Pemetrexed Plus Gemcitabine as Front-Line Chemotherapy for Patients With Malignant Pleural or Peritoneal Mesothelioma

Sponsor

Eli Lilly and Company (Industry)

Overall Status

Completed

CT.gov ID

NCT00061477

Collaborator

(none)

Enrollment

Locations

Duration (Months)

4.8

Patients Per Site

0.1

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The purposes of this study are to determine:

The safety of Pemetrexed plus Gemcitabine and any side effects that might be associated with the combination of these two drugs.
Whether Pemetrexed plus Gemcitabine can help patients with mesothelioma live longer.
Whether Pemetrexed plus Gemcitabine can make the tumor smaller or disappear, and for how long.
To see if patients feel better while taking Pemetrexed plus Gemcitabine.

Condition or Disease	Intervention/Treatment	Phase
Mesothelioma	Drug: Pemetrexed Drug: Gemcitabine	Phase 2

Study Design

Study Type:

Interventional

Allocation:

Non-Randomized

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

ALIMTA Plus Gemcitabine as Front-Line Chemotherapy for Patients With Malignant Pleural or Peritoneal Mesothelioma: A Phase II Clinical Trial

Study Start Date :

Dec 1, 2002

Study Completion Date :

Sep 1, 2006

Outcome Measures

Primary Outcome Measures

To determine the objective tumor response rate for pemetrexed plus gemcitabine every 21 days in patients with malignant pleural mesothelioma who have not received prior chemotherapy []

Secondary Outcome Measures

To assess time to objective tumor response for responding patients;To assess duration of response for responding patients;To assess time to treatment failure;To assess time to progressive disease []
To assess progression-free survival;To assess overall survival;To determine toxicities of pemetrexed in combination with gemcitabine in this population []

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Diagnosis of mesothelioma that can be treated with chemotherapy
Have received no prior chemotherapy for mesothelioma
Have at least one measurable lesion
Have an adequate performance status
Sign an informed consent

Exclusion Criteria:

Previous treatment with chemotherapy for mesothelioma
Treatment with an investigational drug within the last 30 days, previously completed or withdrawn from this study or any other study investigating Pemetrexed
Treatment with radiation therapy within the last 4 weeks
Brain metastasis that is uncontrolled
Active infection or other serious condition

Contacts and Locations

Locations

	Site	City	State	Country
1	For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559 or 317-615-4559) Mon-Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.	Aurora	Colorado	United States
2	For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559 or 317-615-4559) Mon-Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.	Tampa	Florida	United States
3	For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559 or 317-615-4559) Mon-Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.	Chicago	Illinois	United States
4	For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559 or 317-615-4559) Mon-Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.	Boston	Massachusetts	United States
5	For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559 or 317-615-4559) Mon-Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.	Detroit	Michigan	United States
6	For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559 or 317-615-4559) Mon-Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.	Albuquerque	New Mexico	United States
7	For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559 or 317-615-4559) Mon-Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.	New York	New York	United States
8	For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559 or 317-615-4559) Mon-Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.	Cleveland	Ohio	United States
9	For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559 or 317-615-4559) Mon-Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.	Philadelphia	Pennsylvania	United States
10	For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559 or 317-615-4559) Mon-Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.	Pittsburgh	Pennsylvania	United States

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