Ixabepilone and Ketoconazole in Treating Patients With Advanced Solid Tumors

The recruitment status of this study is unknown because the information has not been verified recently.
Verified January 2006 by National Cancer Institute (NCI).
Recruitment status was  Active, not recruiting
Sponsor:
Collaborator:
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00096317
First received: November 9, 2004
Last updated: November 12, 2008
Last verified: January 2006

November 9, 2004
November 12, 2008
March 2003
Not Provided
Effect of ketoconazole on the pharmacokinetics of ixabepilone [ Designated as safety issue: No ]
Not Provided
Complete list of historical versions of study NCT00096317 on ClinicalTrials.gov Archive Site
  • Safety of ixabepilone with and without ketoconazole [ Designated as safety issue: Yes ]
  • Antitumor activity [ Designated as safety issue: No ]
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Ixabepilone and Ketoconazole in Treating Patients With Advanced Solid Tumors
Effect Of Ketoconazole On The Pharmacokinetics Of BMS-247550 In Patients With Advanced Cancer

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.

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.

Interventional
Phase 1
Phase 2
Masking: Open Label
Primary Purpose: Treatment
Unspecified Adult Solid Tumor, Protocol Specific
  • Drug: ixabepilone
  • Drug: ketoconazole
Not Provided
Goel S, Cohen M, Cömezoglu SN, Perrin L, André F, Jayabalan D, Iacono L, Comprelli A, Ly VT, Zhang D, Xu C, Humphreys WG, McDaid H, Goldberg G, Horwitz SB, Mani S. The effect of ketoconazole on the pharmacokinetics and pharmacodynamics of ixabepilone: a first in class epothilone B analogue in late-phase clinical development. Clin Cancer Res. 2008 May 1;14(9):2701-9.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
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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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00096317
CDR0000393439, AECM-03099, AECM-CA163402, AECM-NMC-03-10-277C
Not Provided
Not Provided
Albert Einstein College of Medicine of Yeshiva University
National Cancer Institute (NCI)
Study Chair: Sridhar Mani, MD Albert Einstein College of Medicine of Yeshiva University
National Cancer Institute (NCI)
January 2006

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP