Paclitaxel Plus Carboplatin With or Without Endostar in Patients With Advanced Non-small Cell Lung Cancer

• Status: Completed
• Trial end date: 2009-12-01
• Target enrollment: 0
• Participant gender: All

Summary

In this randomized, double-blind, placebo-controlled, multicentre trial, 126 patients between July 5, 2007 and July 30, 2008 were enrolled from 10 centers. The leader units are Shanghai Chest Hospital Affiliated to Shanghai Jiao-Tong University and Shanghai Changzheng Hospital. All eligible patients received 1 cycle (21 days) of TC chemotherapy. After chemotherapy, patients evaluated as SD (Stable Disease) or above were randomized to receive endostar plus TC or TC alone for 3 cycles, 21 days as one cycle.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Shandong Simcere-Medgenn Bio-pharmaceutical Co., Ltd
• Treatments: Albumin-Bound Paclitaxel; Carboplatin; Endostar protein; Endostatins; Paclitaxel

Criteria

Inclusion Criteria:

• histologically or cytologically confirmed, previously untreated stage IIIB or IV NSCLC

• age of 18-75 years

• at least one measurable lesion (RECIST)

• patients evaluated as SD or above after 1 cycle (21 days) of TC chemotherapy .

• adequate hematologic, cardiac, renal, and hepatic function

• ECOG PS 0-2

Exclusion Criteria:

• symptomatic brain metastases

• bone metastases with complications

• major organ dysfunction

• bleeding diathesis or coagulopathy

• pregnant or lactating woman