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Ixabepilone and Ketoconazole in Treating Patients With Advanced Solid Tumors

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00096317
Recruitment Status : Completed
First Posted : November 9, 2004
Last Update Posted : October 31, 2018
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Montefiore Medical Center

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 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 or disease Intervention/treatment Phase
Unspecified Adult Solid Tumor, Protocol Specific Drug: ixabepilone Drug: ketoconazole Phase 1

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 29 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: The Effect of Ketoconazole on the Pharmacokinetics and Pharmacodynamics of Ixabepilone In Patients With Advanced Cancer
Actual Study Start Date : March 2003
Actual Primary Completion Date : December 5, 2005
Actual Study Completion Date : December 5, 2005

Resource links provided by the National Library of Medicine





Primary Outcome Measures :
  1. Effect of ketoconazole on the pharmacokinetics of ixabepilone

Secondary Outcome Measures :
  1. Safety of ixabepilone with and without ketoconazole
  2. Antitumor activity


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 120 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
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 (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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00096317


Locations
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United States, New York
Albert Einstein Cancer Center at Albert Einstein College of Medicine
Bronx, New York, United States, 10461
Sponsors and Collaborators
Montefiore Medical Center
National Cancer Institute (NCI)
Investigators
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Study Chair: Sridhar Mani, MD Albert Einstein College of Medicine
Publications of Results:
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Responsible Party: Montefiore Medical Center
ClinicalTrials.gov Identifier: NCT00096317    
Other Study ID Numbers: CDR0000393439
P30CA013330 ( U.S. NIH Grant/Contract )
AECM-03099
AECM-CA163402
AECM-NMC-03-10-277C
First Posted: November 9, 2004    Key Record Dates
Last Update Posted: October 31, 2018
Last Verified: October 2018

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: Yes
Keywords provided by Montefiore Medical Center:
unspecified adult solid tumor, protocol specific
Additional relevant MeSH terms:
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Ketoconazole
Antifungal Agents
Anti-Infective Agents
14-alpha Demethylase Inhibitors
Cytochrome P-450 Enzyme Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Steroid Synthesis Inhibitors
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Cytochrome P-450 CYP3A Inhibitors