Effect Of Ketoconazole On The Pharmacokinetics Of BMS-247550 In Patients With Advanced Cancer
18 Years
N/A
Both
Unspecified Adult Solid Tumor, Protocol Specific
Trial Information
Effect Of Ketoconazole On The Pharmacokinetics Of BMS-247550 In Patients With Advanced Cancer
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 administered alone and in combination with
ketoconazole in these patients.
- Determine, preliminarily, the antitumor activity of this regimen in these patients.
OUTLINE: This is an open-label, dose-escalation study of ixabepilone.
During course 1, patients receive oral ketoconazole on days 0-5 and ixabepilone IV over 3
hours on day 1. During course 2 and subsequent courses, patients receive only ixabepilone IV
over 3 hours on day 1. Courses repeat every 21 days in the absence of disease progression or
unacceptable toxicity.
Cohorts of at least 3 patients receive escalating doses of ixabepilone during course 1 until
the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding
that at which 2 of 3 patients experience dose-limiting toxicity. At least 12 patients are
treated at the MTD.
PROJECTED ACCRUAL: A total of 3-35 patients will be accrued for this study.
Inclusion 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 NOTE:
*Baseline brain imaging is not required for patients with no signs or symptoms
of brain metastasis
PATIENT CHARACTERISTICS:
Age
- 18 and over
Performance status
- 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
Type of Study:
Interventional
Study Design:
Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Effect of ketoconazole on the pharmacokinetics of ixabepilone
Safety Issue:
No
Principal Investigator
Sridhar Mani, MD
Investigator Role:
Study Chair
Investigator Affiliation:
Albert Einstein College of Medicine of Yeshiva University
Authority:
United States: Federal Government
Study ID:
CDR0000393439
NCT ID:
NCT00096317
Start Date:
March 2003
Completion Date:
Related Keywords:
- Unspecified Adult Solid Tumor, Protocol Specific
- unspecified adult solid tumor, protocol specific
- Neoplasms
Name | Location |
|---|---|
| Albert Einstein Cancer Center at Albert Einstein College of Medicine | Bronx, New York 10461 |
