Ixabepilone in Treating Patients With Ovarian Epithelial or Primary Peritoneal Cancer That Has Not Responded to Previous Chemotherapy

Completed · Phase 2

Conditions studied: Primary Peritoneal Cavity Cancer, Recurrent Ovarian Epithelial Cancer

In brief

Phase II trial to study the effectiveness of ixabepilone in treating patients who have recurrent or persistent ovarian epithelial or primary peritoneal cancer that has not responded to previous chemotherapy. Drugs used in chemotherapy work in different ways to stop tumor cells from dividing so they stop growing or die.

Key facts

Study ID

NCT00025155

Run by

National Cancer Institute (NCI)

People needed

51

Starts

2002-07-01

Expected to finish

2010-03-01

Last updated by the study team

2019-07-24

Who can join

Age: any. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• Histologically confirmed ovarian epithelial cancer or primary peritoneal cancer
• Recurrent or persistent disease
• Platinum AND taxane-resistant or refractory disease
• Progressed during therapy
• Refractory disease within 6 months of therapy
• Measurable disease
• At least 20 mm by conventional techniques
• At least 10 mm by spiral CT scan
• Tumor lesions located within a previously irradiated field are not considered measurable disease unless there is documented tumor progression in these lesions or biopsy confirmation ≥ 90 days following completion of radiotherapy
• Ineligible for higher priority GOG (Gynecologic Oncology Group) protocol
• No active brain metastases
• Performance status - GOG 0-2
• Absolute neutrophil count ≥ 1,500/mm\^3
• Platelet count ≥ 100,000/mm\^3
• Bilirubin ≤ 1.5 times upper limit of normal (ULN)
• SGOT (serum glutamate oxaloacetate transaminase) ≤ 2.5 times ULN
• Alkaline phosphatase ≤ 2.5 times ULN
• Creatinine ≤ 1.5 times ULN
• No sensory or motor neuropathy > grade 1
• No dementia or altered mental status
• No other serious uncontrolled medical disorder
• No active infection requiring antibiotics
• No prior hypersensitivity reaction to paclitaxel or other therapy containing Cremophor EL
• No other malignancy within the past 5 years except nonmelanoma skin cancer
• Not pregnant or nursing

Where it is running

• Gynecologic Oncology Group — Philadelphia, Pennsylvania, United States

Full record on ClinicalTrials.gov

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