Study of Pemetrexed Plus Cisplatin in Patients With Malignant Pleural Mesothelioma

This study has been completed.

Sponsor:

Information provided by:

Eli Lilly and Company

ClinicalTrials.gov Identifier:

NCT00251550

First received: November 8, 2005

Last updated: November 5, 2007

Last verified: November 2007

History of Changes

Tracking Information

First Received Date ^ICMJE

November 8, 2005

Last Updated Date

November 5, 2007

Start Date ^ICMJE

October 2005

Primary Completion Date

Not Provided

Current Primary Outcome Measures ^ICMJE

To determine the recommended dose of LY231514 and cisplatin combination therapy, Response Rate

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00251550 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Duration of response
Progression free survival
Median survival time
1 year survival rate
Pulmonary function
QOL
Safety
Plasma concentration

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Study of Pemetrexed Plus Cisplatin in Patients With Malignant Pleural Mesothelioma

Official Title ^ICMJE

Phase I/II Study of LY231514 Plus Cisplatin in Patients With Malignant Pleural Mesothelioma

Brief Summary

To investigate efficacy and safety of pemetrexed combined with cisplatin for chemo-naive patients with Malignant Pleural Mesothelioma.

Detailed Description

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Phase 1
Phase 2

Study Design ^ICMJE

Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment

Condition ^ICMJE

Malignant Pleural Mesotherioma

Intervention ^ICMJE

Drug: Pemetrexed
Drug: Cisplatin

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

Completed

Enrollment ^ICMJE

Completion Date

August 2006

Primary Completion Date

Not Provided

Eligibility Criteria ^ICMJE

Inclusion Criteria:

Inapplicable for radical operation
Not received prior systemic chemotherapy
Performance status: 0-1

Exclusion Criteria:

Having a history of sensitivity to platinum agent, folic acid or vitamin B12

Gender

Both

Ages

20 Years to 75 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Japan

Administrative Information

NCT Number ^ICMJE

NCT00251550

Other Study ID Numbers ^ICMJE

5249, H3E-JE-ME01

Has Data Monitoring Committee

Not Provided

Responsible Party

Not Provided

Study Sponsor ^ICMJE

Eli Lilly and Company

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Study Director:

Call 1-877-CTLILLY(1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time(UTC/GMT - 5 hours, EST)

Eli Lilly and Company

Information Provided By

Eli Lilly and Company

Verification Date

November 2007

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

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