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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:
National Cancer Institute (NCI)
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
History of Changes
  Purpose

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.


Condition Intervention Phase
Unspecified Adult Solid Tumor, Protocol Specific
 Drug: ixabepilone
Drug: ketoconazole
 Phase 1
Phase 2

Study Type: Interventional
Study Design: Masking: Open Label
Primary Purpose: Treatment
Official Title: Effect Of Ketoconazole On The Pharmacokinetics Of BMS-247550 In Patients With Advanced Cancer

Resource links provided by NLM:

MedlinePlus related topics: Cancer
U.S. FDA Resources

Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:
  • Effect of ketoconazole on the pharmacokinetics of ixabepilone [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Safety of ixabepilone with and without ketoconazole [ Designated as safety issue: Yes ]
  • Antitumor activity [ Designated as safety issue: No ]

Study Start Date: March 2003
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 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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00096317

Locations
United States, New York
Albert Einstein Cancer Center at Albert Einstein College of Medicine
Bronx, New York, United States, 10461
Sponsors and Collaborators
Albert Einstein College of Medicine of Yeshiva University
National Cancer Institute (NCI)
Investigators
Study Chair: Sridhar Mani, MD Albert Einstein College of Medicine of Yeshiva University
  More Information

Additional Information:
Clinical trial summary from the National Cancer Institute's PDQ® database  This link exits the ClinicalTrials.gov site

Publications:

ClinicalTrials.gov Identifier: NCT00096317     History of Changes
Other Study ID Numbers: CDR0000393439, AECM-03099, AECM-CA163402, AECM-NMC-03-10-277C
Study First Received: November 9, 2004
Last Updated: November 12, 2008
Health Authority: United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
unspecified adult solid tumor, protocol specific

Additional relevant MeSH terms:
Neoplasms
Ketoconazole
14-alpha Demethylase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
 Pharmacologic Actions
Antifungal Agents
Anti-Infective Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on May 16, 2013