Clinical trial NCT00453154 (phase 1/phase 2, status: completed)
Conditions: extensive stage lung small cell carcinoma, recurrent lung small cell carcinoma
ICD codes: D02.20, D02.21, D02.22, D02.20, D02.21, D02.22
Drugs: carboplatin, cisplatin, etoposide, sunitinib malate
SMILES: N[C@@H](CCCNC(N)=N)C(O)=O, [H][C@@]12N(C)C3=CC(OC)=C(C=C3[C@@]11CCN3CC=C[C@](CC)([C@@]13[H])[C@@]([H])(OC(C)=O)[C@]2(O)C(=O)OC)[C@]1(C[C@@]2([H])CN(CC(CC)=C2)CC2=C1NC1=CC=CC=C21)C(=O)OC, OCCOCCN1CCN(CC1)C(C1=CC=CC=C1)C1=CC=C(Cl)C=C1, CCN(CC)CCNC(=O)C1=C(C)NC(\C=C2/C(=O)NC3=C2C=C(F)C=C3)=C1C
Eligibility criteria:

        Inclusion Criteria:

          -  All patients must have histologically or cytologically documented small cell lung
             cancer

               -  Eligible disease stages: the extensive disease classification for this protocol
                  includes all patients with disease sites not defined as limited stage; limited
                  stage disease category includes patients with disease restricted to one
                  hemithorax with regional lymph node metastases, including hilar, ipsilateral and
                  contralateral mediastinal, and/or ipsilateral supraclavicular nodes; extensive
                  stage patients are defined as those patients with extrathoracic metastatic,
                  malignant pleural effusion, bilateral or contralateral supraclavicular adenopathy
                  or contralateral hilar adenopathy

          -  All patients must have measurable disease:

               -  Measurable disease is defined as at least one lesion that can be accurately
                  measured in at least one dimension (longest diameter to be recorded) as >= 20 mm
                  with conventional techniques or as >= 10 mm with spiral computed tomography (CT)
                  scan

               -  Lesions that are considered non-measurable, which would make the patient not
                  eligible, 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

          -  No prior chemotherapy for small cell lung cancer (SCLC)

          -  Radiation therapy must have been completed at least one week before initiation of
             protocol therapy

          -  Common Toxicity Criteria (CTC) performance status:

               -  Phase IB: 0-1

               -  Phase II: 0-2

          -  No "currently active" second malignancy other than non-melanoma skin cancers

          -  No history of brain metastases, spinal cord compression, or carcinomatous meningitis

          -  No ongoing cardiac dysrhythmias, atrial fibrillation, or QTc interval >= 500 msec; the
             use of agents with proarrhythmic potential (e.g., quinidine, procainamide,
             disopyramide, sotalol, probucol, pedridel, haloperidol, risperidone, indapamide,
             flecainide) is not recommended while on protocol therapy

          -  Patients with class I New York Heart Association (NYHA) are eligible; patients with a
             history of class II NYHA are eligible, provided they meet 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

          -  Additionally, no myocardial infarction, severe/unstable angina, coronary/peripheral
             artery bypass graft or stenting, cerebrovascular accident including transient ischemic
             attack, or pulmonary embolism 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 doses of coumarin-derivative anticoagulants
             such as warfarin are excluded, although doses of up to 2 mg daily are permitted for
             prophylaxis of thrombosis; Note: Low molecular weight heparin is permitted provided
             the patient's prothrombin time (PT) international normalized ratio (INR) is =< 1.5

          -  No evidence of hemoptysis within 4 weeks prior to starting study treatment; 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

          -  None of the following within 28 days of 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 there use
                  is discouraged

          -  Non-pregnant and non-nursing

          -  Granulocytes >= 1,500/ul

          -  Platelets >= 100,000/ul

          -  Creatinine clearance >= 70 ml/min

          -  Total bilirubin =< 1.5 mg/dl

          -  Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) =< 2.5 x upper
             limit of normal (ULN) (patients w/ liver metastases may have AST/ALT =< 5 x ULN)

          -  Partial thromboplastin time (PTT) =< 1.5 x ULN