Imatinib Mesylate and Chemotherapy in Treating Patients With Extensive-Stage Small Cell Lung Cancer
A Phase I Study of Imatinib (Gleevec) in Combination With Irinotecan and Cisplatin in Extensive Stage Small Cell Lung Cancer
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
Studieoversikt
Status
Forhold
Intervensjon / Behandling
Detaljert beskrivelse
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.
Studietype
Fase
- Fase 1
Kontakter og plasseringer
Studiesteder
-
-
New York
-
New York, New York, Forente stater, 10021
- Memorial Sloan-Kettering Cancer Center
-
-
Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Beskrivelse
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
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
Samarbeidspartnere og etterforskere
Samarbeidspartnere
Etterforskere
- Studiestol: Lee M. Krug, MD, Memorial Sloan Kettering Cancer Center
Studierekorddatoer
Studer hoveddatoer
Studiestart
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Anslag)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Anslag)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
- Sykdommer i luftveiene
- Neoplasmer
- Lungesykdommer
- Neoplasmer etter nettsted
- Neoplasmer i luftveiene
- Thoracale neoplasmer
- Karsinom, bronkogent
- Bronkiale neoplasmer
- Lungeneoplasmer
- Småcellet lungekarsinom
- Molekylære mekanismer for farmakologisk virkning
- Enzymhemmere
- Antineoplastiske midler
- Topoisomerasehemmere
- Proteinkinasehemmere
- Topoisomerase I-hemmere
- Irinotekan
- Imatinibmesylat
Andre studie-ID-numre
- CDR0000256923
- MSKCC-02015
- NCI-5653
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