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BMS-214662 in Treating Patients With Solid Tumors
This study has been completed.
First Received: July 5, 2000   Last Updated: July 23, 2008   History of Changes
Sponsors and Collaborators: M.D. Anderson Cancer Center
National Cancer Institute (NCI)
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00005973
  Purpose

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die.

PURPOSE: Phase I trial to study the effectiveness of BMS-214662 in treating patients who have solid tumors.


Condition Intervention Phase
Unspecified Adult Solid Tumor, Protocol Specific
Unspecified Childhood Solid Tumor, Protocol Specific
Drug: BMS-214662
Phase I

MedlinePlus related topics: Cancer
Drug Information available for: BMS 214662
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment
Official Title: Phase I Study of Farnesyl Transferase Inhibitor BMS-214662 (NSC7100860) in Solid Tumors

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

Study Start Date: December 2000
Detailed Description:

OBJECTIVES:

  • Determine the maximum tolerated dose of BMS-214662 in patients with solid tumors.
  • Evaluate intermediate biological endpoints as surrogates for the effectiveness of this drug in these patients.
  • Determine the nature of dose limiting toxicity of this drug in this patient population.
  • Determine the recommended phase II regimen of this drug in these patients.
  • Establish a pharmacologic and pharmacokinetic profile of this drug in these patients.

OUTLINE: This is a dose escalation study.

Patients receive BMS-214662 IV over 1 hour on days 1, 8, 15, and 22. Treatment repeats every 6 weeks in the absence of disease progression or unacceptable toxicity.

Cohorts of 3-6 patients receive escalating doses of BMS-214662 until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose at which 2 of 6 patients experience dose limiting toxicities.

Patients are followed every 3 months for at least 24 months.

PROJECTED ACCRUAL: A total of 36 patients will be accrued for this study.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

DISEASE CHARACTERISTICS:

  • Diagnosis of malignant solid tumor for which a standard curative therapy does not exist

PATIENT CHARACTERISTICS:

Age:

  • Any age

Performance status:

  • Karnofsky 70-100%

Life expectancy:

  • At least 6 months

Hematopoietic:

  • WBC at least 3,000/mm^3
  • Absolute neutrophil count at least 1,500/mm^3
  • Platelet count at least 100,000/mm^3
  • Hemoglobin at least 10.0 g/dL

Hepatic:

  • Bilirubin no greater than 2.0 mg/dL
  • AST no greater than 2 times upper limit of normal
  • Albumin at least 3.0 g/dL

Renal:

  • Creatinine no greater than 1.5 mg/dL

Cardiovascular:

  • No uncontrolled heart disease
  • No history of clinically significant cardiac arrhythmia that could be exacerbated by QT interval prolongation
  • Corrected QT interval no greater than 450 milliseconds

Gastrointestinal:

  • Must not require total parenteral nutrition
  • No manifestations of malabsorption syndrome due to prior surgery, gastrointestinal disease, or unknown reasons

Other:

  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception
  • No signs or symptoms of acute infection requiring systemic therapy
  • No grade 3 or 4 neurotoxicity from prior anticancer treatment or neuropathy from any cause
  • No confusion, disorientation, or psychiatric illness that may preclude study

PRIOR CONCURRENT THERAPY:

Biologic therapy:

  • Not specified

Chemotherapy:

  • No more than 3 prior chemotherapy regimens
  • At least 4 weeks since prior chemotherapy (6 weeks since prior nitrosoureas or mitomycin) and recovered
  • No other concurrent antineoplastic agents

Endocrine therapy:

  • No concurrent hormonal anticancer therapy

Radiotherapy:

  • At least 4 weeks since prior radiotherapy
  • No concurrent radiotherapy

Surgery:

  • Not specified

Other:

  • Prior drugs known to prolong the QT interval allowed if they can be safely discontinued for a time period equal to 4 elimination half-lives prior to administering study drug
  • No drugs known to prolong the QT interval during and for 24 hours after study drug
  • No concurrent therapy with known CYP3A4 substrates
  • No other concurrent investigational agents
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00005973

Locations
United States, Texas
University of Texas - MD Anderson Cancer Center
Houston, Texas, United States, 77030-4009
Sponsors and Collaborators
M.D. Anderson Cancer Center
Investigators
Study Chair: Vassiliki A. Papadimitrakopoulou, MD M.D. Anderson Cancer Center
  More Information

Additional Information:
No publications provided

Study ID Numbers: CDR0000067960, MDA-ID-99304, NCI-671
Study First Received: July 5, 2000
Last Updated: July 23, 2008
ClinicalTrials.gov Identifier: NCT00005973     History of Changes
Health Authority: United States: Federal Government

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

Additional relevant MeSH terms:
Neoplasms

ClinicalTrials.gov processed this record on May 07, 2009