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

Non Small Cell Lung Cancer Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01527864
• Other study ID #: M2ES2011-1
• Status: Recruiting
• Phase: Phase 2
• First received: February 2, 2012
• Last updated: February 6, 2012
• Start date: May 2011
• Est. completion date: April 2013

Study information

• Verified date: February 2012
• Source: Protgen Ltd
• Contact: Yan Sun, MD
• Phone: 8610-87788495
• Email: cancergcp[@]163.com
• Is FDA regulated: No
• Health authority: China: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 300
• Est. completion date: April 2013
• Est. primary completion date: December 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung
• Lung Neoplasms
• Non Small Cell Lung Cancer

Intervention

Drug:
• pegylated endostatin and Paclitaxel-Carboplatin
Dosage:10mg/m2
• Placebo and Paclitaxel-Carboplatin
Dosage:10mg/m2

Locations

Country	Name	City	State
China	Cancer hospital, Chinese academy of medical science	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Protgen Ltd

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Progression free survival		6 weeks	No