Sunitinib Malate in Treating Patients With Small Cell Lung Cancer

NCT ID: NCT00953459

Last Updated: 2018-07-26

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE2
• Total Enrollment: 9 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-02-28
• Study Completion Date: 2012-09-30

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.

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.

Conditions

Lung Cancer

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Interventions

sunitinib malate

Intervention Type: DRUG

laboratory biomarker analysis

Intervention Type: OTHER

fludeoxyglucose F 18

Intervention Type: RADIATION

Eligibility Criteria

Inclusion Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 120 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

European Organisation for Research and Treatment of Cancer - EORTC

NETWORK

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Egbert F. Smit, MD

Role: PRINCIPAL_INVESTIGATOR

Free University Medical Center

Locations

Vrije Universiteit Medisch Centrum

Amsterdam, , Netherlands

Countries

Netherlands

Other Identifiers

EU-20910

Identifier Type: -

Identifier Source: secondary_id

2006-002485-19

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

EORTC-08061

Identifier Type: -

Identifier Source: org_study_id