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Imatinib Mesylate and Chemotherapy in Treating Patients With Extensive-Stage Small Cell Lung Cancer Clinical Trials Info presented on Clinical Trials Search isn't intended to be a substitute for certified medical advice, calls or professional assistance using a genuine dr.. We aren't physicians. Always confer with your dr. on Imatinib Mesylate and Chemotherapy in Treating Patients With Extensive-Stage Small Cell Lung Cancer conditions. Clinical Trials Search.org is a website committed to listing clinical research studies in human subjects. Imatinib Mesylate and Chemotherapy in Treating Patients With Extensive-Stage Small Cell Lung Cancer Clinical research trials and Imatinib Mesylate and Chemotherapy in Treating Patients With Extensive-Stage Small Cell Lung Cancer medical trials happen in hundreds of localities throughout the U.S.A.. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials typically measure the effectualness of new does drugs. The intent of the studies / undertakings is to answer particular human health questions. Clinical trials are a popular manner for physicians, government agencies, and private sector corporations to find cures for all kinds of circumstances, like Imatinib Mesylate and Chemotherapy in Treating Patients With Extensive-Stage Small Cell Lung Cancer. Imatinib Mesylate and Chemotherapy in Treating Patients With Extensive-Stage Small Cell Lung Cancer Clinical Trials and other clinical trials permit volunteers to acquire healthcare treatment options before they are available to the general public. Some times the subjects acquire professional assistance for free, and sometimes they are paid for their time. Sometimes there is a cost for a Imatinib Mesylate and Chemotherapy in Treating Patients With Extensive-Stage Small Cell Lung Cancer clinical trial. Participants frequently obtain the most expert healthcare available for their Imatinib Mesylate and Chemotherapy in Treating Patients With Extensive-Stage Small Cell Lung Cancer condition. Dangers are a reality, nevertheless, and can include more or frequent doctor calls, health risks (potentially life-jeopardizing), and/or the treatment being ineffectual. Trials are federally regulated with strict guidelines to protect clinical trials subjects.
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Home > "I" Clinical Trials Conditions > Imatinib Mesylate and Chemotherapy in Treating Patients With Extensive-Stage Small Cell Lung Cancer  Imatinib Mesylate and Chemotherapy in Treating Patients With Extensive-Stage Small Cell Lung Cancer
Imatinib Mesylate and Chemotherapy in Treating Patients With Extensive-Stage Small Cell Lung Cancer
For Condition: extensive stage small cell lung cancer
Status: Completed
Sponsor(s): Memorial Sloan-Kettering Cancer Center , National Cancer Institute (NCI)
Synopsis: RATIONALE: Imatinib mesylate may stop the growth of tumor cells by blocking the enzymes necessary for tumor cell growth. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining imatinib mesylate with chemotherapy may kill more tumor cells. PURPOSE: Phase I trial to study the effectiveness of combining imatinib mesylate with irinotecan and cisplatin in treating patients who have extensive-stage small cell lung cancer
Details: OBJECTIVES: - Determine the maximum tolerated dose of imatinib mesylate when administered with irinotecan and cisplatin in patients with extensive stage small cell lung cancer. - Determine the effect of imatinib mesylate on irinotecan metabolism by the cytochrome p450 system in these patients. - Determine the response rate, time to progression, and survival of patients treated with this regimen. OUTLINE: This is a dose-escalation study of imatinib mesylate. Patients receive irinotecan IV over 30 minutes on days 1, 8, and 15 and cisplatin IV over 60 minutes on day 1. Treatment repeats every 28 days for 4 courses in the absence of disease progression or unacceptable toxicity. Patients also receive oral imatinib mesylate once or twice daily beginning on day 22 of course 1 and continuing until disease progression or unacceptable toxicity. Cohorts of 3-6 patients receive escalating doses of imatinib mesylate until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which at least 2 of 3 or 2 of 6 patients experience dose-limiting toxicity. PROJECTED ACCRUAL: Approximately 18 patients will be accrued for this study within 12-18 months.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry Criteria: DISEASE CHARACTERISTICS: - Histologically confirmed small cell lung cancer - Extensive stage disease - Measurable or evaluable indicator lesion - No symptomatic or uncontrolled brain or leptomeningeal involvement PATIENT CHARACTERISTICS: Age - 18 and over Performance status - Karnofsky 70-100% Life expectancy - Not specified Hematopoietic - WBC at least 4,000/mm3 - Platelet count at least 160,000/mm3 - Hemoglobin at least 10 g/dL Hepatic - Bilirubin no greater than 1 mg/dL - AST no greater than 2.5 times upper limit of normal (ULN) - Alkaline phosphatase no greater than 5 times ULN Renal - Creatinine less than 1.5 mg/dL OR - Creatinine clearance at least 50 mL/min Cardiovascular - No symptomatic congestive heart failure - No unstable angina pectoris - No uncontrolled cardiac arrhythmia Other - Not pregnant or nursing - Negative pregnancy test - Fertile patients must use effective barrier contraception during and for 3 months after study - No other active cancer except previously treated carcinoma in situ, non -melanoma skin cancer, or stage I prostate cancer - No ongoing or active infection - No psychiatric illness or social situation that would preclude study - No other concurrent uncontrolled illness PRIOR CONCURRENT THERAPY: Biologic therapy - Not specified Chemotherapy - No prior chemotherapy except for non-cancer conditions (e.g., low-dose methotrexate for rheumatoid arthritis) Endocrine therapy - Not specified Radiotherapy - At least 2 weeks since prior radiotherapy to major bone marrow-containing areas Surgery - Not specified Other - No concurrent warfarin for therapeutic anticoagulation - Low-molecular weight heparin or heparin allowed
Total Enrollment:
Location and Contact Information:
Overall Study Official:
LeeKrug, Study Chair, Memorial Sloan-Kettering Cancer Center
Memorial Sloan-Kettering Cancer Center
New York City, New York, 10021
United States
Additional Information:
Study ID Numbers: CDR0000256923; NCI-5653,MSKCC-02015
Study Start Date:
Record last reviewed: April 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00045604
Other Extensive Stage Small Cell Lung Cancer Studies:
1. Combination Chemotherapy and Imatinib Mesylate in Treating Patients With Extensive-Stage Small Cell Lung Cancer
2. Cisplatin, Etoposide, and Bevacizumab in Treating Patients With Previously Untreated Extensive-Stage Small Cell Lung Cancer
3. Bortezomib in Treating Patients With Recurrent or Refractory Extensive-Stage Small Cell Lung Cancer Previously Treated With Platinum-Based Chemotherapy
4. Combination Chemotherapy in Treating Patients With Extensive-Stage Small Cell Lung Cancer
5. Phase I/II Study of Lepirudin in Patients with Recurrent or Extensive Stage Small Cell Lung Cancer
Related Studies:
Other extensive stage small cell lung cancer Clinical Trials
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Imatinib Mesylate and Chemotherapy in Treating Patients With Extensive-Stage Small Cell Lung Cancer
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