Phase I Study of BMS-188797 in Combination With Carboplatin in Patients With Advanced Malignancies
18 Years
N/A
Both
Unspecified Adult Solid Tumor, Protocol Specific
Trial Information
Phase I Study of BMS-188797 in Combination With Carboplatin in Patients With Advanced Malignancies
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.
Inclusion Criteria
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
Type of Study:
Interventional
Study Design:
Primary Purpose: Treatment
Principal Investigator
Daniel M. Sullivan, MD
Investigator Role:
Study Chair
Investigator Affiliation:
H. Lee Moffitt Cancer Center and Research Institute
Authority:
United States: Federal Government
Study ID:
CDR0000068078
NCT ID:
NCT00006086
Start Date:
June 2000
Completion Date:
Related Keywords:
- Unspecified Adult Solid Tumor, Protocol Specific
- unspecified adult solid tumor, protocol specific
Name | Location |
|---|---|
| H. Lee Moffitt Cancer Center and Research Institute | Tampa, Florida 33612 |
