Trial | NCT00708812  Report issue

Title

Paclitaxel Plus Carboplatin With or Without Endostar in Patients With Advanced Non-small Cell Lung Cancer
Paclitaxel Plus Carboplatin (TC) Versus TC Plus Endostar in Patients With Advanced Non-small Cell Lung Cancer(NSCLC): a Randomized, Double-blind, Placebo-controlled, Multicentre Study

  • Phase

    Phase 2

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Study Participants

    126
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.
Study Started
Jul 31
2007
Primary Completion
Sep 30
2009
Study Completion
Dec 31
2009
Last Update
Jul 21
2011
Estimate

Drug Endostar(Recombinant Human Endostatin Injection)

Endostar 7.5mg/m2 on d8-d21 in each 21-day cycle

Drug paclitaxel-carboplatin

paclitaxel, 175mg/m2, iv, d1, q3w; carboplatin, AUC 5, iv, d1, q3w

The control group Active Comparator

paclitaxel-carboplatin

The treatment group Experimental

paclitaxel-carboplatin plus Endostar

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
No Results Posted