Second-line Therapy Study of Combined Chemotherapy and Endostar to Patients With Non-Small Cell Lung Cancer(NSCLC)

• Status: Unknown status
• Trial end date: 2010-10-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to compare the efficacy and safety of Endostar (Recombinant Human Endostatin) combined with Docetaxel and single Docetaxel through multi-center, double-blinding, randomized controlled, phase Ⅳ clinical trial for NSCLC cases who have obvious progressive disease or intolerant adverse effects in first-line chemotherapy.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Simcere Pharmaceutical Co., Ltd
• Treatments: Docetaxel; Endostar protein; Endostatins

Criteria

Inclusion Criteria:

1. Age 18-75 years old, males or females;

2. Patients with NSCLC confirmed by histopathology or cytology who need second-line chemotherapy, including progressive disease cases during or in 3 months posterior to end of first-line chemotherapy( at least 4 cycles done) and cases with intolerant adverse effects in first-line chemotherapy( at least 4 cycles done); neo-adjuvant chemotherapy and targeted therapy(EFGR-TKIs) not to be served as first-line chemotherapy; 3 months of clearance needed for neo-adjuvant chemotherapy and 1 month for targeted and first-line chemotherapy;

3. Local advanced and metastatic cases with tumor foci that can be evaluated by CT, MRI or PET-CT; at least one diameter ≥ 1 cm (including metastatic lymph nodes) confirmed by CT scan or ≥ 1 cm by spin CT or PET-CT );

4. No contraindication for chemotherapy, with normal peripheral hemogram, renal and hepatic function: Peripheral hemogram: WBC≥4.0×109/L，PLT≥80×109/L，Hgb≥90g/L； Renal function: serum BUN and creatinine ≤1.0×UNL; Hepatic function: transaminase≤1.5×UNL, BIL≤×UNL;

5. Karnofsky performance scale≥60 or ECOG performance scale≤ 2; expected survival time≥3 months;

6. No allergic history to biological agents and taxane agents;

7. Patients are voluntary to participate and sign the informed contents.

Exclusion Criteria:

1. Pregnant or breast-feeding females; or females who have reproductive ability but do not take contraception method;

2. With severe acute infection uncontrolled; purulent or chronic infection with wounds difficult to recover;

3. With history of severe heart diseases, including congestive heart failure, uncontrolled arrhythmia with high risk, unstable angina pectoris, myocardial infarction, severe cardiac valvular diseases and refractory hypertension;

4. Patients with uncontrolled neurological, mental disease or psychosis, patients with poor compliance that cannot coordinate the therapy or describe the treatment response;

5. Uncontrolled brain metastasis patients with obvious manifestations of intracranial hypertension or neurological and mental disorders;

6. Uncontrolled diabetes and contraindication to corticoid agents;

7. Obvious hemorrhage tendency;

8. Allergic to any drug in the trial;

9. Patients with a second tumor;

10. Patients participating in other clinical trials;

11. Patients treated by Endostar or Docetaxel (excluding neo-chemotherapy) included combination chemotherapy previously;

12. Foci to be evaluated for response in trial treated by radiation in 6 months.

13. Other conditions that are regarded for exclusion by the trialists.