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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified December 2009 by Simcere Pharmaceutical Co., Ltd.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Simcere Pharmaceutical Co., Ltd
ClinicalTrials.gov Identifier:
NCT00813332
First received: December 19, 2008
Last updated: January 22, 2010
Last verified: December 2009
  Purpose

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 Intervention Phase
Advanced NSCLC
Recurrent NSCLC
Drug: Endostar(rh recombinant endostatin) plus Docetaxel
Drug: Placebo plus Docetaxel
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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

Resource links provided by NLM:


Further study details as provided by Simcere Pharmaceutical Co., Ltd:

Primary Outcome Measures:
  • Progression-free survival time,survival rate for 1 year [ Time Frame: two years (2010.10) ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Tumor response rate, disease controlled rate and adverse effects. [ Time Frame: 1 year (2009.10) ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 300
Study Start Date: October 2008
Estimated Study Completion Date: October 2010
Estimated Primary Completion Date: October 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: 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 Name: control group

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.

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00813332

Contacts
Contact: Kai LI, Professor 0086-22-81351613 likai5@medmail.com.cn, likqupp@yahoo.com
Contact: Zhao YAN, Doctor 0086-22-23948638 yanzhaotj@126.com

Locations
China
Cancer Hospital of Tianjin Medical University Recruiting
Tianjin, China, 300060
Contact: Kai LI, Professor    0086-22-81351613    likai5@medmail.com.cn,likqupp@yahoo.com   
Contact: Zhao YAN, Doctor    0086-22-23948638(Fax23524155)    yanzhaotj@126.com   
Principal Investigator: Kai LI, Professor         
Sponsors and Collaborators
Simcere Pharmaceutical Co., Ltd
Investigators
Principal Investigator: Kai LI, professor Cancer Hospital of Tianjin Medical University
  More Information

No publications provided

Responsible Party: Kai LI/Professor, Cancer Hospital of Tianjin Medical University
ClinicalTrials.gov Identifier: NCT00813332     History of Changes
Other Study ID Numbers: simcere002, simcere0802
Study First Received: December 19, 2008
Last Updated: January 22, 2010
Health Authority: China: Food and Drug Administration
United States: Institutional Review Board

Keywords provided by Simcere Pharmaceutical Co., Ltd:
Endostar
NSCLC
Docetaxel
Combined therapy
second-line chemotherapy

Additional relevant MeSH terms:
Carcinoma, Non-Small-Cell Lung
Bronchial Neoplasms
Carcinoma, Bronchogenic
Lung Diseases
Lung Neoplasms
Neoplasms
Neoplasms by Site
Respiratory Tract Diseases
Respiratory Tract Neoplasms
Thoracic Neoplasms
Docetaxel
Endostatins
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Antimitotic Agents
Antineoplastic Agents
Growth Inhibitors
Growth Substances
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses
Tubulin Modulators

ClinicalTrials.gov processed this record on October 29, 2014