Overview

This trial is active, not recruiting.

Condition non-small cell lung cancer
Treatment endostatin
Phase phase 2
Target VEGF
Sponsor Sun Yat-sen University
Collaborator Guangdong Medical College
Start date May 2009
End date December 2013
Trial size 50 participants
Trial identifier NCT01218594, DP-EN-RT

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).

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Endpoint classification efficacy study
Intervention model single group assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
7.5mg/m2,iv gtt daily up to 7 days,beginning 1 week before radiotherapy,and repeat every 2 weeks
endostatin Endostar
7.5mg/m2,iv gtt daily up to 7 days,beginning 1 week before radiotherapy,and repeat every 2 weeks

Primary Outcomes

Measure
Response Rate (RR)
time frame: 4 weeks after CCRT

Eligibility Criteria

Male or female participants from 18 years up to 75 years old.

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

Additional Information

Official title 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
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.
Trial information was received from ClinicalTrials.gov and was last updated in September 2012.
Information provided to ClinicalTrials.gov by Sun Yat-sen University.