NCT01527864UnknownPhase 2
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
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Phase 2
- Sponsor
- Protgen Ltd
- Enrollment
- 300
- Locations
- 1
- Primary Endpoint
- Progression free survival
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
- •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.
Arms & Interventions
pegylated endostatin
Experimental
Intervention: pegylated endostatin and Paclitaxel-Carboplatin (Drug)
Control
Placebo Comparator
Intervention: Placebo and Paclitaxel-Carboplatin (Drug)
Outcomes
Primary Outcomes
Progression free survival
Time Frame: 6 weeks
Secondary Outcomes
No secondary outcomes reported
Investigators
Study Sites (1)
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