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

Sponsor

Simcere Pharmaceutical Co., Ltd (Other)

Overall Status

Unknown status

CT.gov ID

NCT00813332

Collaborator

(none)

300

Enrollment

Location

Arms

Duration (Months)

12.5

Patients Per Site Per Month

Study Details

Study Description

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, randomized controlled, phase Ⅳ clinical trial for NSCLC cases who have obvious progressive disease or intolerant adverse effects in first-line chemotherapy.

Condition or Disease	Intervention/Treatment	Phase
Advanced NSCLC Recurrent NSCLC	Drug: Endostar(rh recombinant endostatin) plus Docetaxel Drug: Placebo plus Docetaxel	Phase 4

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. However, there are limited data on the safety and efficacy of Endostar in combination with other widely used chemotherapy doublets for NSCLC. Clinical data proved that Endostar was a wild spectrum and safe antiangiogenesis factor which could suppress almost 65 kinds of tumor mass in animal models and affect about 12 percent human genome. In this clinical trial, there will be 160 patients enrollment, giving Docetaxel (75mg/m2,iv, d1, every 3 weeks) plus Endostar(7.5mg/m2/day, iv, d1-d14, every 3 weeks) or Docetaxel with placebo. We'll evaluate the efficacy and safety of the Docetaxel plus Endostar treatment to NSCLC and hope to provide a promising regimen to advanced lung cancer patients.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

300 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Triple (Participant, Care Provider, Investigator)

Primary Purpose:

Treatment

Official Title:

A Double Blind , Randomized, Multicenter Study of Second Line Treatment of Endostar（rh Recombined Endostatin）With Single Docetaxel In NSCLC Patients

Study Start Date :

Oct 1, 2008

Anticipated Primary Completion Date :

Oct 1, 2009

Anticipated Study Completion Date :

Oct 1, 2010

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 1 Endostar combined with Docetaxel for Advanced NSCLC: All eligible patients will receive Endostar in combination with Docetaxel chemotherapy for 2 cycles (21 days for each cycle) and cases of good response(CR+PR+SD) will continue treatment for 2 cycles. Endostar treatment will continue after completion of first 4 cycles until disease progression.	Drug: Endostar(rh recombinant endostatin) plus Docetaxel 7.5mg/m2, IV( in the vein) on day1-14 of each 21-28 day cycle. Number of cycles: until progression or unacceptable toxicity develops. Other Names: Experimental group
Placebo Comparator: 2 Docetaxel combined with placebo for Advanced NSCLC: All eligible patients will receive placebo in combination with Docetaxel chemotherapy for 2 cycles (21 days for each cycle) and cases of good response(CR+PR+SD) will continue treatment for 2 cycles. Placebo will continue after completion of first 4 cycles until disease progression.	Drug: Placebo plus Docetaxel Placebo plus Docetaxel Other Names: control group

Arm

Intervention/Treatment

Experimental: 1

Endostar combined with Docetaxel for Advanced NSCLC: All eligible patients will receive Endostar in combination with Docetaxel chemotherapy for 2 cycles (21 days for each cycle) and cases of good response(CR+PR+SD) will continue treatment for 2 cycles. Endostar treatment will continue after completion of first 4 cycles until disease progression.

Drug: Endostar(rh recombinant endostatin) plus Docetaxel

7.5mg/m2, IV( in the vein) on day1-14 of each 21-28 day cycle. Number of cycles: until progression or unacceptable toxicity develops.

Other Names:

Experimental group

Placebo Comparator: 2

Docetaxel combined with placebo for Advanced NSCLC: All eligible patients will receive placebo in combination with Docetaxel chemotherapy for 2 cycles (21 days for each cycle) and cases of good response(CR+PR+SD) will continue treatment for 2 cycles. Placebo will continue after completion of first 4 cycles until disease progression.

Drug: Placebo plus Docetaxel

Placebo plus Docetaxel

Other Names:

control group

Outcome Measures

Primary Outcome Measures

Progression-free survival time,survival rate for 1 year [two years (2010.10)]

Secondary Outcome Measures

Tumor response rate, disease controlled rate and adverse effects. [1 year (2009.10)]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 75 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

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 Criteria:

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.