Clinical trial NCT00698815 (phase 2, status: completed)
Conditions: recurrent non-small cell lung carcinoma, stage iiib non-small cell lung cancer ajcc v7, stage iv non-small cell lung cancer ajcc v7
ICD codes: D02.20, D02.21, D02.22, C78.00, C78.01, C78.02, D14.30, D14.31, D14.32, C34.2
Drugs: pemetrexed disodium, sunitinib malate
SMILES: [H][C@@](CCC(O)=O)(NC(=O)C1=CC=C(CCC2=CNC3=C2C(O)=NC(=N)N3)C=C1)C(O)=O, CCN(CC)CCNC(=O)C1=C(C)NC(\C=C2/C(=O)NC3=C2C=C(F)C=C3)=C1C
Eligibility criteria:

        Inclusion Criteria:

          -  Histologic documentation: histologic or cytologic documentation of NSCLC

          -  Stage: IIIB/IV with evidence of disease progression following first-line therapy

          -  Tumor site: lung (non-small cell)

          -  No cavitary lesions

          -  Only one prior chemotherapy regimen in the first-line stage IIIB/IV setting is
             allowed; this could have been either a platinum- or non-platinum-based regimen

          -  First-line therapy must be completed >= 28 days before registration

          -  Prior adjuvant therapy is allowed provided the patient had one previous regimen in the
             advanced stage IIIB/IV setting

          -  At least 28 days from prior major surgery and at least 14 days from any prior
             radiotherapy before registration

          -  No prior inhibitors of VEGF receptor (VEGFR) (e.g., SU5416, SU6668, AZ6474, SU11248,
             PTK787, AZD2171, AEE-788, sorafenib); prior treatment with epidermal growth factor
             receptor (EGFR) inhibitors and bevacizumab is allowed, provided at least 4 weeks has
             elapsed

          -  No prior pemetrexed

          -  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
                       nonmeasurable 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 0-1

          -  Pregnant or nursing mothers are not eligible for this study; patients in their child
             bearing years must have a baseline negative pregnancy test (in the case of females);
             males and females must practice appropriate contraceptive measures during the period
             of protocol therapy and for 6 months after completion of protocol therapy; appropriate
             methods of birth control include abstinence, oral contraceptives, implantable hormonal
             contraceptives (Norplant), or double barrier method (diaphragm plus condom)

          -  No ongoing cardiac dysrhythmias, atrial fibrillation, or history of corrected QT
             interval (QTc interval) > 500 msec (within 2 years prior to registration); the use of
             agents with proarrhythmic potential (e.g., quinidine, procainamide, disopyramide,
             sotalol, probucol, bepridil, 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 symptomatic congestive heart failure within 12 months prior
             to entry 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 or hyperthyroidism 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 use of the following specific inhibitors and inducers of cytochrome P450, family
             3, subfamily A, polypeptide 4 (CYP3A4) is not permitted; the following inhibitors of
             CYP3A4 are prohibited within 7 days before 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

          -  No symptomatic or untreated central nervous system (CNS) metastases; patients with 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 chronic daily treatment with aspirin (> 325 mg/day) or non-steroidal
             antiinflammatory agents known to inhibit platelet function; treatment with
             dipyridamole (Persantine), ticlopidine (Ticlid), clopidogrel (Plavix) and/or
             cilostazol (Pletal) is not allowed

          -  No pleural effusions or ascites that are detectable on physical exam