Clinical trial · Interventional
Imatinib Mesylate in Treating Patients With Recurrent Small Cell Lung Cancer
Phase II Trial of STI571 in Patients With Relapsed Small Cell Lung Cancer
NCT00052949CI-TRIAL-00012350completedPhase 2ClinicalTrials.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)
Phase II trial to study the effectiveness of imatinib mesylate in treating patients who have recurrent small cell lung cancer. Imatinib mesylate may stop the growth of cancer cells by blocking the enzymes necessary for cancer cell growth.
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 |
|---|---|---|---|
| Recurrent Small Cell Lung Cancer | Lung Small Cell Carcinoma | CURATED_BROADER | 0.78 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| imatinib mesylate | Drug | Imatinib Mesylate | ALIAS |
| laboratory biomarker analysis | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Treatment (imatinib mesylate)
- description
- Patients receive oral imatinib mesylate twice daily for 28 days. Courses continue in the absence of disease progression or unacceptable toxicity.
- interventionNames
- Drug: imatinib mesylate
- Other: laboratory biomarker analysis
Primary outcomes (1)
- measure
- The proportion of patients progression-free
- timeFrame
- 16 weeks
- description
- Ninety-five percent confidence intervals for the true success proportion will be calculated according to the approach of Duffy and Santner.
Secondary outcomes (5)
- measure
- Survival time
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Histologically or cytologically confirmed small cell lung cancer (SCLC) * No mixed histology * Must have received only 1 prior treatment regimen (e.g., cyclophosphamide, doxorubicin, and vincristine alternating with etoposide and cisplatin allowed) * c-Kit positive by immunohistochemistry (at least 1+) * At least 1 unidimensionally measurable lesion * Longest diameter at least 20 mm * No uncontrolled CNS metastasis * Treated CNS metastasis allowed * Performance status - ECOG 0-2 * Absolute neutrophil count at least 1,500/mm\^3 * Platelet count at least 100,000/mm\^3 * Hemoglobin at least 9 g/dL * Total bilirubin no greater than 1.5 times upper limit of normal (ULN) * Direct bilirubin no greater than ULN * Creatinine no greater than 1.5 times ULN * No unstable angina pectoris * No uncontrolled congestive heart failure within the past 3 months unless ejection fraction is greater than 40% * No myocardial infarction within the past 3 months * No uncontrolled infection * No other malignancy within the past 3 years except skin cancer or localized prostate cancer * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception during and for at least 3 months after study participation * See Disease Characteristics * More than 3 weeks since prior chemotherapy * More than 2 weeks since prior radiotherapy * No concurrent radiotherapy(including palliative therapy for bone pain) * Concurrent whole-brain radiotherapy for CNS progression allowed * More than 3 weeks since prior major surgery * No prior imatinib mesylate
References
Publications (0)
Data not yet available
No reference posted for this study.