Study of Pemetrexed Plus Cisplatin in Patients With Malignant Pleural Mesothelioma

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Primary Purpose

Status

Completed

Phase

Phase 1

Locations

Japan

Study Type

Interventional

Intervention

Pemetrexed

Cisplatin

About this trial

This is an interventional treatment trial for Malignant Pleural Mesotherioma

Eligibility Criteria

20 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Duration of response

Progression free survival

Median survival time

1 year survival rate

Pulmonary function

QOL

Safety

Plasma concentration

Full Information

NCT ID

NCT00251550

First Posted

November 8, 2005

Last Updated

November 5, 2007

Sponsor

Eli Lilly and Company

1. Study Identification

Unique Protocol Identification Number

NCT00251550

Brief Title

Study of Pemetrexed Plus Cisplatin in Patients With Malignant Pleural Mesothelioma

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

November 2007

Overall Recruitment Status

Completed

Study Start Date

October 2005 (undefined)

Primary Completion Date

undefined (undefined)

Study Completion Date

August 2006 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor

Eli Lilly and Company

4. Oversight

5. Study Description

Brief Summary

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Malignant Pleural Mesotherioma

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1, Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

12 (false)

8. Arms, Groups, and Interventions

Intervention Type

Drug

Intervention Name(s)

Pemetrexed

Intervention Type

Drug

Intervention Name(s)

Cisplatin

Primary Outcome Measure Information:

Title

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

Secondary Outcome Measure Information:

Title

Duration of response

Title

Progression free survival

Title

Median survival time

Title

1 year survival rate

Title

Pulmonary function

Title

QOL

Title

Safety

Title

Plasma concentration

10. Eligibility

Sex

All

Minimum Age & Unit of Time

20 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

No

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

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)

Organizational Affiliation

Eli Lilly and Company

Official's Role

Study Director

Facility Information:

Facility Name