Paclitaxel-Carboplatin Alone or With M2ES for Non-Small-Cell Lung Cancer

February 6, 2012 updated by: Protgen Ltd

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

300

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Beijing
      • Beijing, Beijing, China, 100021
        • Recruiting
        • Cancer Hospital, Chinese Academy of Medical Science
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. 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.
  2. Prior radiation therapy was allowed provided that the only sites disease were not located in lung.
  3. Measurable disease as defined by the Response Evaluation Criteria in Solid Tumors (RECIST).
  4. ≥18 years of age.
  5. ECOG performance status of 0 or 1.
  6. Life expectancy of at least 12 weeks.
  7. Adequate hematologic, hepatic, and renal function.
  8. Patients are voluntary to participate and sigh the informed contents.

Exclusion Criteria:

  1. Major surgery within the prior 4 weeks.
  2. Participating any clinical trial within the prior 4 weeks.
  3. Patients had clinically apparent CNS disease ( primary brain tumors, tumor related apoplexy, CNS metastases, carcinomatous meningitis.)
  4. 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.
  5. Pregnant or lactating women.
  6. Radiation therapy have not been completed 4 weeks before enrollment.
  7. Pulmonary embolus, deep venous thrombosis or bleeding diathesis.
  8. 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.
  9. Grade 2 hemoptysis within the past 6 months.
  10. Acute or chronic renal disease.
  11. Active hepatitis or HIV.
  12. ECG: QTC ≥ 480 ms.
  13. Patients on therapeutic doses of heparin.
  14. Other conditions that are regarded for exclusion by the investigator.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Control
Drug: Placebo and Paclitaxel-Carboplatin
Dosage：10mg/m2
Other Names:
  • placebo
Experimental: pegylated endostatin
Drug: pegylated endostatin and Paclitaxel-Carboplatin
Dosage：10mg/m2
Other Names:
  • M2ES

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Progression free survival
Time Frame: 6 weeks
6 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Protgen Ltd

Investigators

  • Principal Investigator: Yan Sun, MD, Cancer Hospital, Chinese Academy of Medical Science

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2011

Primary Completion (Anticipated)

December 1, 2012

Study Completion (Anticipated)

April 1, 2013

Study Registration Dates

First Submitted

February 2, 2012

First Submitted That Met QC Criteria

February 6, 2012

First Posted (Estimate)

February 7, 2012

Study Record Updates

Last Update Posted (Estimate)

February 7, 2012

Last Update Submitted That Met QC Criteria

February 6, 2012

Last Verified

February 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • M2ES2011-1

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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