Clinical trial · Interventional
Sunitinib Malate in Treating Patients With Small Cell Lung Cancer
Phase II Study of Sunitinib (SU011248) in Patients With Small Cell Lung Cancer Who Are Either Chemo-naïve (Extensive Disease) or Have a "Sensitive" Relapse
NCT00953459CI-TRIAL-00034001terminatedPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): poorly recruiting
Summary
Brief summary (as posted)
RATIONALE: Sunitinib malate may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth and by blocking blood flow to the tumor. PURPOSE: This phase II trial is studying how well sunitinib malate works in treating patients with 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 |
|---|---|---|---|
| fludeoxyglucose F 18 | Radiation | — | UNRESOLVED |
| laboratory biomarker analysis | Other | — | UNRESOLVED |
| sunitinib malate | Drug | Sunitinib | ALIAS |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- Disease control rate (percentage of patients with complete response, partial response, or stable disease) 8 weeks after beginning treatment according to RECIST criteria
Secondary outcomes (6)
- measure
- Response rate every 4 weeks according to RECIST criteria
- measure
- Duration of progression-free survival
- measure
- Duration of response
- measure
- Duration of survival
- measure
- Toxicity according to NCI CTCAE version 3.0
- measure
- Accuracy of FDG-PET scan as a potential early surrogate marker of antiangiogenic activity for response
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 120 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS: * Histologically confirmed small cell lung cancer * Chemotherapy naïve (extensive stage) OR sensitive relapse (\> 3 months since induction therapy) disease * Measurable disease, as defined by RECIST criteria * No brain metastases as assessed by CT scan or MRI performed \< 1 week before treatment PATIENT CHARACTERISTICS: * WHO performance status 0-2 * Life expectancy \> 12 weeks * Absolute neutrophil count ≥ 1.5 x 10\^9/L * Platelet count ≥ 100 x 10\^9/L * AST and ALT ≤ 2.5 x upper limit of normal (ULN) (≤ 5 x ULN if liver function abnormalities are due to underlying malignancy) * Total serum bilirubin ≤ 1.5 x ULN * Serum albumin ≥ 3.0 g/dL * Negative pregnancy test * Not pregnant or nursing * Fertile patients must use effective contraception during and for 3 months after study treatment * No spinal cord compression, carcinomatous meningitis, or leptomeningeal disease * No myocardial infarction, severe/unstable angina, coronary/peripheral artery bypass graft, congestive heart failure, cerebrovascular accident including transient ischemic attack, or pulmonary embolus within the past 6 months * No NCI CTCAE grade 3 hemorrhage within the past 4 weeks * No hypertension (\> 150/100 mm Hg) that cannot be controlled with standard antihypertensive agents * No ongoing cardiac dysrhythmias of grade ≥ 2, atrial fibrillation of any grade, or QTc interval \> 450 msec for males or \> 470 msec for females * No other severe acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study drug administration or may interfere with the interpretation of study results, and, in the judgment of the investigator, would make the patient inappropriate for entry into this study * No psychological, familial, sociological, or geographical condition potentially hampering compliance with the study protocol and follow-up schedule PRIOR CONCURRENT THERAPY: * More than 4 weeks since prior chemotherapy, surgery, or investigational agents * At least 1 month since prior radiotherapy except for palliative radiotherapy to non-target lesions * No prior treatment with sunitinib malate (SU011248) or other receptor tyrosine kinase inhibitors * No concurrent treatment with steroids * No concurrent treatment with a drug having proarrhythmic potential (i.e., terfenadine, quinidine, procainamide, disopyramide, sotalol, probucol, bepridil, haloperidol, risperidone, indapamide and flecainide) * More than 7 and 12 days and no concurrent potent CYP3A4 inhibitors and inducers, respectively * Concurrent coumarin-derivative anticoagulants, such as warfarin (Coumadin®) up to 2 mg daily are permitted for prophylaxis of thrombosis * No other concurrent anticancer treatments, including chemotherapy, immunotherapy, targeted agents, hormonal cancer therapy, radiation therapy, or experimental treatments
References
Publications (0)
Data not yet available
No reference posted for this study.