception PRIOR CONCURRENT THERAPY: Biologic therapy - At least 3 weeks since prior biologic or immunologic therapy for ovarian epithelial or primary peritoneal carcinoma Chemotherapy - See Disease Characteristics - At least 3 weeks since prior chemotherapy and recovered - No prior ixabepilone - No prior cytotoxic chemotherapy (including retreatment with initial chemotherapy regimens) for recurrent or persistent ovarian epithelial or primary peritoneal carcinoma Endocrine therapy - At least 1 week since prior hormonal therapy for ovarian epithelial or primary peritoneal carcinoma - Concurrent hormonal replacement therapy allowed Radiotherapy - See Disease Characteristics - At least 3 weeks since prior radiotherapy and recovered - No prior radiotherapy to a site of measurable disease used on study - No prior radiotherapy to more than 25% of bone marrow Surgery - See Disease Characteristics - Recovered from prior surgery Other - At least 3 weeks since other prior therapies for ovarian epithelial or primary peritoneal carcinoma - No prior cancer treatment for other invasive malignancies that would preclude study participation - No concurrent heparin or other anticoagulants - No concurrent Hypericum perforatum (St. John's wort) or any product containing this compound


NCT ID:

NCT00030706


Primary Contact:

Study Chair
Gary L. Goldberg, MD
Albert Einstein College of Medicine of Yeshiva University


Backup Contact:

N/A


Location Contact:

Bronx, New York 10461
United States



There is no listed contact information for this specific location.

Site Status: N/A


Data Source: ClinicalTrials.gov

Date Processed: December 11, 2017

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