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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified February 2012 by Protgen Ltd.
Recruitment status was  Recruiting
Sponsor:
Information provided by (Responsible Party):
Protgen Ltd
ClinicalTrials.gov Identifier:
NCT01527864
First received: February 2, 2012
Last updated: February 6, 2012
Last verified: February 2012
  Purpose

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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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 ] [ Designated as safety issue: No ]

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
Dosage:10mg/m2
Other Name: M2ES
Placebo Comparator: Control Drug: Placebo and Paclitaxel-Carboplatin
Dosage:10mg/m2
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01527864

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

Locations
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
Investigators
Principal Investigator: Yan Sun, MD cancer hospital, Chinese academy of medical science
  More Information

No publications provided

Responsible Party: Protgen Ltd
ClinicalTrials.gov Identifier: NCT01527864     History of Changes
Other Study ID Numbers: M2ES2011-1
Study First Received: February 2, 2012
Last Updated: February 6, 2012
Health Authority: China: Food and Drug Administration

Keywords provided by Protgen Ltd:
NSCLC

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

ClinicalTrials.gov processed this record on October 19, 2014