Sunitinib Malate in Treating Patients With Small Cell Lung Cancer

Lung Cancer Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00953459
• Other study ID #: EORTC-08061
• Secondary ID: EU-209102006-002
• Status: Terminated
• Phase: Phase 2
• Start date: February 2009
• Est. completion date: September 2012

Study information

• Verified date: July 2018
• Source: European Organisation for Research and Treatment of Cancer - EORTC
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 9
• Est. completion date: September 2012
• Est. primary completion date: July 2010
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 120 Years

Eligibility

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

Related Conditions & MeSH terms

• Lung Cancer
• Lung Neoplasms
• Small Cell Lung Carcinoma

Intervention

Drug:
• sunitinib malate

Other:
• laboratory biomarker analysis

Radiation:
• fludeoxyglucose F 18

Locations

Country	Name	City	State
Netherlands	Vrije Universiteit Medisch Centrum	Amsterdam

Sponsors (1)

Lead Sponsor	Collaborator
European Organisation for Research and Treatment of Cancer - EORTC

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Disease control rate (percentage of patients with complete response, partial response, or stable disease) 8 weeks after beginning treatment according to RECIST criteria
Secondary	Response rate every 4 weeks according to RECIST criteria
Secondary	Duration of progression-free survival
Secondary	Duration of response
Secondary	Duration of survival
Secondary	Toxicity according to NCI CTCAE version 3.0
Secondary	Accuracy of FDG-PET scan as a potential early surrogate marker of antiangiogenic activity for response