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
Overview
- Phase
- Phase 2
- Intervention
- Endostatin
- Conditions
- Non-small Cell Lung Cancer
- Sponsor
- Sun Yat-sen University
- Enrollment
- 50
- Locations
- 1
- Primary Endpoint
- Response Rate (RR)
- Last Updated
- 13 years ago
Overview
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.
Investigators
Ming Chen
Professor
Sun Yat-sen University
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)
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
Arms & Interventions
Endostatin combine CCRT
7.5mg/m2,iv gtt daily up to 7 days,beginning 1 week before radiotherapy,and repeat every 2 weeks
Intervention: Endostatin
Outcomes
Primary Outcomes
Response Rate (RR)
Time Frame: 4 weeks after CCRT
Tumor response was evaluated with thoracic CT scans when CCRT was completed, in accordance with Response Evaluation Criteria in Solid Tumors Group (RECIST).