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.
Studieoversigt
Status
Status
Betingelser
Betingelser
Intervention / Behandling
Intervention / Behandling
Detaljeret beskrivelse
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.
Undersøgelsestype
Undersøgelsestype
Fase
Fase
- Fase 1
Kontakter og lokationer
Studiesteder
-
-
Florida
-
Tampa, Florida, Forenede Stater, 33612-9497
- H. Lee Moffitt Cancer Center and Research Institute
-
-
Deltagelseskriterier
Berettigelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Beskrivelse
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
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
Samarbejdspartnere og efterforskere
Sponsor
Sponsor
Samarbejdspartnere
Samarbejdspartnere
Efterforskere
Efterforskere
- Studiestol: Daniel M. Sullivan, MD, H. Lee Moffitt Cancer Center and Research Institute
Publikationer og nyttige links
Datoer for undersøgelser
Studer store datoer
Studiestart
Studiestart
Primær færdiggørelse (Faktiske)
Primær færdiggørelse
Datoer for studieregistrering
Først indsendt
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først indsendt, der opfyldte QC-kriterier
Først opslået (Skøn)
Først opslået
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
Sidste opdatering sendt
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
Andre undersøgelses-id-numre
- CDR0000068078
- MCC-12176
- BMS-CA159-003
- NCI-G00-1825
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .