Ixabepilone and Ketoconazole in Treating Patients With Advanced Solid Tumors - Full Text View

Sponsor:	Albert Einstein College of Medicine of Yeshiva University
Collaborator:	National Cancer Institute (NCI)
Information provided by:	National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:	NCT00096317

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 I Phase II

Study Type:	Interventional
Study Design:	Treatment, Open Label
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

Drug Information available for: Ketoconazole Fungarest Ixabepilone

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:

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.

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

Keywords provided by National Cancer Institute (NCI):

unspecified adult solid tumor, protocol specific

Additional relevant MeSH terms:

Anti-Infective Agents
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Therapeutic Uses
Antifungal Agents
Epothilones

Mitosis Modulators
Tubulin Modulators
Antimitotic Agents
Ketoconazole
Pharmacologic Actions

ClinicalTrials.gov processed this record on November 09, 2009