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.

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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.

View Eligibility Criteria

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

Study is for people with:

Ovarian Cancer

Phase:

Phase 2

Study ID:

NCT00030706

Recruitment Status:

Completed

Sponsor:

Montefiore Medical Center

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There is 1 Location for this study

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Albert Einstein Cancer Center at Albert Einstein College of Medicine
Bronx New York, 10461, United States

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Study is for people with:

Ovarian Cancer

Phase:

Phase 2

Study ID:

NCT00030706

Recruitment Status:

Completed

Sponsor:


Montefiore Medical Center

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