Clinical trial · Interventional
Imatinib Mesylate After Irinotecan and Cisplatin in Treating Patients With Extensive-Stage Small Cell Lung Cancer
Phase II Trial of Imatinib Mesylate Maintenance Therapy in Patients With C-Kit (+) Extensive-Stage Small Cell Lung Cancer
- 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: Imatinib mesylate may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as irinotecan and cisplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more tumor cells. Giving imatinib mesylate after irinotecan and cisplatin may keep the tumor from coming back. PURPOSE: This phase II trial is studying how well giving imatinib mesylate after irinotecan and cisplatin works in treating patients with 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 |
| Gleevec™ | Drug | — | UNRESOLVED |
| irinotecan | Drug | Irinotecan | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Irinotecan, Cisplatin & Gleevec™
- description
- Cisplatin 60mg/m2 IV day 1 every 21 days x 4 cycles Gleevec™ 400 mg po BID (800mg/day)- for patients with objective response or stable disease. Irinotecan 65 mg/m2 IV days 1, 8 every 21 days x 4 cycles
- interventionNames
- Drug: Cisplatin
- Drug: Gleevec™
- Drug: irinotecan
Primary outcomes (1)
- measure
- Progression-free survival
- timeFrame
- at 4 months
Secondary outcomes (3)
- measure
- Overall survival
- timeFrame
- at least 4 months after discontinuation of treatment
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS:
* Histologically or cytologically confirmed small cell lung cancer (SCLC)
* Extensive stage disease, defined by 1 of the following criteria:
* Disease extends beyond one hemithorax and regional lymph nodes
* Cytologically positive pleural effusion
* Meets 1 of the following criteria:
* Measurable disease, defined as ≥ 1 unidimensionally measurable lesion outside the field of any prior radiotherapy
* Evaluable disease
* No history of untreated or symptomatic brain or leptomeningeal metastases
* Prior brain metastases allowed provided patient is neurologically stable for 2 weeks after completion of therapy
PATIENT CHARACTERISTICS:
Performance status
* SWOG 0-2
Life expectancy
* Not specified
Hematopoietic
* Absolute neutrophil count ≥ 1,500/mm\^3
* Platelet count ≥ 100,000/mm\^3
* Hemoglobin ≥ 8 g/dL
Hepatic
* Bilirubin ≤ 1.5 times upper limit of normal (ULN)
* Meets 1 of the following criteria:
* Alkaline phosphatase (AP) normal AND AST and ALT ≤ 2.5 times ULN
* AP ≤ 5 times ULN AND AST and ALT normal
* No acute or chronic liver disease (e.g., chronic active hepatitis or cirrhosis)
Renal
* Creatinine normal OR
* Creatinine clearance ≥ 65 mL/min
Cardiovascular
* No uncontrolled congestive heart failure
* No uncontrolled angina
* No myocardial infarction and/or stroke within the past 3 months
Other
* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective contraception during and for 3 months after completion of study treatment
* No peripheral neuropathy ≥ grade 2
* No symptomatic edema from any etiology
* No known HIV positivity
* No other serious medical illness
* No other malignancy within the past 3 years except adequately treated squamous cell or basal cell skin cancer or carcinoma in situ of the cervix
* No history of dementia, active psychiatric disorder, or other condition that would preclude study compliance or ability to take oral medication on a daily basis
PRIOR CONCURRENT THERAPY:
Chemotherapy
* No prior chemotherapy for SCLC
Endocrine therapy
* No concurrent routine systemic corticosteroids
Radiotherapy
* See Disease Characteristics
* At least 2 weeks since prior palliative radiotherapy
Surgery
* More than 2 weeks since prior major surgery
Other
* No concurrent therapeutic anticoagulation with warfarin
* Concurrent low molecular weight heparin allowed provided regimen was initiated ≥ 2 weeks prior to study entry
* No other concurrent participation in another study of an investigational agentReferences
Publications (0)
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