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

NCT ID: NCT00030706

Last Updated: 2018-09-28

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Study Classification: INTERVENTIONAL
• Study Start Date: 2004-11-30

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.

Detailed 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.

Conditions

Ovarian Cancer; Peritoneal Cavity Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Interventions

ixabepilone

Intervention Type: DRUG

Eligibility Criteria

Inclusion 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

National Cancer Institute (NCI)

NIH

Sponsor Role: collaborator

Montefiore Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Gary L. Goldberg, MD

Role: PRINCIPAL_INVESTIGATOR

Albert Einstein College of Medicine

Locations

Albert Einstein Cancer Center at Albert Einstein College of Medicine

The Bronx, New York, United States

Countries

United States

Other Identifiers

P30CA013330

Identifier Type: NIH

Identifier Source: secondary_id

View Link

AECM-3632

Identifier Type: -

Identifier Source: secondary_id

MCC-12602

Identifier Type: -

Identifier Source: secondary_id

NCI-3632

Identifier Type: -

Identifier Source: secondary_id

CDR0000069190

Identifier Type: -

Identifier Source: org_study_id