Study of Pemetrexed Plus Cisplatin in Patients With Malignant Pleural Mesothelioma
Sponsor
Eli Lilly and Company (Industry)
Overall Status
Completed
CT.gov ID
NCT00251550
Collaborator
(none)
12
7
10
1.7
0.2
Study Details
Study Description
Brief Summary
To investigate efficacy and safety of pemetrexed combined with cisplatin for chemo-naive patients with Malignant Pleural Mesothelioma.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
| Phase 1/Phase 2 |
Study Design
Study Type:
Interventional
Allocation:
Non-Randomized
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Phase I/II Study of LY231514 Plus Cisplatin in Patients With Malignant Pleural Mesothelioma
Study Start Date
:
Oct 1, 2005
Actual Study Completion Date
:
Aug 1, 2006
Outcome Measures
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 []
Eligibility Criteria
Criteria
Ages Eligible for Study:
20 Years
to 75 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | 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 | Aichi | Japan | ||
| 2 | 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 | Ehime | Japan | ||
| 3 | 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 | Fukuoka | Japan | ||
| 4 | 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 | Hokkaido | Japan | ||
| 5 | 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 | Okayama | Japan | ||
| 6 | 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 | Osaka | Japan | ||
| 7 | 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 | Tokyo | Japan |
Sponsors and Collaborators
- Eli Lilly and Company
Investigators
- 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
Study Documents (Full-Text)
None provided.More Information
Additional Information:
Publications
None provided.Responsible Party:
,
,
ClinicalTrials.gov Identifier:
NCT00251550
Other Study ID Numbers:
- 5249
- H3E-JE-ME01
First Posted:
Nov 10, 2005
Last Update Posted:
Nov 6, 2007
Last Verified:
Nov 1, 2007