Sunitinib Malate in Treating Patients With Small Cell Lung Cancer

European Organisation for Research and Treatment of Cancer (EORTC)

Status and phase

Terminated

Phase 2

Conditions

Lung Cancer

Treatments

Drug: sunitinib malate

Other: laboratory biomarker analysis

Radiation: fludeoxyglucose F 18

Study type

Interventional

Funder types

NETWORK

Identifiers

NCT00953459

EU-20910

2006-002485-19 (EudraCT Number)

EORTC-08061

Details and patient eligibility

About

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.

Full 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.

Enrollment

9 patients

Sex

All

Ages

18 to 120 years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion 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