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

• Status: Completed
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: Female

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Albert Einstein College of Medicine of Yeshiva University; Montefiore Medical Center
• Collaborator: National Cancer Institute (NCI)

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