A Multicenter, Randomized, Double-Blind, Placebo-Controlled Phase II Study to Evaluate the Efficacy of Paclitaxel-Carboplatin Alone or With Pegylated Endostatin for Advanced Non-small Cell Lung Cancer

Protgen Ltd1 site in 1 country300 target enrollmentMay 2011

ConditionsNon Small Cell Lung Cancer

Interventionspegylated endostatin and Paclitaxel-Carboplatin Placebo and Paclitaxel-Carboplatin

Drugspegylated endostatin and Paclitaxel-Carboplatin Placebo and Paclitaxel-Carboplatin

Overview

Phase: Phase 2
Intervention: pegylated endostatin and Paclitaxel-Carboplatin
Conditions: Non Small Cell Lung Cancer
Sponsor: Protgen Ltd
Enrollment: 300
Locations: 1
Primary Endpoint: Progression free survival
Last Updated: 14 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

A phase II, multicenter, randomized, double-blind, placebo-controlled study was carried out. Patients were randomly assigned to the treatment (PC + pegylated endostatin) or the control group (PC+ placebo). The efficacy was evaluated every six weeks.Follow-up continued until disease progression or death.

Detailed Description

A randomized phase 2 study, involving patients with advanced non-small-cell lung cancer who had not previously received chemotherapy, compared paclitaxel and carboplatin Plus placebo with paclitaxel and carboplatin plus PEGylated endostatin, with PEGylated endostatin at a dose of 10 mg/m2 intravenously every weeks.

Registry

clinicaltrials.gov

Start Date

May 2011

End Date

April 2013

Last Updated

14 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Protgen Ltd

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Histologically or cytologically confirmed, newly diagnosed stage IIIB or stage IV cancer or recurrent non-small-cell lung cancer for which they had not received chemotherapy, targeted therapy.
•Prior radiation therapy was allowed provided that the only sites disease were not located in lung.
•Measurable disease as defined by the Response Evaluation Criteria in Solid Tumors (RECIST).
•≥18 years of age.
•ECOG performance status of 0 or
•Life expectancy of at least 12 weeks.
•Adequate hematologic, hepatic, and renal function.
•Patients are voluntary to participate and sigh the informed contents.

Exclusion Criteria

•Major surgery within the prior 4 weeks.
•Participating any clinical trial within the prior 4 weeks.
•Patients had clinically apparent CNS disease ( primary brain tumors, tumor related apoplexy, CNS metastases, carcinomatous meningitis.)
•Another active malignancy, or any history of other malignancy within the past 3 years except for nonmelanoma skin cancer and carcinoma in situ of the cervix.
•Pregnant or lactating women.
•Radiation therapy have not been completed 4 weeks before enrollment.
•Pulmonary embolus, deep venous thrombosis or bleeding diathesis.
•Uncontrolled intercurrent illness as following: prior or ongoing uncontrolled hypertension;angina pectoris; congestive cardiac failure; myocardial ischemia, infarction, uncompensated coronary artery disease within the past 12 months; Uncontrolled arrhythmia; Uncontrolled diabetes mellitus; Uncontrolled infection.
•Grade 2 hemoptysis within the past 6 months.
•Acute or chronic renal disease.