Clinical trial NCT00620347 (phase 2, status: completed)
Conditions: lung cancer
ICD codes: C78.00, C78.01, C78.02, D14.30, D14.31, D14.32, C34.2
Drugs: sunitinib
SMILES: CNC(=O)C1=C(SC2=CC=C3C(NN=C3\C=C\C3=CC=CC=N3)=C2)C=CC=C1
Eligibility criteria:

        Inclusion Criteria:

          1. Histologic or cytologic confirmed SCLC

          2. Clinically diagnosed ED-SCLC according to sixth Edition of the AJCC cancer staging
             manual

          3. Progression during or after prior first line chemotherapy.

          4. Resolution of all acute toxic effects of prior therapy or surgical procedure to grade
             ≤ 1 (except alopecia)

          5. Prior radiation therapy excluded lung is allowed.

          6. No other forms of cancer therapy, such as chemotherapy, radiation, immunotherapy for
             at least 3 weeks before the enrollment in study.

          7. Performance status of 0, 1, 2 on the ECOG criteria.

          8. Tumor work-up: within 4weeks prior 1st day of treatment: chest X-ray; CT of chest,
             liver, and adrenal glands; bone scan; brain MRI

          9. At least one uni-dimensionally measurable lesion meeting Response Evaluation Criteria
             in Solid Tumors.

         10. Estimated life expectancy of at least 12 weeks.

         11. Patient compliance that allows adequate follow-up.

         12. Adequate organ function for chemotherapy

         13. Adequate cardiac function: normal EF by Echocardiography

         14. No ischemic heart disease or cardiac dysrhythmia.

         15. Normal QTc interval

         16. Normal thyroid function.

         17. Informed consent from patient or patient's relative.

         18. Males or females at least 18 years of age.

         19. If female: childbearing potential either terminated by surgery, radiation, or
             menopause, or attenuated by use of an approved contraceptive method (intrauterine
             device [IUD], birth control pills, or barrier device) during and for 3 months after
             trial. If male, use of an approved contraceptive method during the study and 3 months
             afterwards. Females with childbearing potential must have a urine negative HCG test
             within 7 days prior to the study enrollment.

        Exclusion Criteria:

          1. Diagnosis of any second malignancy within the past 3 years, except basal cell
             carcinoma, squamous cell skin cancer, or in situ carcinoma that has been adequately
             treated with no evidence or recurrent disease for 12 months

          2. NCI CTCAE grade ≥ 2 neuropathy from any cause

          3. Ongoing treatment with therapeutic doses of coumarin derivatives, such as warfarin,
             (low dose Coumadin® up to 2 mg PO daily for deep vein thrombosis prophylaxis is
             allowed)

          4. Uncontrolled brain metastases, spinal cord compression, carcinomatous meningitis, or
             leptomeningeal disease. Patients should have completed surgery or radiation therapy
             for existing brain metastases, should not have documented increase in size over the
             previous 3 months and should be asymptomatic off steroids

          5. Any of the following within the 12 months prior to starting study treatment:
             myocardial infarction, sever/unstable angina, coronary/peripheral artery bypass graft,
             congestive heart failure, cerebrovascular accident including transient ischemic
             attack, or pulmonary embolus

          6. NCI CTCAE Grade 3 hemorrhage < 4 weeks of starting study treatment

          7. Hypertension (>150/100 mg Hg) that cannot be controlled with standard antihypertensive
             agents

          8. Ongoing cardiac dysrhythmias of grade ≥ 2, atrial fibrillation of any grade, or QTc
             interval > 450 msec for males or > 470 msec for female

          9. Known human immunodeficiency virus (HIV) seropositivity

         10. Pregnancy or breastfeeding. All female patients with reproductive potential must have
             a negative pregnancy test (serum or urine) within 7 days prior to enrolment

         11. Other severe acute or chronic medical or psychiatric condition, or laboratory
             abnormality that may increase the risk associated with study participation or 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