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
18 Years
75 Years
Both
Non-small Cell Lung Cancer
Trial Information
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
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.
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
Type of Study:
Interventional
Study Design:
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Response Rate (RR)
Outcome Description:
Tumor response was evaluated with thoracic CT scans when CCRT was completed, in accordance with Response Evaluation Criteria in Solid Tumors Group (RECIST).
Outcome Time Frame:
4 weeks after CCRT
Safety Issue:
Yes
Principal Investigator
Ming Chen, Doctor
Investigator Role:
Study Chair
Investigator Affiliation:
Sun Yat-sen University
Authority:
China: Food and Drug Administration
Study ID:
DP-EN-RT
NCT ID:
NCT01218594
Start Date:
May 2009
Completion Date:
December 2015
Related Keywords:
- Non-Small Cell Lung Cancer
- Stage III
- Unresectable
- Non-small cell lung cancer
- Carcinoma, Non-Small-Cell Lung
- Lung Neoplasms
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