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BMS-188797 and Carboplatin in Treating Patients With Advanced Nonhematologic Cancer Clinical Trials Data presented on Clinical Trials Search isn't meant to be a substitute for qualified health advice, calls or treatment using a genuine doctor. We are not docs. Always consult your dr. on BMS-188797 and Carboplatin in Treating Patients With Advanced Nonhematologic Cancer conditions. Clinical Trials Search.org is a site dedicated to listing clinical research studies in human subjects. BMS-188797 and Carboplatin in Treating Patients With Advanced Nonhematologic Cancer Clinical research trials and BMS-188797 and Carboplatin in Treating Patients With Advanced Nonhematologic Cancer healthcare trials occur in a lot of of places throughout the United States. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials generally assess the potency of new drugs. The intent of the studies / undertakings is to figure out certain human medical questions. Clinical trials are a popular means for mDs, government agencies, and private sector corporations to locate remedies for all kinds of circumstances, including BMS-188797 and Carboplatin in Treating Patients With Advanced Nonhematologic Cancer. BMS-188797 and Carboplatin in Treating Patients With Advanced Nonhematologic Cancer Clinical Trials and other clinical trials allow volunteers to obtain health treatment alternatives before they are available to the masses. Many times the participants undergo treatment for free, and sometimes they are paid for their time. Occasionally there is a cost for a BMS-188797 and Carboplatin in Treating Patients With Advanced Nonhematologic Cancer clinical trial. Participants typically obtain the most effective healthcare available for their BMS-188797 and Carboplatin in Treating Patients With Advanced Nonhematologic Cancer condition. Dangers are a reality, nonetheless, and can include extra or frequent mD trips, medical hazards (potentially life-endangering), and/or the treatment being uneffective. Trials are federally regulated with rigid guidelines to protect clinical trials patients.
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Home > "B" Clinical Trials Conditions > BMS-188797 and Carboplatin in Treating Patients With Advanced Nonhematologic Cancer  BMS-188797 and Carboplatin in Treating Patients With Advanced Nonhematologic Cancer
BMS-188797 and Carboplatin in Treating Patients With Advanced Nonhematologic Cancer
For Condition: unspecified adult solid tumor, protocol specific
Status: No longer recruiting
Sponsor(s): National Cancer Institute (NCI) , H. Lee Moffitt Cancer Center and Research Institute
Synopsis: 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 .
Details: OBJECTIVES: I. 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. II. Assess the dose limiting toxicities and safety of this treatment regimen in these patients. III. Determine the plasma pharmacokinetics of this treatment regimen in these patients. IV. Determine any antitumor activity of this treatment regimen in these patients. PROTOCOL 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.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/
Genders:
Protocol Entry Criteria: PROTOCOL ENTRY 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 --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 --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/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 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
Total Enrollment:
Location and Contact Information:
Overall Study Official:
DanielSullivan, Study Chair, H. Lee Moffitt Cancer Center and Research Institute
H. Lee Moffitt Cancer Center and Research Institute
Tampa, Florida, 33612-9497
United States
Additional Information:
Study ID Numbers: CDR0000068078; NCI-G00-1825,MCC-12176,BMS-CA159-003
Study Start Date: June 2000
Record last reviewed: May 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00006086
Other Unspecified Adult Solid Tumor, Protocol Specific Studies:
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2. Irinotecan in Treating Patients With Advanced Solid Tumors
3. Epirubicin Plus Irinotecan in Treating Patients With Advanced Cancer
4. Study to Assess Cancer Patients' Satisfaction With Hospital Quality of Care
5. Modafinil in Treating Fatigue in Patients Receiving Chemotherapy for Cancer
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BMS-188797 and Carboplatin in Treating Patients With Advanced Nonhematologic Cancer
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