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CompletedNCT00006086Updated Sep 9, 2010

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

A Phase 1 interventional study of BMS-188797 and carboplatin in Unspecified Adult Solid Tumor, Protocol Specific, sponsored by H. Lee Moffitt Cancer Center and Research Institute. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2010-09-09.

Sponsored by H. Lee Moffitt Cancer Center and Research Institute · Phase 1, Interventional, and Treatment

Phase
Phase 1
Study type
Interventional
Ages
18 Years and older
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Unspecified Adult Solid Tumor, Protocol Specific

Keywords

  • unspecified adult solid tumor, protocol specific
03

In context

Lead sponsor

H. Lee Moffitt Cancer Center and Research Institute is the lead sponsor of 533 studies on the registry; 74 are open to participants now.

Of its 99 completed or terminated interventional studies of FDA-regulated products, 57 (58%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Eligibility 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
05

Study design

Phase
Phase 1
Primary purpose
Treatment

Interventions

  • DrugBMS-188797
  • Drugcarboplatin
06

Study locations

1 site
  • H. Lee Moffitt Cancer Center and Research Institute
    Tampa, Florida 33612-9497, United States
07

References and documents

Publications

  • Fishman MN, Garrett CR, Simon GR, Chiappori AA, Lush RM, Dinwoodie WR, Mahany JJ, Dellaportas AM, Cantor A, Gollerki A, Cohen MB, Sullivan DM. Phase I study of the taxane BMS-188797 in combination with carboplatin administered every 3 weeks in patients with solid malignancies. Clin Cancer Res. 2006 Jan 15;12(2):523-8. doi: 10.1158/1078-0432.CCR-05-0928. PubMed 16428495 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 9, 2010, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00006086
Lead sponsor
H. Lee Moffitt Cancer Center and Research Institute
Collaborators
National Cancer Institute (NCI)
First posted
May 22, 2003
Start date
Jun 2000
Primary completion
Feb 2003
Last update
Sep 9, 2010

Study contacts

Daniel M. Sullivan, MD
study chair · H. Lee Moffitt Cancer Center and Research Institute
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Sep 2002. You cannot join it, but the record below documents what was studied.

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