Ovarian Cancer Clinical Trial
Ixabepilone in Treating Patients With Relapsed and/or Refractory Stage III or Stage IV Ovarian Epithelial or Primary Peritoneal Cancer
Summary
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.
Full Description
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.
Eligibility 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
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There is 1 Location for this study
Bronx New York, 10461, United States
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