Status:
UNKNOWN
Second-line Therapy Study of Combined Chemotherapy and Endostar to Patients With Non-Small Cell Lung Cancer(NSCLC)
Lead Sponsor:
Simcere Pharmaceutical Co., Ltd
Conditions:
Advanced NSCLC
Recurrent NSCLC
Eligibility:
All Genders
18-75 years
Phase:
PHASE4
Brief 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, randomize...
Detailed Description
The combinative therapy of Endostar, Vinorelbine and cisplatin has been shown to increase response rate and survival in patients (pts) with advanced NSCLC and is sFDA-approved for this indication. How...
Eligibility Criteria
Inclusion
- Age 18-75 years old, males or females;
- 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;
- 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 );
- 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;
- Karnofsky performance scale≥60 or ECOG performance scale≤ 2; expected survival time≥3 months;
- No allergic history to biological agents and taxane agents;
- Patients are voluntary to participate and sign the informed contents.
Exclusion
- Pregnant or breast-feeding females; or females who have reproductive ability but do not take contraception method;
- With severe acute infection uncontrolled; purulent or chronic infection with wounds difficult to recover;
- 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;
- Patients with uncontrolled neurological, mental disease or psychosis, patients with poor compliance that cannot coordinate the therapy or describe the treatment response;
- Uncontrolled brain metastasis patients with obvious manifestations of intracranial hypertension or neurological and mental disorders;
- Uncontrolled diabetes and contraindication to corticoid agents;
- Obvious hemorrhage tendency;
- Allergic to any drug in the trial;
- Patients with a second tumor;
- Patients participating in other clinical trials;
- Patients treated by Endostar or Docetaxel (excluding neo-chemotherapy) included combination chemotherapy previously;
- Foci to be evaluated for response in trial treated by radiation in 6 months.
- Other conditions that are regarded for exclusion by the trialists.
Key Trial Info
Start Date :
October 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
October 1 2010
Estimated Enrollment :
300 Patients enrolled
Trial Details
Trial ID
NCT00813332
Start Date
October 1 2008
End Date
October 1 2010
Last Update
January 25 2010
Active Locations (1)
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1
Cancer Hospital of Tianjin Medical University
Tianjin, China, 300060