Know Cancer

or
forgot password

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


Phase 2
18 Years
N/A
Open (Enrolling)
Both
Non Small Cell Lung Cancer

Thank you

Trial Information

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 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.


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.

Type of Study:

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

Outcome Measure:

Progression free survival

Outcome Time Frame:

6 weeks

Safety Issue:

No

Principal Investigator

Yan Sun, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

cancer hospital, Chinese academy of medical science

Authority:

China: Food and Drug Administration

Study ID:

M2ES2011-1

NCT ID:

NCT01527864

Start Date:

May 2011

Completion Date:

April 2013

Related Keywords:

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

Name

Location