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Effect Of Ketoconazole On The Pharmacokinetics Of BMS-247550 In Patients With Advanced Cancer


Phase 1/Phase 2
18 Years
N/A
Open (Enrolling)
Both
Unspecified Adult Solid Tumor, Protocol Specific

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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 MedicineBronx, New York  10461