Sunitinib Malate in Treating Patients With Small Cell Lung Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00953459
Recruitment Status : Terminated (poorly recruiting)
First Posted : August 6, 2009
Last Update Posted : January 15, 2013
Information provided by (Responsible Party):
European Organisation for Research and Treatment of Cancer - EORTC

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.

Condition or disease Intervention/treatment Phase
Lung Cancer Drug: sunitinib malate Other: laboratory biomarker analysis Radiation: fludeoxyglucose F 18 Phase 2

Detailed Description:



  • To assess the therapeutic activity of sunitinib malate in patients with either chemonaïve extensive stage or sensitive relapsed small cell lung cancer.


  • To characterize the safety of sunitinib malate in these patients.


  • To determine the potential of FDG-PET-scan to serve as a surrogate marker of response for the antiangiogenic activity of the compound.

OUTLINE: This is a multicenter study. Patients are stratified according to disease stage (chemonaïve extensive stage vs sensitive relapse at least 3 months after stopping chemotherapy).

Patients receive oral sunitinib malate once daily for up to 1 year in the absence of disease progression or unacceptable toxicity.

Patients undergo fludeoxyglucose F 18 positron emission tomography of the chest at week 4. Blood samples and bronchial washings and brushings may be collected at baseline and at 4 and 8 weeks after start of therapy for further analysis.

After completion of study treatment, patients are followed up every 3 months.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 9 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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
Study Start Date : February 2009
Actual Primary Completion Date : July 2010
Actual Study Completion Date : September 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lung Cancer

Primary Outcome Measures :
  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 Outcome Measures :
  1. Response rate every 4 weeks according to RECIST criteria
  2. Duration of progression-free survival
  3. Duration of response
  4. Duration of survival
  5. Toxicity according to NCI CTCAE version 3.0
  6. Accuracy of FDG-PET scan as a potential early surrogate marker of antiangiogenic activity for response

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No


  • 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


  • 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


  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00953459

Vrije Universiteit Medisch Centrum
Amsterdam, Netherlands, 1007 MB
Sponsors and Collaborators
European Organisation for Research and Treatment of Cancer - EORTC
Principal Investigator: Egbert F. Smit, MD Free University Medical Center

Responsible Party: European Organisation for Research and Treatment of Cancer - EORTC Identifier: NCT00953459     History of Changes
Other Study ID Numbers: EORTC-08061
2006-002485-19 ( EudraCT Number )
First Posted: August 6, 2009    Key Record Dates
Last Update Posted: January 15, 2013
Last Verified: January 2013

Keywords provided by European Organisation for Research and Treatment of Cancer - EORTC:
extensive stage small cell lung cancer
recurrent small cell lung cancer

Additional relevant MeSH terms:
Lung Neoplasms
Small Cell Lung Carcinoma
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms
Fluorodeoxyglucose F18
Antineoplastic Agents
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Growth Inhibitors
Molecular Mechanisms of Pharmacological Action