BMS-184476 in Treating Patients With Advanced Solid Tumors
NCT ID: NCT00003705
Last Updated: 2008-07-24
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
INTERVENTIONAL
1997-11-30
Brief Summary
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PURPOSE: Phase I trial to study the effectiveness of BMS-184476 in treating patients who have advanced solid tumors.
Detailed Description
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OUTLINE: This is an open label, dose escalation study. Patients receive BMS-184476 IV over 1 hour. Treatment is repeated every 21 days in the absence of disease progression or unacceptable toxicity. In the second part of the study, patients receive BMS-184476 IV over 1 hour weekly. Cohorts of 3-6 patients are treated at escalating doses of BMS-184476. The maximum tolerated dose is defined as the dose at which fewer than 2 of 6 patients experience dose limiting toxicity. Patients are followed every 4 weeks until toxicity is resolved.
PROJECTED ACCRUAL: A total of 20-40 patients will be accrued for this study within 12-18 months.
Conditions
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Keywords
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Study Design
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TREATMENT
Interventions
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BMS-184476
Eligibility Criteria
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Inclusion Criteria
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) Renal: Creatinine less than 1.5 times ULN Cardiovascular: No uncontrolled or significant cardiovascular disease No myocardial infarction within past 6 months No congestive heart failure (with or without therapy) No history of atrial or ventricular arrhythmias No history of second or third degree heart block Other: Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception No serious uncontrolled medical disorder or active infection No known hypersensitivity to drugs containing Cremophor EL No concurrent neurologic toxicity No dementia or altered mental status
PRIOR CONCURRENT THERAPY: Biologic therapy: At least 4 weeks since prior immunotherapy Chemotherapy: At least 4 weeks since prior chemotherapy (6 weeks since nitrosoureas, mitomycin, or carboplatin) Prior taxane therapy allowed No other concurrent chemotherapy Endocrine therapy: At least 1 week since prior steroid therapy No concurrent hormonal therapy Radiotherapy: At least 4 weeks since prior wide field radiotherapy (involving at least 30% of the bone marrow) No concurrent radiotherapy Surgery: Not specified Other: No other concurrent experimental anticancer medications
18 Years
ALL
No
Sponsors
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San Antonio Cancer Institute
OTHER
Principal Investigators
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Manuel Hidalgo, MD, PhD
Role: STUDY_CHAIR
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Locations
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Brooke Army Medical Center
Fort Sam Houston, Texas, United States
San Antonio Cancer Institute
San Antonio, Texas, United States
Countries
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References
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Plummer R, Ghielmini M, Calvert P, Voi M, Renard J, Gallant G, Gupta E, Calvert H, Sessa C. Phase I and pharmacokinetic study of the new taxane analog BMS-184476 given weekly in patients with advanced malignancies. Clin Cancer Res. 2002 Sep;8(9):2788-97.
Hidalgo M, Aylesworth C, Hammond LA, Britten CD, Weiss G, Stephenson J Jr, Schwartz G, Patnaik A, Smith L, Molpus K, Felton S, Gupta E, Ferrante KJ, Tortora A, Sonnichsen DS, Skillings J, Rowinsky EK. Phase I and pharmacokinetic study of BMS-184476, a taxane with greater potency and solubility than paclitaxel. J Clin Oncol. 2001 May 1;19(9):2493-503. doi: 10.1200/JCO.2001.19.9.2493.
Other Identifiers
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UTHSC-9785011072
Identifier Type: -
Identifier Source: secondary_id
BMS-CA154-001
Identifier Type: -
Identifier Source: secondary_id
SACI-IDD-97-21
Identifier Type: -
Identifier Source: secondary_id
NCI-V98-1499
Identifier Type: -
Identifier Source: secondary_id
CDR0000066813
Identifier Type: -
Identifier Source: org_study_id