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

Primary Purpose

Advanced NSCLC, Recurrent NSCLC

Status

Unknown status

Phase

Phase 4

Locations

China

Study Type

Interventional

Intervention

Endostar(rh recombinant endostatin) plus Docetaxel

Placebo plus Docetaxel

About this trial

This is an interventional treatment trial for Advanced NSCLC focused on measuring Endostar, NSCLC, Docetaxel, Combined therapy, second-line chemotherapy

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

Cancer Hospital of Tianjin Medical UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Progression-free survival time,survival rate for 1 year

Secondary Outcome Measures

Tumor response rate, disease controlled rate and adverse effects.

Full Information

NCT ID

NCT00813332

First Posted

December 19, 2008

Last Updated

January 22, 2010

Sponsor

Simcere Pharmaceutical Co., Ltd

1. Study Identification

Unique Protocol Identification Number

NCT00813332

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

December 2009

Overall Recruitment Status

Unknown status

Study Start Date

October 2008 (undefined)

Primary Completion Date

October 2009 (Anticipated)

Study Completion Date

October 2010 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor

Simcere Pharmaceutical Co., Ltd

4. Oversight

Data Monitoring Committee

5. 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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Advanced NSCLC, Recurrent NSCLC

Keywords

Endostar, NSCLC, Docetaxel, Combined therapy, second-line chemotherapy

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigator

Allocation

Randomized

Enrollment

300 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Arm Type

Experimental

Arm Description

Arm Title

Arm Type

Placebo Comparator

Arm Description

Intervention Type

Drug

Intervention Name(s)

Endostar(rh recombinant endostatin) plus Docetaxel

Other Intervention Name(s)

Experimental group

Intervention Description

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.

Intervention Type

Drug

Intervention Name(s)

Placebo plus Docetaxel

Other Intervention Name(s)

control group

Intervention Description

Placebo plus Docetaxel

Primary Outcome Measure Information:

Title

Progression-free survival time,survival rate for 1 year

Time Frame

two years (2010.10)

Secondary Outcome Measure Information:

Title

Tumor response rate, disease controlled rate and adverse effects.

Time Frame

1 year (2009.10)

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

Eligibility Criteria

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.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Kai LI, Professor

Phone

0086-22-81351613

likai5@medmail.com.cn, likqupp@yahoo.com

First Name & Middle Initial & Last Name or Official Title & Degree

Zhao YAN, Doctor

Phone

0086-22-23948638

yanzhaotj@126.com

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Kai LI, professor

Organizational Affiliation

Cancer Hospital of Tianjin Medical University

Official's Role

Principal Investigator

Facility Information:

Facility Name

Cancer Hospital of Tianjin Medical University

City

Tianjin

ZIP/Postal Code

300060

Country

China

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Kai LI, Professor

Phone

0086-22-81351613

likai5@medmail.com.cn,likqupp@yahoo.com

First Name & Middle Initial & Last Name & Degree

Zhao YAN, Doctor

Phone

0086-22-23948638(Fax23524155)

yanzhaotj@126.com

First Name & Middle Initial & Last Name & Degree

Kai LI, Professor

12. IPD Sharing Statement

Learn more about this trial

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

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