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Phase I Study of BMS-184476 in Patients With Advanced Malignancies

Phase 1
18 Years
Not Enrolling
Unspecified Adult Solid Tumor, Protocol Specific

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Trial Information

Phase I Study of BMS-184476 in Patients With Advanced Malignancies

OBJECTIVES: I. Determine the maximum tolerated dose, dose limiting toxicity, recommended
phase II dose, and safety of BMS-184476 in patients with advanced solid tumors. II.
Determine the pharmacokinetic profile of BMS-184476 and its metabolites in these patients.
III. Determine preliminary evidence of antitumor activity of BMS-184476 in these patients.

OUTLINE: This is an open label, dose escalation study. Patients receive BMS-184476 IV over 1
hour. Treatment is repeated every 21 days in the absence of disease progression or
unacceptable toxicity. In the second part of the study, patients receive BMS-184476 IV over
1 hour weekly. Cohorts of 3-6 patients are treated at escalating doses of BMS-184476. The
maximum tolerated dose is defined as the dose at which fewer than 2 of 6 patients experience
dose limiting toxicity. Patients are followed every 4 weeks until toxicity is resolved.

PROJECTED ACCRUAL: A total of 20-40 patients will be accrued for this study within 12-18

Inclusion Criteria

DISEASE CHARACTERISTICS: Histologically or cytologically confirmed advanced solid tumors
refractory to conventional anticancer therapy, or for which no effective therapy exists
Measurable or evaluable disease No active 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 2,000/mm3 Platelet count
at least 100,000/mm3 Hepatic: Bilirubin no greater than 1.5 mg/dL ALT and AST no greater
than 2.5 times upper limit of normal (ULN) Renal: Creatinine less than 1.5 times ULN
Cardiovascular: No uncontrolled or significant cardiovascular disease No myocardial
infarction within past 6 months No congestive heart failure (with or without therapy) No
history of atrial or ventricular arrhythmias No history of second or third degree heart
block Other: Not pregnant or nursing Negative pregnancy test Fertile patients must use
effective contraception No serious uncontrolled medical disorder or active infection No
known hypersensitivity to drugs containing Cremophor EL No concurrent neurologic toxicity
No dementia or altered mental status

PRIOR CONCURRENT THERAPY: Biologic therapy: At least 4 weeks since prior immunotherapy
Chemotherapy: At least 4 weeks since prior chemotherapy (6 weeks since nitrosoureas,
mitomycin, or carboplatin) Prior taxane therapy allowed No other concurrent chemotherapy
Endocrine therapy: At least 1 week since prior steroid therapy No concurrent hormonal
therapy Radiotherapy: At least 4 weeks since prior wide field radiotherapy (involving at
least 30% of the bone marrow) No concurrent radiotherapy Surgery: Not specified Other: No
other concurrent experimental anticancer medications

Type of Study:


Study Design:

Primary Purpose: Treatment

Principal Investigator

Manuel Hidalgo, MD, PhD

Investigator Role:

Study Chair

Investigator Affiliation:

Sidney Kimmel Comprehensive Cancer Center


United States: Federal Government

Study ID:




Start Date:

November 1997

Completion Date:

Related Keywords:

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



Brooke Army Medical Center Fort Sam Houston, Texas  78234-6200
San Antonio Cancer Institute San Antonio, Texas  78229-3264