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Phase I Study of BMS-188797 in Combination With Carboplatin in Patients With Advanced Malignancies


Phase 1
18 Years
N/A
Not Enrolling
Both
Unspecified Adult Solid Tumor, Protocol Specific

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Trial Information

Phase I Study of BMS-188797 in Combination With Carboplatin in Patients With Advanced Malignancies


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.

Inclusion 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

Type of Study:

Interventional

Study Design:

Primary Purpose: Treatment

Principal Investigator

Daniel M. Sullivan, MD

Investigator Role:

Study Chair

Investigator Affiliation:

H. Lee Moffitt Cancer Center and Research Institute

Authority:

United States: Federal Government

Study ID:

CDR0000068078

NCT ID:

NCT00006086

Start Date:

June 2000

Completion Date:

Related Keywords:

  • Unspecified Adult Solid Tumor, Protocol Specific
  • unspecified adult solid tumor, protocol specific

Name

Location

H. Lee Moffitt Cancer Center and Research InstituteTampa, Florida  33612