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Combination Chemotherapy and Imatinib Mesylate 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 health advice, travels to or treatment by using a genuine physician. We are not physicians. Always consult your dr. on Combination Chemotherapy and Imatinib Mesylate in Treating Patients With Extensive-Stage Small Cell Lung Cancer conditions. Clinical Trials Search.org is a site committed to listing clinical research studies in human subjects. Combination Chemotherapy and Imatinib Mesylate in Treating Patients With Extensive-Stage Small Cell Lung Cancer Clinical research trials and Combination Chemotherapy and Imatinib Mesylate in Treating Patients With Extensive-Stage Small Cell Lung Cancer health trials occur in hundreds of cities 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 assess the effectivity of new drugs. The propose of the studies / undertakings is to resolve certain human health questions. Clinical trials are a popular means for physicians, government agencies, and private sector companies to locate treatments for all sorts of conditions, including Combination Chemotherapy and Imatinib Mesylate in Treating Patients With Extensive-Stage Small Cell Lung Cancer. Combination Chemotherapy and Imatinib Mesylate in Treating Patients With Extensive-Stage Small Cell Lung Cancer Clinical Trials and other clinical trials permit volunteers to acquire medical treatment choices before they are available to the masses. Some times the test subjects obtain professional assistance for free, and every now and again they are compensated for their time. Sometimes there is a cost for a Combination Chemotherapy and Imatinib Mesylate in Treating Patients With Extensive-Stage Small Cell Lung Cancer clinical trial. Participants oftentimes recieve the most expert healthcare available for their Combination Chemotherapy and Imatinib Mesylate in Treating Patients With Extensive-Stage Small Cell Lung Cancer condition. Hazards are a reality, however, and can include extra or frequent physician visits, health risks (potentially life-endangering), and/or the treatment being uneffective. Trials are federally governed with rigorous guidelines to protect clinical trials subjects.
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Home > "C" Clinical Trials Conditions > Combination Chemotherapy and Imatinib Mesylate in Treating Patients With Extensive-Stage Small Cell Lung Cancer  Combination Chemotherapy and Imatinib Mesylate in Treating Patients With Extensive-Stage Small Cell Lung Cancer
Combination Chemotherapy and Imatinib Mesylate in Treating Patients With Extensive-Stage Small Cell Lung Cancer
For Condition: extensive stage small cell lung cancer,Recurrent Small Cell Lung Cancer
Status: Recruiting
Sponsor(s): Princess Margaret Hospital , National Cancer Institute (NCI)
Synopsis: RATIONALE: Drugs used in chemotherapy work in different ways to stop tumor cells from dividing so they stop growing or die. Imatinib mesylate may stop the growth of tumor cells by blocking the enzymes necessary for their growth. Combining more than one chemotherapy drug with imatinib mesylate may kill more tumor cells. PURPOSE: Phase I trial to study the effectiveness of combining cisplatin, irinotecan, and imatinib mesylate in treating patients who have extensive-stage small cell lung cancer.
Details: OBJECTIVES: - Determine the maximum tolerated dose of imatinib mesylate when administered with cisplatin and irinotecan in patients with extensive stage small cell lung cancer. - Determine the recommended phase II dose of imatinib mesylate in patients treated with this regimen. - Determine the response rate, median duration of response, progression-free survival, median survival, and overall survival of patients treated with this regimen. OUTLINE: This is a multicenter, dose-escalation study of imatinib mesylate. Patients receive cisplatin IV over 1 hour on day 1 and irinotecan IV over 60 minutes on days 1, 8, and 15. Treatment repeats every 28 days for a maximum of 4 courses. Patients also receive oral imatinib mesylate daily continually for one week prior to, during, and after chemotherapy in the absence of 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 at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity. Once the MTD is determined, additional patients are treated at the recommended phase II dose (one dose level below the MTD). PROJECTED ACCRUAL: A total of 12-24 patients will be accrued for this study within 1-2 years.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: /
Genders: Both
Protocol Entry Criteria: DISEASE CHARACTERISTICS: - Histologically confirmed extensive stage small cell lung cancer - Incurable but amenable to treatment with chemotherapy - c-kit positive by immunohistochemistry of original biopsy or other metastatic site - At least one unidimensionally measurable lesion - > 20 mm by conventional techniques or > 10 mm by spiral CT scan - No prior radiotherapy to target measurable lesion(s), unless there is documented disease progression - No known brain metastases PATIENT CHARACTERISTICS: Age - Not specified Performance status - ECOG 0-1 OR - Karnofsky 70-100% Life expectancy - More than 6 weeks Hematopoietic - WBC 3,000/mm^3 - Absolute neutrophil count 1,500/mm^3 - Platelet count 100,000/mm^3 Hepatic - Bilirubin normal - AST and/or ALT 2.5 times upper limit of normal Renal - Creatinine normal OR - Creatinine clearance 60 mL/min Cardiovascular - No symptomatic congestive heart failure - No unstable angina pectoris - No cardiac arrhythmia Gastrointestinal - No concurrent untreated upper gastrointestinal bleeding that has not been fully investigated - No gastrointestinal disease that would impair drug absorption Other - Not pregnant or nursing - Negative pregnancy test - Fertile patients must use effective barrier contraception prior to, during, and for 3 months after study participation - No history of ototoxicity - No history of peripheral neuropathy - No traumatic injury within the past 21 days - No ongoing or active infection - No other concurrent significant medical condition that would preclude study participation - No concurrent psychiatric condition or social situation that would preclude study compliance - No other malignancy within the past 5 years except treated nonmelanoma skin cancer, carcinoma in situ, or stage A prostate cancer PRIOR CONCURRENT THERAPY: Biologic therapy - Not specified Chemotherapy - See Disease Characteristics - No prior chemotherapy - No other concurrent chemotherapy Endocrine therapy - Not specified Radiotherapy - See Disease Characteristics - More than 4 weeks since prior radiotherapy - No prior radiotherapy to more than 25% of marrow Surgery - More than 3 weeks since prior major surgery - No prior surgical procedure impairing absorption Other - No prior c-kit-targeted therapy - No concurrent therapeutic dose of warfarin - Mini-dose warfarin for prophylaxis and low-molecular weight heparin allowed - No concurrent combination antiretroviral therapy for HIV-positive patients - No other concurrent investigational agents - No concurrent amifostine - No other concurrent anticancer therapy
Total Enrollment:
Location and Contact Information:
Overall Study Official:
MarkVincent, Study Chair, Cancer Care Ontario-London Regional Cancer Centre
Princess Margaret Hospital *Recruiting*
Toronto, Ontario, M5G 2M9
Canada
Recruiting Natasha Leighl 416-946-2399
Additional Information:
Study ID Numbers: CDR0000258487; PMH-PHL-008,NCI-5684
Study Start Date:
Record last reviewed: March 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00052494
Other Recurrent Small Cell Lung Cancer Studies:
1. Combination Chemotherapy in Treating Patients With Extensive-Stage Small Cell Lung Cancer
2. Radiation Therapy in Preventing Brain Metastases in Patients With Small Cell Lung Cancer
3. Paclitaxel in Treating Patients With Extensive-Stage Small Cell Lung Cancer
4. Combination Chemotherapy in Treating Patients With Extensive-Stage Small Cell Lung Cancer
5. Chloroquinoxaline Sulfonamide in Treating Patients With Small Cell Lung Cancer
Related Studies:
Other Recurrent Small Cell Lung Cancer Clinical Trials
Other Ontario Clinical Trials
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Combination Chemotherapy and Imatinib Mesylate in Treating Patients With Extensive-Stage Small Cell Lung Cancer
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