Study of Gefitinib Compared With Pemetrexed/Cisplatin in Advanced Non-Small Cell Lung Cancer Patients

September 2, 2010 updated by: Fudan University

Phase 2 Study of Gefitinib Compared With Pemetrexed/Cisplatin in Advanced Non-Small

The purpose of this study is to examine the efficacy and safety of gefitinib combinated with Pemetrexed/Cisplatin in advanced non-small cell lung cancer (NSCLC).

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

Phase

Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

China
- Shanghai
  - Shanghai, Shanghai, China, 200032
    - Recruiting
    - Cancer hospital Fudan University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

Genders Eligible for Study

All

Description

Inclusion Criteria:

Patients who were diagnosed by the histologic, cytologic diagnosis of IV non-small cell lung cancer
Age from 18 to 70 years old
At least one target lesion diameter spiral CT ≥ 1 cm, or the common CT ≥ 2 cm, and can be measured by imaging tools
ECOG 0-1
Expected life time longer than 12 weeks
Normal laboratory values:

leucocyte≥ 4×109/L neutrophil≥ 1.5×109/L platelet≥100×109/L Hemoglobin≥ 10g/L ALT and AST ≤2.5×ULN (≤5×ULN if liver metastasis)

Exclusion Criteria:

Patients have not used drugs according to protocol
Patients were allergic to pemetrexed or cisplatin
Patients received radiotherapy or other biological treatment 4 weeks before the trial
Uncontrolled hydrothorax or hydropericardium
neuropathy toxicity ≥ CTC 3
Severe symptomatic heart disease
Active upper gastrointestinal ulcer or digestive disfunction
Severe infection or metabolic disfunction
Patients with other malignant tumor
Uncontrolled brain metastases
Patients have accepted other clinical trials
Female patients during their pregnant and lactation period, or patients without contraception

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Interventional Model: Parallel Assignment
Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
response rate Time Frame: six weeks	six weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants with Adverse Events Time Frame: six weeks	according to NCI CTC V3.0	six weeks
Progression free survival Time Frame: six weeks		six weeks
quality of life Time Frame: six weeks	according to FACT-LCS scores	six weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Fudan University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2009

Primary Completion (Anticipated)

December 1, 2011

Study Registration Dates

First Submitted

August 4, 2010

First Submitted That Met QC Criteria

August 31, 2010

First Posted (Estimate)

September 1, 2010

Study Record Updates

Last Update Posted (Estimate)

September 3, 2010

Last Update Submitted That Met QC Criteria

September 2, 2010

Last Verified