Status:
COMPLETED
Ixabepilone and Ketoconazole in Treating Patients With Advanced Solid Tumors
Lead Sponsor:
Montefiore Medical Center
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Unspecified Adult Solid Tumor, Protocol Specific
Eligibility:
All Genders
18-120 years
Phase:
PHASE1
Brief 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 ...
Detailed Description
OBJECTIVES: Primary * Determine the effect of ketoconazole on the pharmacokinetics of ixabepilone in patients with advanced solid tumors. Secondary * Determine the safety of ixabepilone when admin...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
March 1 2003
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 5 2005
Estimated Enrollment :
29 Patients enrolled
Trial Details
Trial ID
NCT00096317
Start Date
March 1 2003
End Date
December 5 2005
Last Update
October 31 2018
Active Locations (1)
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1
Albert Einstein Cancer Center at Albert Einstein College of Medicine
The Bronx, New York, United States, 10461