Sunitinib Malate in Treating Patients With Small Cell Lung Cancer
Primary Purpose
Lung Cancer
Status
Terminated
Phase
Phase 2
Locations
Netherlands
Study Type
Interventional
Intervention
sunitinib malate
laboratory biomarker analysis
fludeoxyglucose F 18
Sponsored by
About this trial
This is an interventional treatment trial for Lung Cancer focused on measuring extensive stage small cell lung cancer, recurrent small cell lung cancer
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
Sites / Locations
- Vrije Universiteit Medisch Centrum
Outcomes
Primary Outcome Measures
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
Response rate every 4 weeks according to RECIST criteria
Duration of progression-free survival
Duration of response
Duration of 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
Full Information
NCT ID
NCT00953459
First Posted
August 5, 2009
Last Updated
July 25, 2018
Sponsor
European Organisation for Research and Treatment of Cancer - EORTC
1. Study Identification
Unique Protocol Identification Number
NCT00953459
Brief Title
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
2. Study Status
Record Verification Date
July 2018
Overall Recruitment Status
Terminated
Why Stopped
poorly recruiting
Study Start Date
February 2009 (undefined)
Primary Completion Date
July 2010 (Actual)
Study Completion Date
September 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
European Organisation for Research and Treatment of Cancer - EORTC
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lung Cancer
Keywords
extensive stage small cell lung cancer, recurrent small cell lung cancer
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
9 (Actual)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
sunitinib malate
Intervention Type
Other
Intervention Name(s)
laboratory biomarker analysis
Intervention Type
Radiation
Intervention Name(s)
fludeoxyglucose F 18
Primary Outcome Measure Information:
Title
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 Measure Information:
Title
Response rate every 4 weeks according to RECIST criteria
Title
Duration of progression-free survival
Title
Duration of response
Title
Duration of survival
Title
Toxicity according to NCI CTCAE version 3.0
Title
Accuracy of FDG-PET scan as a potential early surrogate marker of antiangiogenic activity for response
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
120 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Egbert F. Smit, MD
Organizational Affiliation
Free University Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Vrije Universiteit Medisch Centrum
City
Amsterdam
ZIP/Postal Code
1007 MB
Country
Netherlands
12. IPD Sharing Statement
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Sunitinib Malate in Treating Patients With Small Cell Lung Cancer
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