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

This study has been completed.
Sponsor:
Collaborator:
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00006086
First received: August 3, 2000
Last updated: September 8, 2010
Last verified: September 2002
  Purpose

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 Intervention Phase
Unspecified Adult Solid Tumor, Protocol Specific
Drug: BMS-188797
Drug: carboplatin
Phase 1

Study Type: Interventional
Study Design: Primary Purpose: Treatment
Official Title: Phase I Study of BMS-188797 in Combination With Carboplatin in Patients With Advanced Malignancies

Resource links provided by NLM:


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

Study Start Date: June 2000
Primary Completion Date: February 2003 (Final data collection date for primary outcome measure)
Detailed Description:

OBJECTIVES:

  • 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.

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

PATIENT CHARACTERISTICS:

Age:

  • 18 and over

Performance status:

  • ECOG 0-2

Life expectancy:

  • At least 3 months

Hematopoietic:

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

Hepatic:

  • 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

Renal:

  • Creatinine no greater than 1.5 times ULN

Other:

  • 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

PRIOR CONCURRENT THERAPY:

Biologic therapy:

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

Chemotherapy:

  • 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

Radiotherapy:

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

Surgery:

  • Not specified

Other:

  • No other concurrent investigational drug
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00006086

Locations
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
Investigators
Study Chair: Daniel M. Sullivan, MD H. Lee Moffitt Cancer Center and Research Institute
  More Information

Additional Information:
Publications:
ClinicalTrials.gov Identifier: NCT00006086     History of Changes
Other Study ID Numbers: CDR0000068078, MCC-12176, BMS-CA159-003, NCI-G00-1825
Study First Received: August 3, 2000
Last Updated: September 8, 2010
Health Authority: United States: Federal Government

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

Additional relevant MeSH terms:
Carboplatin
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on April 16, 2014