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

Protgen

Status and phase: Unknown; Phase 2

Conditions: Non Small Cell Lung Cancer

Treatments: Drug: pegylated endostatin and Paclitaxel-Carboplatin; Drug: Placebo and Paclitaxel-Carboplatin

Study type: Interventional

Funder types: Industry

Identifiers

NCT01527864

M2ES2011-1

Details and patient eligibility

About

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.

Full 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.

Enrollment: 300 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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300 participants in 2 patient groups, including a placebo group

pegylated endostatin

Experimental group

Treatment:

Drug: pegylated endostatin and Paclitaxel-Carboplatin

Control

Placebo Comparator group

Treatment:

Drug: Placebo and Paclitaxel-Carboplatin