Salvage Therapy With Sunitinib,Docetaxel and Platinum on Metastatic or Unresectable Non Small Cell Lung Cancer

This is an interventional treatment trial for Non Small Cell Lung Cancer focused on measuring non small cell lung cancer, sunitinib, docetaxel Read More

Inclusion Criteria:

1. Male or female,18 years of age or older.
2. Chemotherapy-naive patients with metastatic or unresectable non-small cell lung cancer.
3. Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0-1.
4. Normal left ventricular ejection fraction (LVEF).
5. At least one unidimensionally measurable lesion with a diameter > 10 mm using CT scan.
6. Life expectancy greater than 3 months.
7. Neutrophils 1,500/L, Platelets 100,000/L, AST/ALT 2.5 ULN (< 5 ULN if liver metastases), Alkaline phosphatase 2.5 ULN, Serum bilirubin 1.5 ULN, Serum Creatinine 1.5 ULN.
8. Urine dipstick of proteinuria <2+. Patients discovered to have 2+ proteinuria on dipstick urinalysis at baseline, should undergo a 24-hour urine collection and must demonstrate 1g of protein/24 hr.
9. Patients in this study should avoid having child. Women of childbearing potential must have a negative serum pregnancy test done 1 week prior to the administration of the study drug. She and her partner should prevent pregnancy (oral contraceptives, intrauterine contraceptive device, barrier method of contraception in conjunction with spermicidal jelly or surgically sterile) up to at least 6 months after last treatment completion or the last drug dose, whatever happens first.
10. Signed written informed consent according to ICH/GCP and the local regulations (approved by the Institutional Review Board [IRB]/Independent Ethics Committee [IEC]) will be obtained prior to any study specific screening procedures.
11. Patient must be able to comply with the protocol.

Exclusion Criteria:

1. Poor condition and inappropriate situation to enter this study, which could be determined by the principle investigator or in-charge attending physician.
2. Uncontrolled hypertension (systolic blood pressure > 160 mm Hg, diastolic blood pressure > 90 mm Hg).
3. Prior exposure to VEGF inhibitors.
4. Major surgical procedure, open biopsy or significant traumatic injury within 28 days prior to Day 0 (Patients must have recovered from any major surgery), or anticipation of need for major surgical procedure during the course of the study.
5. Planned radiotherapy for underlying disease (prior completed radiotherapy treatment allowed).
6. Clinical or radiological evidence of CNS metastases.
7. Serious non-healing wound or ulcer.
8. Evidence of bleeding diathesis or coagulopathy.
9. Clinically significant (i.e. active) cardiovascular disease for example cerebrovascular accidents (≤ 6 months), myocardial infarction (≤ 6 months), unstable angina, New York Heart Association (NYHA) grade II or greater congestive heart failure, serious cardiac arrhythmia requiring medication. Stroke in the preceding six months.
10. Current or recent (within 10 days prior to study treatment start) ongoing treatment with anticoagulants for therapeutic purposes i.e. except for anticoagulation for maintenance of potency of permanent indwelling IV catheters.
11. Evidence of other disease, metabolic dysfunction, physical examination finding, or clinical laboratory finding giving reasonable suspicion of a disease or condition that contraindicates use of an investigational drug or patient at high risk from treatment complications.
12. Ongoing treatment with large dose aspirin (> 325 mg/day) or other medications known to predispose to gastrointestinal ulceration (Continuous using NSAIDs).
13. Pregnancy (positive serum pregnancy test) and lactation.
14. Any other serious or uncontrolled illness which, in the opinion of the investigator, makes it undesirable for the patient to enter the trial.