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

Simcere

Status and phase: Completed; Phase 2

Conditions: Advanced Non-small Cell Lung Cancer

Treatments: Drug: paclitaxel-carboplatin; Drug: Endostar(Recombinant Human Endostatin Injection)

Study type: Interventional

Funder types: Industry

Identifiers

NCT00708812

XYL014

Details and patient eligibility

About

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.

Enrollment: 126 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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126 participants in 2 patient groups

The control group

Active Comparator group

Description:

paclitaxel-carboplatin

Treatment:

Drug: paclitaxel-carboplatin

The treatment group

Experimental group

Description:

paclitaxel-carboplatin plus Endostar

Treatment:

Drug: paclitaxel-carboplatin

Drug: Endostar(Recombinant Human Endostatin Injection)