Sunitinib Malate in Treating Patients With Small Cell Lung Cancer

NCT00953459 | Terminated Phase 2

• 3 other identifiers: EORTC-08061EU-209102006-002485-19
• Study Type: interventional
• Target: 9
• Locations: 1 country
• Sites: 1

Brief Summary

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

Lung Cancer

Keywords

extensive stage small cell lung cancer; recurrent small cell lung cancer

Outcome Measures

Primary Outcomes (1)

• 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)

• Response rate every 4 weeks according to RECIST criteria

• Duration of progression-free survival

• Duration of response

• Duration of survival

• Toxicity according to NCI CTCAE version 3.0

Interventions

sunitinib malate DRUG

laboratory biomarker analysis OTHER

fludeoxyglucose F 18 RADIATION

Eligibility Criteria

• Age: 18 Years - 120 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• European Organisation for Research and Treatment of Cancer - EORTC: lead

Study Sites (1)

Vrije Universiteit Medisch Centrum

Amsterdam, 1007 MB, Netherlands

Location

MeSH Terms

Conditions

Lung Neoplasms; Small Cell Lung Carcinoma

Interventions

Sunitinib; Fluorodeoxyglucose F18

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases; Carcinoma, Bronchogenic; Bronchial Neoplasms

Intervention Hierarchy (Ancestors)

Pyrroles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Deoxyglucose; Deoxy Sugars; Carbohydrates

Study Officials

• Egbert F. Smit, MD

  Free University Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 5, 2009
• First Posted: August 6, 2009
• Study Start: February 1, 2009
• Primary Completion: July 1, 2010
• Study Completion: September 1, 2012
• Last Updated: July 26, 2018

Record last verified: 2018-07

Locations

NL (1)