Sunitinib Malate as Maintenance Therapy in Treating Patients With Stage III or Stage IV Non-Small Cell Lung Cancer Previously Treated With Combination Chemotherapy
Condition: Stage IIIB Lung Non-Small Cell Cancer AJCC v7; Stage IV Non-Small Cell Lung Cancer AJCC v7
MeSH terms: Lung Neoplasms; Carcinoma, Non-Small-Cell Lung
Intervention: Laboratory Biomarker Analysis; Placebo; Quality-of-Life Assessment; Sunitinib Malate
Intervention description: Correlative studies; Given PO; Ancillary studies; Given PO
Intervention MeSH terms: Sunitinib
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 210.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      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.
    

Eligibility criteria:

        Inclusion Criteria:

          -  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

          -  No cavitary lesions

          -  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:

                    -  Bone lesions

                    -  Leptomeningeal disease

                    -  Ascites

                    -  Pleural/pericardial effusion

                    -  Lymphangitis cutis/pulmonis

                    -  Abdominal masses that are not confirmed and followed by imaging techniques

                    -  Cystic lesions

          -  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

          -  Creatinine =< 1.5 mg/dl