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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

Phase 2
18 Years
Not Enrolling
Lung Cancer

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Trial Information

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



- 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

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.

Inclusion Criteria


- 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

- 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

- 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,

- 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

Type of Study:


Study Design:

Allocation: Non-Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Disease control rate (percentage of patients with complete response, partial response, or stable disease) 8 weeks after beginning treatment according to RECIST criteria

Safety Issue:


Principal Investigator

Egbert F. Smit, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Free University Medical Center


United States: Federal Government

Study ID:




Start Date:

February 2009

Completion Date:

September 2012

Related Keywords:

  • Lung Cancer
  • extensive stage small cell lung cancer
  • recurrent small cell lung cancer
  • Lung Neoplasms
  • Small Cell Lung Carcinoma