Recombinant Human Endostatin Continued Pumping Into Vein Combining With CCRT in Unresectable Stage III NSCLC

University of Chinese Academy Sciences

Status and phase: Completed; Phase 2; Phase 1

Conditions: Stage III Non-small-Cell Lung Cancer

Treatments: Drug: cisplatinum (50mg/m2) IV (in the vein) on day 1 and day 8 of a 28-day cycle for 2 cycles; Drug: Etoposide (50mg/m2) IV (in the vein) on day 1 to day 5 of a 28-day cycle for 2 cycles; Drug: Recombinant human endostatin; Other: laboratory biomarker analysis; Other: CT perfusion imaging

Study type: Interventional

Funder types: Other

Identifiers

NCT01733589

[2012]-10-24

Details and patient eligibility

About

Resistance of hypoxic tumor cells to radiation is a significant reason of failure in the local control of tumors, especially the squamous cell carcinomas. Preclinical models have shown that Endostar may transiently "normalize" the tumor vasculature to make it more efficient for oxygen delivery, thereby providing a window of opportunity for enhanced sensitivity to radiation treatment. This study is to evaluate the safety, toxicity, and efficacy of the addition of Endostar Continued Pumping into Vein to the standard CCRT regimen in patients with unresectable stage III NSCLC.

Full description

Primary

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).

Secondary

Measure changes in VEGF and other angiogenic cytokines and antiangiogenic factors in plasma samples from these patients.

Evaluate the application of CT perfusion imaging to determine changes in tumor vascular mophology and function during treatment.

Enrollment: 73 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• untreated histologic or cytologic of NSCLC verified
• inoperable stage IIIA or IIIB NSCLC
• measurable disease by RECIST
• 18~70 years of age
• an ECOG PS of 0 to 1
• absolute neutrophil count (ANC) of ≥1500/μL, hemoglobin ≥10gm/dL, platelet ≥100,000/μL
• serum creatinine ≤1.25 times of upper limit of normal (ULN), calculated creatinine clearance (CrCl) of ≥60ml/min
• bilirubin 1.5×ULN, AST and ALT less than 2.5×ULN, alkaline phosphatase less than 5×ULN
• forced vital capacity in 1 second (FEV1) higher than 0.8 L
• CB6 is normal
• Written informed consent

Exclusion criteria

• a history of other malignant diseases
• any contraindications for chemoradiotherapy
• distant metastasis
• malignant pleural and/or pericardial effusion
• pregnant or nursing
• preexisting bleeding diatheses or coagulopathy

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

73 participants in 1 patient group

Recombinant Human Endostatin

Experimental group

Description:

All patients received recombinant human endostatin(7.5mg/m2/24h) Continued Pumping Into Vein through 5 days at week 1, 3, 5, and 7. During week 2 through 8, patients received etoposide 50mg/m2 days 1-5 and cisplatin 50mg/m2 on day 1,8, every 4 weeks for two cycles with concurrent thoracic radiation at 60\~66Gy in 30\~33 fractions for 6\~7 weeks.

Treatment:

Other: CT perfusion imaging

Other: laboratory biomarker analysis

Drug: Recombinant human endostatin

Drug: cisplatinum (50mg/m2) IV (in the vein) on day 1 and day 8 of a 28-day cycle for 2 cycles

Drug: Etoposide (50mg/m2) IV (in the vein) on day 1 to day 5 of a 28-day cycle for 2 cycles