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


Phase 2
18 Years
N/A
Not Enrolling
Both
Mesothelioma

Thank you

Trial Information

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


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or withdrawn from this study or any other study investigating Pemetrexed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

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

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

Principal Investigator

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)

Investigator Role:

Study Director

Investigator Affiliation:

Eli Lilly and Company

Authority:

United States: Food and Drug Administration

Study ID:

7214

NCT ID:

NCT00061477

Start Date:

December 2002

Completion Date:

September 2006

Related Keywords:

  • Mesothelioma
  • Mesothelioma

Name

Location

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  
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  
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  
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  
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  
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  
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  
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  
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