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Phase I Study of BMS-247550 in Patients With Refractory Neoplasms

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

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Trial Information

Phase I Study of BMS-247550 in Patients With Refractory Neoplasms

OBJECTIVES: I. Determine the maximum tolerated dose, dose-limiting toxic effects, and
recommended phase II dose of BMS-247550 in patients with refractory neoplasms.

II. Evaluate the pharmacokinetics and pharmacodynamics of this drug in these patients.

III. Determine the occurrence of response in patients treated with this drug.

PROTOCOL OUTLINE: This is a dose-escalation study. Patients receive BMS-247550 IV over 1
hour on days 1-5. Treatment continues every 3 weeks in the absence of disease progression
or unacceptable toxicity.

Cohorts of 1-6 patients receive escalating doses of BMS-247550 until the maximum tolerated
dose (MTD) is determined. The MTD is defined as the dose preceding that at which at least 2
of 6 patients experience dose-limiting toxicity (DLT). Once the MTD is determined,
additional patients are accrued to receive BMS-247550 at the recommended phase II dose.

If neutropenia is identified as the DLT, a second dose escalation is performed to identify
the MTD of BMS-247550 with the addition of filgrastim (G-CSF) in cohorts as above. Patients
receive fixed-dose G-CSF 72 hours after final BMS-247550 dose, and continuing until blood
levels return to normal.


A total of 45 patients will be accrued for this study within 12-18 months.

Inclusion Criteria


--Disease Characteristics-- Histologically or cytologically confirmed neoplasm refractory
to standard therapy or for which no standard therapy exists No CNS malignancy
--Prior/Concurrent Therapy-- Biologic therapy: At least 4 months since prior myeloablative
chemotherapy followed by bone marrow or stem cell rescue Chemotherapy: See Biologic
therapy At least 4 weeks since prior chemotherapy (6 weeks for prior nitrosoureas or
mitomycin) Endocrine therapy: At least 2 weeks since prior hormonal therapy for breast
cancer At least 4 weeks since prior hormonal therapy for prostate cancer Radiotherapy: At
least 4 weeks since prior radiotherapy No prior craniospinal irradiation, total body
irradiation, or radiation to more than half of pelvis Surgery: Not specified Other: No
other concurrent investigational drugs --Patient Characteristics-- Age: 18 and over
Performance status: ECOG 0-2 Life expectancy: At least 3 months Hematopoietic: Platelet
count at least 100,000/mm3 Absolute granulocyte count at least 1,500/mm3 Hepatic:
SGOT/SGPT no greater than 2.5 times normal Bilirubin no greater than 1.5 times normal (no
greater than 3 times normal if evidence of Gilbert's disease) Renal: Creatinine no greater
than 1.5 mg/dL OR Creatinine clearance at least 50 mL/min Other: Not pregnant or nursing
Negative pregnancy test Fertile patients must use effective contraception during and for 2
months after study No other nonmalignant systemic disease or serious medical illness No
active uncontrolled infection HIV negative

Type of Study:


Study Design:

Primary Purpose: Treatment

Principal Investigator

Jame Abraham

Investigator Role:

Study Chair

Investigator Affiliation:

National Cancer Institute (NCI)


United States: Federal Government

Study ID:




Start Date:

September 2000

Completion Date:

Related Keywords:

  • Unspecified Adult Solid Tumor, Protocol Specific
  • Neutropenia
  • adult solid tumor
  • bone marrow suppression
  • cancer
  • cancer-related problem/condition
  • neutropenia
  • solid tumor
  • unspecified adult solid tumor, protocol specific
  • Neutropenia



Medicine Branch Bethesda, Maryland  20892