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Phase I Study of BMS-247550 Given Every Three Weeks 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-247550 Given Every Three Weeks in Patients With Advanced Malignancies

OBJECTIVES: I. Determine the maximum tolerated dose, dose limiting toxicities, safety, and a
recommended phase II dose of BMS-247550 administered as a 1 hour infusion every 3 weeks in
patients with advanced solid tumors. II. Evaluate the plasma pharmacokinetics of this drug
in this patient population. III. Determine any preliminary evidence of antitumor activity of
this drug in these patients.

OUTLINE: This is a dose escalation study. Patients receive BMS-247550 IV over 1 hour every 3
weeks. Treatment continues for a minimum of 2 courses in the absence of unacceptable
toxicity or disease progression. Cohorts of 3-6 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 2 of 3 or 2 of 6 patients experience dose limiting toxicities.
Patients are followed every 3 months until death.

PROJECTED ACCRUAL: Approximately 20-40 patients will be accrued for this study within 8-12

Inclusion Criteria

DISEASE CHARACTERISTICS: Histologically or cytologically confirmed advanced solid tumor
that has failed standard therapy or for which no standard therapy exists No hematological
malignancies allowed Measurable or evaluable disease Must have clinical or radiological
evidence of disease No active brain metastases including evidence of cerebral edema by CT
or MRI, or progression from prior imaging study, any requirement for steroids, or clinical
symptoms of/from 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 Hemoglobin at least 9.0 g/dL Hepatic: Bilirubin no greater than 1.5
mg/dL AST/ALT no greater than 2.5 times upper limit of normal (ULN) Renal: Creatinine less
than 1.5 times ULN Other: Not pregnant or nursing Negative pregnancy test Fertile patients
must use effective contraception No preexisting peripheral neuropathy greater than grade 1
due to any cause No documented hypersensitivity reaction grade 2 or greater to prior
paclitaxel or other therapy containing Cremophor EL No serious uncontrolled medical
disorder or active infection that would preclude protocol therapy No dementia or altered
mental status that would preclude compliance HIV negative

PRIOR CONCURRENT THERAPY: Biologic therapy: At least 4 weeks since prior immunotherapy No
concurrent biologic therapy Chemotherapy: At least 4 weeks since prior chemotherapy (6
weeks for nitrosoureas, mitomycin, and doxorubicin HCl liposome) Prior taxanes allowed No
more than 2 prior chemotherapy regimens in metastatic setting Prior adjuvant/neoadjuvant
chemotherapy allowed No other concurrent chemotherapy Endocrine therapy: See Disease
Characteristics No concurrent hormonal therapy (except hormone replacement therapy or
medication to maintain castrate status) Radiotherapy: At least 4 weeks since prior
radiotherapy No prior radiotherapy to greater than 25% of bone marrow No concurrent
radiotherapy Surgery: No concurrent surgery Other: At least 4 weeks since other prior
investigational agents No other concurrent experimental anticancer medications No other
concurrent specific antitumor therapy

Type of Study:


Study Design:

Primary Purpose: Treatment

Principal Investigator

David R. Spriggs, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Memorial Sloan-Kettering Cancer Center


United States: Federal Government

Study ID:




Start Date:

July 1999

Completion Date:

Related Keywords:

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



Memorial Sloan-Kettering Cancer Center New York, New York  10021
Barbara Ann Karmanos Cancer Institute Detroit, Michigan  48201