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

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.

Study Overview

• Status: Terminated
• Conditions: Lung Cancer
• Intervention / Treatment: Other: laboratory biomarker analysis; Radiation: fludeoxyglucose F 18; Drug: sunitinib malate

Detailed Description

OBJECTIVES:

Primary

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

Secondary

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

Tertiary

• 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
• Enrollment (Actual): 9
• Phase: Phase 2

Contacts and Locations

Study Locations

• Netherlands
  • Amsterdam, Netherlands, 1007 MB
    • Vrije Universiteit Medisch Centrum

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 120 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NON_RANDOMIZED
• Interventional Model: SINGLE_GROUP
• Masking: NONE

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Duration of response
Duration of survival
Response rate every 4 weeks according to RECIST criteria
Duration of progression-free survival
Toxicity according to NCI CTCAE version 3.0
Accuracy of FDG-PET scan as a potential early surrogate marker of antiangiogenic activity for response

Collaborators and Investigators

• Sponsor: European Organisation for Research and Treatment of Cancer - EORTC
• Investigators: Principal Investigator: Egbert F. Smit, MD, Free University Medical Center

Study record dates

Study Major Dates

• Study Start: February 1, 2009
• Primary Completion (ACTUAL): July 1, 2010
• Study Completion (ACTUAL): September 1, 2012

Study Registration Dates

• First Submitted: August 5, 2009
• First Submitted That Met QC Criteria: August 5, 2009
• First Posted (ESTIMATE): August 6, 2009

Study Record Updates

• Last Update Posted (ACTUAL): July 26, 2018
• Last Update Submitted That Met QC Criteria: July 25, 2018
• Last Verified: July 1, 2018

More Information

Terms related to this study

• Keywords: extensive stage small cell lung cancer; recurrent small cell lung cancer
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Neoplasms; Lung Diseases; Neoplasms by Site; Respiratory Tract Neoplasms; Thoracic Neoplasms; Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Small Cell Lung Carcinoma; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Antineoplastic Agents; Angiogenesis Inhibitors; Angiogenesis Modulating Agents; Growth Substances; Growth Inhibitors; Radiopharmaceuticals; Protein Kinase Inhibitors; Fluorodeoxyglucose F18; Sunitinib
• Other Study ID Numbers: EORTC-08061; EU-20910; 2006-002485-19 (EUDRACT_NUMBER)