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

Primary Purpose

Non Small Cell Lung Cancer

Status

Unknown status

Phase

Phase 2

Locations

China

Study Type

Interventional

Intervention

pegylated endostatin and Paclitaxel-Carboplatin

Placebo and Paclitaxel-Carboplatin

About this trial

This is an interventional treatment trial for Non Small Cell Lung Cancer focused on measuring NSCLC

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Cancer hospital, Chinese academy of medical scienceRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

pegylated endostatin

Control

Arm Description

Outcomes

Primary Outcome Measures

Progression free survival

Secondary Outcome Measures

Full Information

NCT ID

NCT01527864

First Posted

February 2, 2012

Last Updated

February 6, 2012

Sponsor

Protgen Ltd

1. Study Identification

Unique Protocol Identification Number

NCT01527864

Brief Title

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

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

Study Type

Interventional

2. Study Status

Record Verification Date

February 2012

Overall Recruitment Status

Unknown status

Study Start Date

May 2011 (undefined)

Primary Completion Date

December 2012 (Anticipated)

Study Completion Date

April 2013 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Protgen Ltd

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Non Small Cell Lung Cancer

Keywords

NSCLC

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

300 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

pegylated endostatin

Arm Type

Experimental

Arm Title

Control

Arm Type

Placebo Comparator

Intervention Type

Drug

Intervention Name(s)

pegylated endostatin and Paclitaxel-Carboplatin

Other Intervention Name(s)

M2ES

Intervention Description

Dosage：10mg/m2

Intervention Type

Drug

Intervention Name(s)

Placebo and Paclitaxel-Carboplatin

Other Intervention Name(s)

placebo

Intervention Description

Dosage：10mg/m2

Primary Outcome Measure Information:

Title

Progression free survival

Time Frame

6 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Yan Sun, MD

Phone

8610-87788495

cancergcp@163.com

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Yan Sun, MD

Organizational Affiliation

cancer hospital, Chinese academy of medical science

Official's Role

Principal Investigator

Facility Information:

Facility Name

Cancer hospital, Chinese academy of medical science

City

Beijing

State/Province

Beijing

ZIP/Postal Code

100021

Country

China

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Yan Sun, MD

Phone

8610-87788495

cancergcp@163.com

12. IPD Sharing Statement

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

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