Clinical Trial: BMS-247550 in Treating Patients With Advanced Cancers

This study is currently recruiting patients.

Sponsors and Collaborators: University of Texas
National Cancer Institute (NCI)
Information provided by: National Cancer Institute (NCI)

Purpose

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die.

PURPOSE: Phase I trial to study the effectiveness of BMS-247550 in treating patients who have malignant solid tumors or lymphoma.

Condition Treatment or Intervention Phase
adult solid tumor
Leukemia
Lymphoma
small intestine cancer
 Drug: ixabepilone
 Procedure: chemotherapy
Phase I

MedlinePlus related topics:  Cancer;   Cancer Alternative Therapy;   Digestive Diseases;   Leukemia, Adult Acute;   Leukemia, Adult Chronic;   Leukemia, Childhood;   Lymphoma

Study Type: Interventional
Study Design: Treatment

Official Title: Phase I Study of BMS-247550 in Patients With Advanced Malignancies

Further Study Details: 

OBJECTIVES:

  • Determine the maximum tolerated dose and recommended phase II dose of BMS-247550 in patients with advanced malignancies.
  • Determine the qualitative and quantitative toxic effects of this regimen in these patients.
  • Determine the pharmacokinetics and pharmacodynamics of this regimen in these patients.
  • Determine the antitumor effects of this regimen in these patients.

OUTLINE: This is a dose-escalation study. Patients are stratified according to prior therapy (heavily pretreated vs minimally pretreated).

Patients receive BMS-247550 IV over 1 hour once weekly on weeks 1-4. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.

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 6 patients experience dose-limiting toxicity. Once the MTD is determined, additional patients are treated at that dose level. Patients treated at the MTD receive treatment once weekly on weeks 1-3 of each 4-week course.

Patients are followed within 1 month.

PROJECTED ACCRUAL: Approximately 54 patients will be accrued for this study within 1 year.

Eligibility

Ages Eligible for Study:  18 Years and above,  Genders Eligible for Study:  Both

Criteria

DISEASE CHARACTERISTICS:

PATIENT CHARACTERISTICS: Age:

  • 18 and over

Performance status:

  • ECOG 0-2

Life expectancy:

  • At least 12 weeks

Hematopoietic:

  • Neutrophil count at least 1,500/mm^3
  • Hemoglobin at least 8.5 g/dL
  • Platelet count at least 100,000/mm^3

Hepatic:

  • Bilirubin no greater than 1.5 mg/dL

Renal:

  • Creatinine no greater than 1.5 mg/dL

Cardiovascular:

  • No atrial or ventricular arrhythmias requiring medication
  • No ischemic event within the past 6 months

Other:

  • No pre-existing peripheral neuropathy greater than grade 1
  • No other serious medical illness or active infection that would preclude study participation
  • No dementia, psychiatric illness, or other alteration in mental status that would preclude study compliance
  • No other active malignancy except curatively treated basal cell skin cancer or carcinoma in situ of the cervix
  • No history of allergy or hypersensitivity reaction to paclitaxel or other Cremophor EL-containing compound
  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception during and for 2 months after study completion

PRIOR CONCURRENT THERAPY: Biologic therapy:

  • No concurrent immunotherapy

Chemotherapy:

  • At least 4 weeks since prior chemotherapy (6 weeks for mitomycin or nitrosoureas) and recovered
  • No other concurrent chemotherapy

Endocrine therapy:

Radiotherapy:

Surgery:

  • At least 4 weeks since prior surgery and recovered

Other:


Location and Contact Information


Texas
      Cancer Therapy and Research Center, San Antonio,  Texas,  78229,  United States; Recruiting
Eric Keith Rowinsky, MD  210-616-5945    erowinsk@idd.org 

      University of Texas Health Science Center at San Antonio, San Antonio,  Texas,  78284-7811,  United States; Recruiting
Eric Keith Rowinsky, MD  210-567-4777    erowinsk@idd.org 

      Veterans Affairs Medical Center - San Antonio (Murphy), San Antonio,  Texas,  78229,  United States; Recruiting
Geoffrey R. Weiss, MD  210-617-5186 

Study chairs or principal investigators

Eric Keith Rowinsky, MD,  Study Chair,  Cancer Therapy and Research Center   

More Information

Clinical trial summary from the National Cancer Institute's PDQ® database

Study ID Numbers:  CDR0000068141; UTHSC-IDD-99-32; SACI-IDD-99-32; NCI-150; NCT00006221
Record last reviewed:  June 2004
Last Updated:  December 6, 2004
Record first received:  September 11, 2000
ClinicalTrials.gov Identifier:  NCT00006221
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-04-08


Source: ClinicalTrials.gov
Cache Date: April 9, 2005

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