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

NCT01527864 | Unknown Phase 2 DMC

• 1 other identifier: M2ES2011-1
• Study Type: interventional
• Target: 300
• Locations: 1 country
• Sites: 1

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.

Conditions

Non Small Cell Lung Cancer

Keywords

NSCLC

Outcome Measures

Primary Outcomes (1)

• Progression free survival

  6 weeks

Study Arms (2)

pegylated endostatin

EXPERIMENTAL

Drug: pegylated endostatin and Paclitaxel-Carboplatin

Control

PLACEBO COMPARATOR

Drug: Placebo and Paclitaxel-Carboplatin

Interventions

pegylated endostatin and Paclitaxel-Carboplatin DRUG

Dosage：10mg/m2

Also known as: M2ES

pegylated endostatin

Placebo and Paclitaxel-Carboplatin DRUG

Dosage：10mg/m2

Also known as: placebo

Control

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Protgen Ltd: lead

Study Sites (1)

Cancer hospital, Chinese academy of medical science

Beijing, Beijing Municipality, 100021, China

RECRUITING

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Interventions

CP protocol

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Yan Sun, MD

  Cancer Hospital Chinese Academy of Medical Science

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Yan Sun, MD

CONTACT

8610-87788495; cancergcp@163.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 2, 2012
• First Posted: February 7, 2012
• Study Start: May 1, 2011
• Primary Completion: December 1, 2012
• Study Completion: April 1, 2013
• Last Updated: February 7, 2012

Record last verified: 2012-02

Locations

CN (1)