- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01527864
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 Contact
- Name: Yan Sun, MD
- Phone Number: 8610-87788495
- Email: cancergcp@163.com
Study Locations
-
-
Beijing
-
Beijing, Beijing, China, 100021
- Recruiting
- Cancer Hospital, Chinese Academy of Medical Science
-
Contact:
- Yan Sun, MD
- Phone Number: 8610-87788495
- Email: cancergcp@163.com
-
-
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:
- 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 1.
- 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.
- Active hepatitis or HIV.
- ECG: QTC ≥ 480 ms.
- Patients on therapeutic doses of heparin.
- 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
|
Dosage:10mg/m2
Other Names:
|
Experimental: pegylated endostatin
|
Dosage:10mg/m2
Other Names:
|
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
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
- Respiratory Tract Diseases
- Neoplasms
- Lung Diseases
- Neoplasms by Site
- Respiratory Tract Neoplasms
- Thoracic Neoplasms
- Carcinoma, Bronchogenic
- Bronchial Neoplasms
- Lung Neoplasms
- Carcinoma, Non-Small-Cell Lung
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Antineoplastic Agents
- Tubulin Modulators
- Antimitotic Agents
- Mitosis Modulators
- Antineoplastic Agents, Phytogenic
- Angiogenesis Inhibitors
- Angiogenesis Modulating Agents
- Growth Substances
- Growth Inhibitors
- Carboplatin
- Paclitaxel
- Albumin-Bound Paclitaxel
- Endostatins
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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