Basic Trial Information
|Phase III||Treatment||Closed||18 and over||NCI||NCI-2009-00469|
CDR0000597649, CALGB 30607, U10CA180821, U10CA031946, NCT00693992
This randomized phase III trial studies sunitinib malate to see how well it works when given as maintenance therapy (meaning it is approved for treatment after chemotherapy) in patients with stage IIIB-IV non-small cell lung cancer who have responded to prior treatment with combination chemotherapy. Sunitinib malate may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth and by blocking the growth of new blood vessels necessary for tumor growth. It is not yet known whether sunitinib malate is effective in helping tumors continue to shrink or stop growing.
Further Study Information
I. To evaluate the effect of sunitinib (sunitinib malate) compared to placebo on progression-free survival (PFS) in advanced non-small cell lung cancer (NSCLC) patients who have had either stable or responding disease over the course of their initial 4 cycles of platinum-based therapy.
I. To evaluate the toxicity of sunitinib compared to placebo in the maintenance setting.
II. To evaluate the additional response rate as a result of sunitinib in this setting.
III. To assess the impact of sunitinib on overall survival compared to the placebo arm.
IV. To assess the impact of sunitinib on delaying the time to deterioration in quality of life and symptom progression compared to placebo using the European Organization for Research and Treatment of Cancer (EORTC) Core Quality of Life Questionnaire (QLQ-C30) and Lung Cancer Module (LC13).
V. To assess vascular endothelial growth factor (VEGF) haplotypes in advanced non-small cell lung cancer and sunitinib maintenance.
OUTLINE: Patients are randomized to 1 of 2 treatment arms.
ARM I: Patients receive sunitinib malate orally (PO) once daily (QD) on days 1-21. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
ARM II: Patients receive placebo PO QD on days 1-21. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed up every 3 months for 1 year, every 6 months for 1 year, and then periodically for 3 years.
- Histologic or cytologic documentation of primary non-small cell lung cancer
- Stage IIIB or IV disease patients who are not candidates for combined modality therapy (chemoradiotherapy)
- No evidence of symptomatic or untreated brain metastases, spinal cord compression, or carcinomatous meningitis; patients with central nervous system (CNS) metastases must be asymptomatic, must have received definitive therapy (>= 6 weeks since resection or >= 2 weeks since radiotherapy) for brain metastases, and be off steroids or on a stable dose for 2 weeks prior to registration
- Patients must have received one chemotherapy regimen for stage IIIB or IV NSCLC; the regimen must include four cycles of platinum-based doublet chemotherapy with or without bevacizumab (bevacizumab may not be given beyond the fourth cycle of chemotherapy); patients must have achieved a complete response, partial response, or stable disease to first-line chemotherapy and have no evidence of disease progression; patients will be registered 3-5 weeks following day 1 of cycle 4 of prior therapy
- No prior adjuvant chemotherapy for stage I-III resected NSCLC or combined modality therapy for stage III NSCLC
- No other primary therapy (including experimental therapy) for NSCLC; palliative radiation therapy must have been completed at least one week before planned start of protocol therapy
- Patients must have measurable or non-measurable disease
- Measurable disease: lesions that can be accurately measured in at least one dimension (longest diameter to be recorded) as >= 2 cm with conventional techniques or as >= 1 cm with spiral computed tomography (CT) scan
- Non-measurable disease: all other lesions, including small lesions (longest diameter < 20 mm with conventional techniques or < 10 mm with spiral CT scan) and truly non-measurable lesions; lesions that are considered non-measurable include the following:
- Pleural/pericardial effusion
- Lymphangitis cutis/pulmonis
- Abdominal masses that are not confirmed and followed by imaging techniques
- Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1
- Non-pregnant and non-nursing
- No ongoing cardiac dysrhythmias, atrial fibrillation, or history of corrected QT (QTc) interval >= 500 msec (within 2 years prior to registration); the use of agents with proarrhythmic potential (e.g., quinidine, procainamide, disopyramide, sotalol, probucol, haloperidol, risperidone, indapamide, flecainide) is not recommended while on protocol therapy
