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

Montefiore Medicine Academic Health System

Status and phase

Completed

Phase 2

Conditions

Peritoneal Cavity Cancer

Ovarian Cancer

Treatments

Drug: ixabepilone

Study type

Interventional

Funder types

Other

NIH

Identifiers

NCT00030706

P30CA013330 (U.S. NIH Grant/Contract)

NCI-3632

AECM-3632

MCC-12602

CDR0000069190

Details and patient eligibility

About

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.

Sex

Female

Ages

18 to 75 years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion 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