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Trial Title:
Paclitaxel-Carboplatin Alone or With M2ES for Non-Small-Cell Lung Cancer
NCT ID:
NCT01527864
Condition:
Non Small Cell Lung Cancer
Conditions: Official terms:
Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Paclitaxel
Albumin-Bound Paclitaxel
Carboplatin
Endostatins
Conditions: Keywords:
NSCLC
Study type:
Interventional
Study phase:
Phase 2
Overall status:
Unknown status
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Treatment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Intervention:
Intervention type:
Drug
Intervention name:
pegylated endostatin and Paclitaxel-Carboplatin
Description:
Dosage：10mg/m2
Arm group label:
pegylated endostatin
Other name:
M2ES
Intervention type:
Drug
Intervention name:
Placebo and Paclitaxel-Carboplatin
Description:
Dosage：10mg/m2
Arm group label:
Control
Other name:
placebo
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.
Criteria for eligibility:
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.
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Cancer hospital, Chinese academy of medical science
Address:
City:
Beijing
Zip:
100021
Country:
China
Status:
Recruiting
Contact:
Last name:
Yan Sun, MD
Phone:
8610-87788495
Email:
cancergcp@163.com
Start date:
May 2011
Completion date:
April 2013
Lead sponsor:
Agency:
Protgen Ltd
Agency class:
Industry
Source:
Protgen Ltd
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT01527864
