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Second-Line Therapy Study of Combined Chemotherapy and Endostar to Patients With Non-Small Cell Lung Cancer(NSCLC)
This study is currently recruiting participants.
Verified by Simcere Pharmaceutical Co., Ltd, January 2009
Sponsored by: Simcere Pharmaceutical Co., Ltd
Information provided by: Simcere Pharmaceutical Co., Ltd
ClinicalTrials.gov Identifier: NCT00813332
  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 IV

MedlinePlus related topics: Cancer
Drug Information available for: Docetaxel Endostatin
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator), Placebo Control, Parallel Assignment, Safety/Efficacy Study
Official Title: A Double Blind , Randomized, Multicenter Study of Second Line Treatment of Endostar(rh Recombined Endostatin)With Single Docetaxel In NSCLC Patients

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
1: Experimental
Endostar combined with Docetaxel
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.
2: Placebo Comparator
Docetaxel combined with placebo
Drug: Placebo plus Docetaxel
Placebo plus Docetaxel

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 and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Age > 18 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
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

Responsible Party: Cancer Hospital of Tianjin Medical University ( Kai LI/Professor )
Study ID Numbers: simcere002, simcere0802
Study First Received: December 19, 2008
Last Updated: January 7, 2009
ClinicalTrials.gov Identifier: NCT00813332  
Health Authority: China: State Food and Drug Administration;   United States: Institutional Review Board

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

Study placed in the following topic categories:
Docetaxel
Thoracic Neoplasms
Non-small cell lung cancer
Respiratory Tract Diseases
Lung Neoplasms
Lung Diseases
Endostatins
Carcinoma, Non-Small-Cell Lung
Recurrence
Neoplasms, Glandular and Epithelial
Carcinoma

Additional relevant MeSH terms:
Respiratory Tract Neoplasms
Neoplasms
Neoplasms by Site
Neoplasms by Histologic Type
Antineoplastic Agents
Growth Substances
Therapeutic Uses
Physiological Effects of Drugs
Growth Inhibitors
Angiogenesis Modulating Agents
Angiogenesis Inhibitors
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 13, 2009