Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outcomes
Outline
Trial Contact Information
Registry Information

Alternate Title

Ixabepilone in Treating Patients With Relapsed and/or Refractory Stage III or Stage IV Ovarian Epithelial or Primary Peritoneal Cancer

Basic Trial Information

Phase	Type	Status	Age	Sponsor	Protocol IDs
Phase II	Treatment	Closed	18 to 75	NCI	AECM-3632 MCC-12602, NCI-3632, NCT00030706, 3632

Objectives

Primary

1. 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.
2. Determine the nature and degree of toxicity of this drug in these patients.

Secondary

1. 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).
2. 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.

Entry 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

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

Patient Characteristics:

Age

• 18 to 75

Performance status

• GOG 0-2

Life expectancy

• Not specified

Hematopoietic

• Absolute neutrophil count at least 1,500/mm³
• Platelet count at least 100,000/mm³
• 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

Expected Enrollment

A total of 12-37 patients will be accrued for this study within 12 months.

Outcomes

Incidence of clinical remission

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.

Trial Contact Information

Trial Lead Organizations

Albert Einstein Cancer Center at Albert Einstein College of Medicine

Gary Goldberg, MD, Protocol chair		Ph: 718-405-8082

Registry Information
Official Title		Phase II Study Of Epothilone B Analogue BMS-247550 In Relapse And/Or Refractory Stage III Or IV Ovarian Epithelial Cancer, Following Front-Line Treatment With Platinum Plus Taxane-Based Chemotherapy
Trial Start Date		2004-11-08
Registered in ClinicalTrials.gov		NCT00030706
Date Submitted to PDQ		2001-12-18
Information Last Verified		2006-02-23
NCI Grant/Contract Number		CA94530

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