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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified February 2012 by Protgen Ltd.
Recruitment status was:  Recruiting
ClinicalTrials.gov Identifier:
First Posted: February 7, 2012
Last Update Posted: February 7, 2012
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Protgen Ltd
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.

Condition Intervention Phase
Non Small Cell Lung Cancer Drug: pegylated endostatin and Paclitaxel-Carboplatin Drug: Placebo and Paclitaxel-Carboplatin Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:

Further study details as provided by Protgen Ltd:

Primary Outcome Measures:
  • Progression free survival [ Time Frame: 6 weeks ]

Estimated Enrollment: 300
Study Start Date: May 2011
Estimated Study Completion Date: April 2013
Estimated Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: pegylated endostatin Drug: pegylated endostatin and Paclitaxel-Carboplatin
Other Name: M2ES
Placebo Comparator: Control Drug: Placebo and Paclitaxel-Carboplatin
Other Name: placebo

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.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01527864

Contact: Yan Sun, MD 8610-87788495 cancergcp@163.com

China, Beijing
Cancer hospital, Chinese academy of medical science Recruiting
Beijing, Beijing, China, 100021
Contact: Yan Sun, MD    8610-87788495    cancergcp@163.com   
Sponsors and Collaborators
Protgen Ltd
Principal Investigator: Yan Sun, MD cancer hospital, Chinese academy of medical science
  More Information

Responsible Party: Protgen Ltd
ClinicalTrials.gov Identifier: NCT01527864     History of Changes
Other Study ID Numbers: M2ES2011-1
First Submitted: February 2, 2012
First Posted: February 7, 2012
Last Update Posted: February 7, 2012
Last Verified: February 2012

Keywords provided by Protgen Ltd:

Additional relevant MeSH terms:
Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms
Albumin-Bound Paclitaxel
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Growth Inhibitors