Clinical trial · Interventional
Combination Chemotherapy and Imatinib Mesylate in Treating Patients With Extensive-Stage Small Cell Lung Cancer
A Phase I Study Of STI 571 (Gleevec) In Combination With Cisplatin/Irinotecan In Patients With Extensive Stage Small Cell Lung Cancer
NCT00052494CI-TRIAL-00018621completedPhase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Lung Cancer | Malignant Lung Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| cisplatin | Drug | Cisplatin | ALIAS |
| imatinib mesylate | Drug | Imatinib Mesylate | ALIAS |
| irinotecan hydrochloride | Drug | Irinotecan | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- STI-571 with cisplatin and irinotecan
- interventionNames
- Drug: cisplatin
- Drug: imatinib mesylate
- Drug: irinotecan hydrochloride
Primary outcomes (0)
[]Eligibility
Eligibility (as posted)
- Sex
- All
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.