BMS-188797 in Treating Patients With Advanced Solid Tumors That Have Not Responded to Previous Treatment

The recruitment status of this study is unknown because the information has not been verified recently.
Verified August 2000 by National Cancer Institute (NCI).
Recruitment status was  Active, not recruiting
Sponsor:
Collaborator:
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00005611
First received: May 2, 2000
Last updated: July 23, 2008
Last verified: August 2000
  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-188797 in treating patients who have advanced solid tumors that have not responded to previous treatment.


Condition Intervention Phase
Unspecified Adult Solid Tumor, Protocol Specific
Drug: BMS-188797
Phase 1

Study Type: Interventional
Study Design: Primary Purpose: Treatment
Official Title: Phase I Study of BMS-188797 in Patients With Advanced Malignancies

Resource links provided by NLM:


Further study details as provided by National Cancer Institute (NCI):

Detailed Description:

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 months.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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unresponsive to existing therapy or for which no curative therapy exists Patients with prostate cancer must have withdrawn from antiandrogen therapy (flutamide, bicalutamide) for at least 4 weeks and must have progressive disease Measurable or evaluable disease No active brain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

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00005611

Sponsors and Collaborators
H. Lee Moffitt Cancer Center and Research Institute
Investigators
Study Chair: William S. Dalton, MD, PhD H. Lee Moffitt Cancer Center and Research Institute
  More Information

Additional Information:
No publications provided

ClinicalTrials.gov Identifier: NCT00005611     History of Changes
Other Study ID Numbers: CDR0000067740, MCC-11836, BMS-CA159-001, MCC-IRB-5140, NCI-G00-1744
Study First Received: May 2, 2000
Last Updated: July 23, 2008
Health Authority: United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
unspecified adult solid tumor, protocol specific

ClinicalTrials.gov processed this record on April 15, 2014