Ixabepilone in Treating Patients With Relapsed and/or Refractory Stage III or Stage IV Ovarian Epithelial or Primary Peritoneal Cancer
Study Details
Study Description
Brief 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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
| Phase 2 |
Detailed Description
OBJECTIVES:
Primary
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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.
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Determine the nature and degree of toxicity of this drug in these patients.
Secondary
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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).
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Correlate CYP3A4 (3A41B), 3A5 (3A51), 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.
Study Design
Outcome Measures
Primary Outcome Measures
- Incidence of clinical remission [up to 12-months post-treatment]
number of participants experience clinical remission will be determined
Eligibility Criteria
Criteria
DISEASE CHARACTERISTICS:
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Histologically or cytologically confirmed stage III or IV ovarian epithelial cancer or primary peritoneal carcinoma
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Recurrent or refractory disease
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Previously treated with 1, and only 1, prior chemotherapy regimen containing carboplatin, cisplatin, or another organoplatinum compound and paclitaxel or docetaxel
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Initial treatment may include high-dose, consolidation, or extended therapy administered after surgical or non-surgical assessment
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Bidimensionally measurable disease by physical exam, CT scan, or MRI
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Ascites and pleural effusions are not measurable disease
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No prior irradiation to indicator lesions
PATIENT CHARACTERISTICS:
Age
- 18 to 75
Performance status
- GOG 0-2
Life expectancy
- Not specified
Hematopoietic
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Absolute neutrophil count at least 1,500/mm^3
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Platelet count at least 100,000/mm^3
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No prior bleeding disorder or unexplained bleeding
Hepatic
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Bilirubin no greater than 1.5 times upper limit of normal (ULN)
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SGOT/SGPT no greater than 2.5 times ULN
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Alkaline phosphatase no greater than 2.5 times ULN
Renal
- Creatinine no greater than 1.5 times ULN
Other
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No active infection requiring antibiotics
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No grade 2 or greater neuropathy (sensory and motor)
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No other malignancy within the past 5 years except nonmelanoma skin cancer
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No prior recurrent grade 2 or greater hypersensitivity reactions to Cremophor EL, docetaxel, or paclitaxel
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No other medical condition that would preclude study participation
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Not pregnant or nursing
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Negative pregnancy test
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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
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See Disease Characteristics
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At least 3 weeks since prior chemotherapy and recovered
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No prior ixabepilone
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No prior cytotoxic chemotherapy (including retreatment with initial chemotherapy regimens) for recurrent or persistent ovarian epithelial or primary peritoneal carcinoma
Endocrine therapy
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At least 1 week since prior hormonal therapy for ovarian epithelial or primary peritoneal carcinoma
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Concurrent hormonal replacement therapy allowed
Radiotherapy
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See Disease Characteristics
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At least 3 weeks since prior radiotherapy and recovered
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No prior radiotherapy to a site of measurable disease used on study
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No prior radiotherapy to more than 25% of bone marrow
Surgery
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See Disease Characteristics
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Recovered from prior surgery
Other
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At least 3 weeks since other prior therapies for ovarian epithelial or primary peritoneal carcinoma
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No prior cancer treatment for other invasive malignancies that would preclude study participation
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No concurrent heparin or other anticoagulants
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No concurrent Hypericum perforatum (St. John's wort) or any product containing this compound
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Albert Einstein Cancer Center at Albert Einstein College of Medicine | Bronx | New York | United States | 10461 |
Sponsors and Collaborators
- Montefiore Medical Center
- National Cancer Institute (NCI)
Investigators
- Principal Investigator: Gary L. Goldberg, MD, Albert Einstein College of Medicine
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- CDR0000069190
- P30CA013330
- AECM-3632
- MCC-12602
- NCI-3632