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

The recruitment status of this study is unknown because the information has not been verified recently.

Verified September 2010 by Fudan University.
Recruitment status was Recruiting

Sponsor:

Information provided by:

Fudan University

ClinicalTrials.gov Identifier:

NCT01192243

First received: August 4, 2010

Last updated: September 2, 2010

Last verified: September 2010

History of Changes

Tracking Information

First Received Date ^ICMJE

August 4, 2010

Last Updated Date

September 2, 2010

Start Date ^ICMJE

December 2009

Estimated Primary Completion Date

December 2011 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

response rate [ Time Frame: six weeks ] [ Designated as safety issue: Yes ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT01192243 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Number of Participants with Adverse Events [ Time Frame: six weeks ] [ Designated as safety issue: Yes ]
according to NCI CTC V3.0
Progression free survival [ Time Frame: six weeks ] [ Designated as safety issue: No ]
quality of life [ Time Frame: six weeks ] [ Designated as safety issue: Yes ]
according to FACT-LCS scores

Original Secondary Outcome Measures ^ICMJE

adverse event [ Time Frame: six weeks ] [ Designated as safety issue: Yes ]
according to NCI CTC V3.0
Progression free survival [ Time Frame: six weeks ] [ Designated as safety issue: No ]
according to NCI CTC V3.0
quality of life [ Time Frame: six weeks ] [ Designated as safety issue: Yes ]
according to FACT-LCS scores

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

Brief Summary

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).

Detailed Description

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Phase 2

Study Design ^ICMJE

Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment

Condition ^ICMJE

Toxicity
Non-small Cell Lung Cancer

Intervention ^ICMJE

Drug: Gefitinib
250mg qd po d3-16
Drug: Pemetrexed
500mg/m2 venous infusion,D1,q3w
Drug: Cisplatin or carboplatin
Cisplatin:75mg/m2, venous infusion,D1,q3w or Carboplatin: AUC 5, venous infusion, D1,q3w

Study Arm (s)

Not Provided

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Recruiting

Estimated Enrollment ^ICMJE

Completion Date

Not Provided

Estimated Primary Completion Date

December 2011 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

18 Years to 70 Years (Adult, Senior)

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact: Jianhua chang, MD,PHD

13916619284

changjianhua@hotmail.com

Listed Location Countries ^ICMJE

China

Removed Location Countries

Administrative Information

NCT Number ^ICMJE

NCT01192243

Other Study ID Numbers ^ICMJE

Iressa combined with Pem/Cis

Has Data Monitoring Committee

Yes

Plan to Share Data

Not Provided

IPD Description

Not Provided

Responsible Party

Base for drug clinical trials, Fudan University Cancer Hospital, Department of Medical Oncology,Fudan University Cancer Hospital

Study Sponsor ^ICMJE

Fudan University

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Principal Investigator:

Jianhua Chang, MD,PhD

Fudan University affiliated cancer hospital

Information Provided By

Fudan University

Verification Date

September 2010

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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