Sunitinib as a Second-line Treatment for Patients With Recurrent Small Cell Lung Cancer

• Status: Completed
• Trial end date: 2012-09-01
• Target enrollment: 0
• Participant gender: All

Summary

the investigators will conduct a phase II trial to evaluate the efficacy and toxicity of Sunitinib in patients with recurrent SCLC.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: National Cancer Center, Korea
• Collaborator: Pfizer
• Treatments: Sunitinib

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