- Patients with class I New York Heart Association (NYHA) heart failure are eligible; patients with a history of class II NYHA heart failure are eligible, provided they meet at least one of the following criteria:
- Patients with a history of class II heart failure who are asymptomatic on treatment
- Patients with prior anthracycline exposure
- Patients who have received central thoracic radiation that included the heart in the radiotherapy port
- Patients with a history of class III or IV NYHA heart failure within 12 months prior to registration are not eligible
- No myocardial infarction, severe/unstable angina, coronary/peripheral artery bypass graft or stenting, cerebrovascular accident or transient ischemic attack within the last year
- Patients with hypertension that cannot be controlled by medications (> 150/100 mmHg despite optimal medical therapy) are not eligible
- Patients who require use of therapeutic anticoagulation for thromboembolic disease are not eligible; Note: low doses of coumadin (up to 2 mg daily) are permitted for prophylaxis of thrombosis
- No history of venous thrombosis, pulmonary embolism, or hypercoagulopathy syndrome
- No history of pulmonary hemorrhage, bleeding diathesis, or evidence of hemoptysis; patients with blood-tinged or blood-streaked sputum will be permitted on study if the hemoptysis amounts to less than 5 ml of blood per episode and less than 10 ml of blood per 24-hour period in the best estimate of the investigator
- Patients with a history of hypothyroidism are eligible, provided they are currently euthyroid
- None of the following within 28 days of beginning treatment: abdominal fistula, gastrointestinal perforation, intra-abdominal abscess, serious or non-healing wound, ulcer, or bone fracture
- The following inhibitors of cytochrome P450 3A4 (CYP3A4) are prohibited within 7 days before beginning and during treatment with sunitinib: azole antifungals (ketoconazole, itraconazole), diltiazem, clarithromycin, erythromycin, verapamil, delavirdine, and human immunodeficiency virus [HIV] protease inhibitors (indinavir, saquinavir, ritonavir, atazanavir, nelfinavir); the following inducers of CYP3A4 are prohibited within 12 days before beginning and during treatment with sunitinib: rifampin, rifabutin, carbamazepine, phenobarbital, phenytoin, St. John's Wort, efavirenz, tipranavir; other inhibitors and inducers of CYP3A4 may be used if necessary, but their use is discouraged
- Patients unable to take oral medication are not eligible
- Granulocytes >= 1,500/mcl
- Platelet count >= 100,000/mcl
- Total bilirubin =< 1.5 x upper limit of normal (ULN)
- Aspartate aminotransferase (AST) and alanine aminotransferase (ALT)=< 2.5 x ULN; patients with liver metastases may have AST and ALT =< 5 x ULN; all other patients will have AST and ALT =< 2.5 x ULN
Trial Lead Organizations/Sponsors
National Cancer Institute
Mark Socinski, Principal Investigator
Kaiser Permanente Medical Center - Los Angeles
Han A Koh
Feather River Hospital Cancer Center
Kaiser Permanente - Mission
Han A Koh
Helen and Harry Gray Cancer Center at Hartford Hospital
Robert D. Siegel
Broward General Medical Center Cancer Center
Barry S Berman
Saint Anthony's Hospital at Saint Anthony's Health Center
Bethany G. Sleckman
Fort Wayne Medical Oncology and Hematology
Sreenivasa Rao Nattam
St. Vincent Indianapolis Hospital
Ruemu E Birhiray
Sturdy Memorial Hospital
Colleen K Yavarow
Immanuel St. Joseph's
Mohmmad J Ranginwala
CCOP - St. Louis-Cape Girardeau
Bethany G. Sleckman
Siteman Cancer Center at Barnes-Jewish Hospital - Saint Louis
Maria Q. Baggstrom
Center for Cancer Care at Exeter Hospital
Michael S Buff
Bassett Healthcare Regional Cancer Program at Mary Imogene Bassett Hospital
Charles R. Wood Cancer Center at Glens Falls Hospital
Aqeel A Gillani
Bismarck Cancer Center
Edward J. Wos
McDowell Cancer Center at Akron General Medical Center
Esther H. Rehmus
Mercy Cancer Center at Mercy Medical Center
Stephenson Cancer Center at the University of Oklahoma
Salem Hospital Regional Cancer Care Services
Edward Peter Orlowski
Sanford Cancer Center at Sanford USD Medical Center
Miroslaw A Mazurczak
Miroslaw A Mazurczak
Ben Taub General Hospital
Martha P Mims
Dan L. Duncan Cancer Center at Baylor College of Medicine
Martha P Mims
St. Luke's Texas Cancer Institute at St. Luke's Episcopal Hospital
Martha P Mims
Veterans Affairs Medical Center - Houston
Martha P Mims
Gundersen Lutheran Center for Cancer and Blood
Link to the current ClinicalTrials.gov record.
NLM Identifier NCT00693992
ClinicalTrials.gov processed this data on May 25, 2015
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