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BMS-188797 and Carboplatin in Treating Patients With Advanced Nonhematologic Cancer

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. Identifier: NCT00006086
Recruitment Status : Completed
First Posted : May 22, 2003
Last Update Posted : September 9, 2010
National Cancer Institute (NCI)
Information provided by:
National Cancer Institute (NCI)

Brief Summary:

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells.

PURPOSE: Phase I trial to study the effectiveness of BMS-188797 and carboplatin in treating patients who have advanced nonhematologic cancer.

Condition or disease Intervention/treatment Phase
Unspecified Adult Solid Tumor, Protocol Specific Drug: BMS-188797 Drug: carboplatin Phase 1

Detailed Description:


  • Determine the recommended phase II dose based on the maximum tolerated dose of BMS-188797 when administered with carboplatin in patients with advanced nonhematologic malignancies.
  • Assess the dose limiting toxicities and safety of this treatment regimen in these patients.
  • Determine the plasma pharmacokinetics of this treatment regimen in these patients.
  • Determine any antitumor activity of this treatment regimen in these patients.

OUTLINE: This is a dose escalation study of BMS-188797.

Patients receive BMS-188797 IV over 1 hour followed by carboplatin IV over 30 minutes on day 1. Treatment repeats every 21 days for a minimum of 2 courses in the absence of disease progression or unacceptable toxicity.

Cohorts of 3-6 patients receive escalating doses of BMS-188797 until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 6 patients experience dose limiting toxicities.

Patients are followed for 4 weeks, and then every 3 months thereafter.

PROJECTED ACCRUAL: Approximately 35 patients will be accrued for this study over 12 months.

Study Type : Interventional  (Clinical Trial)
Primary Purpose: Treatment
Official Title: Phase I Study of BMS-188797 in Combination With Carboplatin in Patients With Advanced Malignancies
Study Start Date : June 2000
Primary Completion Date : February 2003

Resource links provided by the National Library of Medicine

Drug Information available for: Carboplatin
U.S. FDA Resources

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No


  • Histologically or cytologically confirmed advanced nonhematologic malignancy that has progressed on standard therapy or for which no curative therapy exists
  • No brain metastases



  • 18 and over

Performance status:

  • ECOG 0-2

Life expectancy:

  • At least 3 months


  • Absolute neutrophil count at least 1,500/mm^3
  • Platelet count at least 100,000/mm^3


  • Bilirubin no greater than 1.5 mg/dL
  • ALT and AST no greater than 2.5 times upper limit of normal (ULN) unless due to hepatic metastases


  • Creatinine no greater than 1.5 times ULN


  • No chronic medical condition requiring treatment with corticosteroids
  • No prior severe hypersensitivity reaction to agents containing Cremophor (polyoxyethylated castor oil)
  • No serious uncontrolled medical disorder, active infection, or psychiatric disorder (e.g., dementia) that would preclude study
  • No preexisting neurotoxicity grade 1 or greater
  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception


Biologic therapy:

  • At least 4 weeks since prior immunotherapy and recovered
  • No concurrent immunotherapy


  • At least 4 weeks since prior chemotherapy (6 weeks for nitrosoureas or mitomycin) and recovered
  • No more than 2 prior chemotherapy regimens for metastatic disease
  • No prior platinum or taxane therapy
  • No other concurrent chemotherapy

Endocrine therapy:

  • At least 2 weeks since prior hormonal therapy (except megestrol for anorexia/cachexia) and recovered
  • At least 7 days since prior corticosteroids
  • No concurrent corticosteroids
  • No concurrent hormonal therapy


  • At least 4 weeks since prior radiotherapy to 30% or more of bone marrow and recovered
  • No concurrent radiotherapy


  • Not specified


  • No other concurrent investigational drug

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 identifier (NCT number): NCT00006086

United States, Florida
H. Lee Moffitt Cancer Center and Research Institute
Tampa, Florida, United States, 33612-9497
Sponsors and Collaborators
H. Lee Moffitt Cancer Center and Research Institute
National Cancer Institute (NCI)
Study Chair: Daniel M. Sullivan, MD H. Lee Moffitt Cancer Center and Research Institute

Publications of Results: Identifier: NCT00006086     History of Changes
Other Study ID Numbers: CDR0000068078
First Posted: May 22, 2003    Key Record Dates
Last Update Posted: September 9, 2010
Last Verified: September 2002

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

Additional relevant MeSH terms:
Antineoplastic Agents