Ixabepilone and Ketoconazole in Treating Patients With Advanced Solid Tumors

• Status: Completed
• Trial end date: 2005-12-05
• Target enrollment: 0
• Participant gender: All

Summary

RATIONALE: Drugs used in chemotherapy, such as ixabepilone and ketoconazole, work in different ways to stop tumor cells from dividing so they stop growing or die. Giving ixabepilone with ketoconazole may kill more tumor cells.

PURPOSE: This phase I/II trial is studying the side effects and best dose of giving ixabepilone together with ketoconazole and to see how well they work in treating patients with advanced solid tumors.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

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

Criteria

DISEASE CHARACTERISTICS:

• Histologically or cytologically confirmed solid tumor

• Unresponsive to currently available therapy OR no known effective treatment exists

• Measurable or nonmeasurable disease

• Brain metastases allowed, provided the following criteria are met:

• Completed cranial radiotherapy at least 4 weeks ago

• Stable or reduced brain metastases by brain imaging*

• Clinically stable disease AND no steroid therapy within the past 2 weeks (Baseline brain imaging is not required for patients with no signs or symptoms of brain metastasis)

PATIENT CHARACTERISTICS:

Age

• 18 and over

Performance status

• Eastern Cooperative Oncology Group (ECOG) 0-1

Life expectancy

• Not specified

Hematopoietic

• Not specified

Hepatic

• Not specified

Renal

• Not specified

PRIOR CONCURRENT THERAPY:

Biologic therapy

• Not specified

Chemotherapy

• No more than 3 prior chemotherapy regimens

• No other concurrent chemotherapy (standard or investigational)

Endocrine therapy

• See Disease Characteristics

Radiotherapy

• See Disease Characteristics

• At least 3 weeks since prior radiotherapy and recovered

• No prior radiotherapy to > 25% of major bone-marrow containing areas (e.g., pelvis or lumbar spine)

Surgery

• At least 1 week since prior minor surgery and recovered

• At least 3 weeks since prior major surgery and recovered

Other

• More than 2 weeks since prior drugs that would inhibit or stimulate drug metabolism