Overview
Second-line Therapy Study of Combined Chemotherapy and Endostar to Patients With Non-Small Cell Lung Cancer(NSCLC)
Status:
Unknown status
Unknown status
Trial end date:
2010-10-01
2010-10-01
Target enrollment:
0
0
Participant gender:
All
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 4Accepts Healthy Volunteers?
NoDetails
Lead Sponsor:
Simcere Pharmaceutical Co., LtdTreatments:
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.