Curative Effect Study of Endostatin Combined With Chemoradiotherapy to Non-small-cell Lung Cancer

Phase I/II Clinical Trial of Recombinant Human Endostatin in Combination With Concurrent Chemo-Radiotherapy in the Patients With Unresectable Stage III Non-small-Cell Lung Cancer

Sponsors

Lead Sponsor: Sun Yat-sen University

Collaborator: The Affiliated Hospital of Guangdong Medical College
Fujian Province Tumor Hospital
Fifth Affiliated Hospital, Sun Yat-Sen University
The Affiliated Tumor Hospital of Guangxi Medical University
Zhejiang Cancer Hospital
Guangzhou General Hospital of Guangzhou Military Command
The 458 Hospital of Chinese PLA

Source Sun Yat-sen University
Brief Summary

To evaluate the efficacy and safety of Endostar combined with concurrent chemo-radiotherapy (CCRT) in patients with unresectable stage III non-small-cell lung cancer (NSCLC).

Detailed Description

OBJECTIVES: Primary:To assess the treatment response rate (RR) of Endostar in combination with CCRT Secondary - The progression-free survival (PFS) - The overall survival(OS). - The failed treatment modality. - The toxicity of this regimen. OUTLINE CCRT:Patients receive chemotherapy comprising Docetaxel(65mg/m2,iv gtt duration>1h) and Cisplatin(65mg/m2,concurrent hydration) on days 1 and 29 and at least 3 hours after chemotherapy undergo concurrent 3D-CRT five days a week for total dose 60-66Gy. Endostatin:Patients receive Endostatin 7.5mg/m2 daily by iv gtt up to 7 days consecutively 1 week before radiotherapy and repeat every 2 weeks. Patients are seen in follow-up every 3 months for 2 years and then every 6 months thereafter. Physical examination and CT scans of the thorax and upper abdomen are performed routinely.

Overall Status Unknown status
Start Date May 2009
Completion Date December 2015
Primary Completion Date December 2013
Phase Phase 2
Study Type Interventional
Primary Outcome
Measure Time Frame
Response Rate (RR) 4 weeks after CCRT
Enrollment 50
Condition
Intervention

Intervention Type: Drug

Intervention Name: Endostatin

Description: 7.5mg/m2,iv gtt daily up to 7 days,beginning 1 week before radiotherapy,and repeat every 2 weeks

Arm Group Label: Endostatin combine CCRT

Other Name: Endostar

Eligibility

Criteria:

Inclusion Criteria: - 18 years of age - untreated pathologically confirmed inoperable stage IIIA or IIIB NSCLC - weight loss of less than 10% in the past 6 months - performance status (PS) of 0 to 1 - forced vital capacity in 1 second (FEV1) higher than 0.8 L - measurable disease by Response Evaluation Criteria in Solid Tumors (RECIST). - absolute neutrophil count (ANC) of ≥ 1500/μL - hemoglobin ≥ 10 mg/dL - platelet ≥ 100,000/μL - serum creatinine ≤ 1.25 times of upper limit of normal (ULN) - calculated creatinine clearance (CrCl) of ≥ 60 ml/min - bilirubin 1.5×ULN - AST and ALT less than 2.5×ULN - alkaline phosphatase less than 5×ULN. Exclusion Criteria: - active infection - history of significant cardiac disease (unstable angina, congestive heart failure, myocardial infarction within the previous 6 months, ventricular arrhythmias) - malnutrition (loss of ≥ 20% of the original body weight) - sensor or motor neuropathy > grade I - second primary malignancy, except for non-melanoma skin cancer - psychiatric illness or social situation that would preclude study compliance - pregnant or lactating women - preexisting bleeding diatheses or coagulopathy - Prior chemotherapy,chest irradiation therapy, or therapy directed at the epidermal growth factor receptor pathway

Gender: All

Minimum Age: 18 Years

Maximum Age: 75 Years

Healthy Volunteers: No

Overall Official
Last Name Role Affiliation
Ming Chen, Doctor Study Chair Sun Yat-sen University
Location
Facility: Sun Yat-Sen University Cancer Center
Location Countries

China

Verification Date

August 2012

Responsible Party

Type: Principal Investigator

Investigator Affiliation: Sun Yat-sen University

Investigator Full Name: Ming Chen

Investigator Title: Professor

Keywords
Has Expanded Access No
Condition Browse
Number Of Arms 1
Arm Group

Label: Endostatin combine CCRT

Type: Experimental

Description: 7.5mg/m2,iv gtt daily up to 7 days,beginning 1 week before radiotherapy,and repeat every 2 weeks

Acronym DP-EN-RT
Study Design Info

Allocation: N/A

Intervention Model: Single Group Assignment

Primary Purpose: Treatment

Masking: None (Open Label)

Source: ClinicalTrials.gov