Clinical trial NCT00953459: Sunitinib Malate in Treating Patients With Small Cell Lung Cancer
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
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Lung Cancer
Keywords: extensive stage small cell lung cancer
recurrent small cell lung cancer
Lead sponsor: European Organisation for Research and Treatment of Cancer - EORTC
Sponsor class: NETWORK
First posted: 2009-08-06
Enrollment: 9
Sex: ALL
Minimum age (years): 18
Maximum age (years): 120
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility 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

Primary outcomes:
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 outcomes:
measure: Response rate every 4 weeks according to RECIST criteria
measure: Duration of progression-free survival
measure: Duration of response
measure: Duration of survival
measure: Toxicity according to NCI CTCAE version 3.0
measure: Accuracy of FDG-PET scan as a potential early surrogate marker of antiangiogenic activity for response
Other outcomes:
Locations:
city: Amsterdam
country: Netherlands
facility: Vrije Universiteit Medisch Centrum
Study officials:
affiliation: Free University Medical Center
name: Egbert F. Smit, MD
role: PRINCIPAL_INVESTIGATOR
References: