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

Phase 1
18 Years
Open (Enrolling)
Unspecified Adult Solid Tumor, Protocol Specific

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Trial Information

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

OBJECTIVES: I. Determine the maximum tolerated dose and recommended phase II dose, dose
limiting toxicities, and safety of BMS-188787 in patients with nonhematologic malignancies.
II. Determine the plasma pharmacokinetics of BMS-188797 in these patients. III. Describe any
antitumor activity of this treatment in these patients.

OUTLINE: This is a dose escalation study. Patients receive BMS-188797 IV over 1 hour.
Treatment continues every 21 days 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 6 patients experience dose limiting toxicities. Patients are followed every 4 weeks until
toxicities resolve, and then at the investigator's discretion.

PROJECTED ACCRUAL: Approximately 20-40 patients will be accrued for this study over 12-18

Inclusion Criteria

DISEASE CHARACTERISTICS: Histologically or cytologically confirmed nonhematologic
malignancy unresponsive to existing therapy or for which no curative therapy exists
Patients with prostate cancer must have withdrawn from antiandrogen therapy (flutamide,
bicalutamide) for at least 4 weeks and must have progressive disease Measurable or
evaluable disease No active brain metastases (e.g., cerebral edema, progression from prior
imaging study, requirement for steroids, or clinical symptoms)

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) (unless due to hepatic metastases) Renal:
Creatinine less than 1.5 times ULN Other: No serious uncontrolled medical disorder or
active infection that would preclude study No hypersensitivity to agents containing
polyoxyethylated castor oil (Cremophor EL) except in patients who received prior taxane
therapy with premedication and did not experience greater than grade 1 hypersensitivity
reaction 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
Chemotherapy: At least 4 weeks since prior chemotherapy (6 weeks since prior nitrosoureas,
mitomycin, or carboplatin) Prior taxanes allowed No other concurrent chemotherapy
Endocrine therapy: See Disease Characteristics At least 2 weeks since prior hormonal
therapy No concurrent steroids No concurrent hormonal therapy (except leuprolide acetate
for prostate cancer) Radiotherapy: At least 4 weeks since prior radiotherapy to 30% or
more of bone marrow No concurrent radiotherapy Surgery: Not specified Other: No other
concurrent investigational anticancer therapy

Type of Study:


Study Design:

Primary Purpose: Treatment

Principal Investigator

William S. Dalton, MD, PhD

Investigator Role:

Study Chair

Investigator Affiliation:

H. Lee Moffitt Cancer Center and Research Institute


United States: Federal Government

Study ID:




Start Date:

Completion Date:

Related Keywords:

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