- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00006086
BMS-188797 and Carboplatin in Treating Patients With Advanced Nonhematologic Cancer
Phase I Study of BMS-188797 in Combination With Carboplatin in Patients With Advanced Malignancies
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells.
PURPOSE: Phase I trial to study the effectiveness of BMS-188797 and carboplatin in treating patients who have advanced nonhematologic cancer.
Study Overview
Status
Intervention / Treatment
Detailed Description
OBJECTIVES:
- Determine the recommended phase II dose based on the maximum tolerated dose of BMS-188797 when administered with carboplatin in patients with advanced nonhematologic malignancies.
- Assess the dose limiting toxicities and safety of this treatment regimen in these patients.
- Determine the plasma pharmacokinetics of this treatment regimen in these patients.
- Determine any antitumor activity of this treatment regimen in these patients.
OUTLINE: This is a dose escalation study of BMS-188797.
Patients receive BMS-188797 IV over 1 hour followed by carboplatin IV over 30 minutes on day 1. Treatment repeats every 21 days for a minimum of 2 courses 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 3 or 6 patients experience dose limiting toxicities.
Patients are followed for 4 weeks, and then every 3 months thereafter.
PROJECTED ACCRUAL: Approximately 35 patients will be accrued for this study over 12 months.
Study Type
Phase
- Phase 1
Contacts and Locations
Study Locations
-
-
Florida
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Tampa, Florida, United States, 33612-9497
- H. Lee Moffitt Cancer Center and Research Institute
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
DISEASE CHARACTERISTICS:
- Histologically or cytologically confirmed advanced nonhematologic malignancy that has progressed on standard therapy or for which no curative therapy exists
- No 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 1,500/mm^3
- Platelet count at least 100,000/mm^3
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 no greater than 1.5 times ULN
Other:
- No chronic medical condition requiring treatment with corticosteroids
- No prior severe hypersensitivity reaction to agents containing Cremophor (polyoxyethylated castor oil)
- No serious uncontrolled medical disorder, active infection, or psychiatric disorder (e.g., dementia) that would preclude study
- No preexisting neurotoxicity grade 1 or greater
- 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 and recovered
- No concurrent immunotherapy
Chemotherapy:
- At least 4 weeks since prior chemotherapy (6 weeks for nitrosoureas or mitomycin) and recovered
- No more than 2 prior chemotherapy regimens for metastatic disease
- No prior platinum or taxane therapy
- No other concurrent chemotherapy
Endocrine therapy:
- At least 2 weeks since prior hormonal therapy (except megestrol for anorexia/cachexia) and recovered
- At least 7 days since prior corticosteroids
- No concurrent corticosteroids
- No concurrent hormonal therapy
Radiotherapy:
- At least 4 weeks since prior radiotherapy to 30% or more of bone marrow and recovered
- No concurrent radiotherapy
Surgery:
- Not specified
Other:
- No other concurrent investigational drug
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
Collaborators and Investigators
Collaborators
Investigators
- Study Chair: Daniel M. Sullivan, MD, H. Lee Moffitt Cancer Center and Research Institute
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- CDR0000068078
- MCC-12176
- BMS-CA159-003
- NCI-G00-1825
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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