Articles and Resources


Pemetrexed Disodium and Either Gemcitabine or Carboplatin in Treating Patients With Advanced Malignant Pleural Mesothelioma
February 16, 2006

Alternative Title
Basic Trial Information
Trial Description
     Purpose
     Eligibility
     Treatment/Intervention
Trial Contact Information

Alternative Title

Phase II Randomized Study of Pemetrexed Disodium Combined With Either Gemcitabine or Carboplatin in Patients With Advanced Malignant Mesothelioma of the Pleura.

Basic Trial Information

Phase Type Status Age Sponsor Protocol IDs
Phase II Treatment Active 18 and over NCI ECOG-E1B03
NCT00101283,
NCCTG-E1B03

Trial Description

Purpose:

Drugs used in chemotherapy, such as pemetrexed disodium, gemcitabine, and carboplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more tumor cells. It is not yet known whether giving pemetrexed disodium with gemcitabine is more effective than giving pemetrexed disodium with carboplatin in treating malignant pleural mesothelioma.

This randomized phase II trial is studying pemetrexed disodium and gemcitabine to see how well they work compared to pemetrexed disodium and carboplatin in treating patients with advanced malignant pleural mesothelioma.

Eligibility:

Eligibility criteria include the following:

     At least 18 years old
     No brain metastases

Final eligibility for a clinical trial is determined by the health professionals conducting the trial. For more details about the eligibility requirements for this trial and the treatment or intervention, refer to the Health Professional version of the trial summary.

Treatment/Intervention:

Patients will be randomly assigned (have an equal chance of being placed in one of two treatment groups).

Patients in group one will receive an infusion of pemetrexed disodium and an infusion of carboplatin once in week 1.

Patients in group two will receive an infusion of pemetrexed disodium as in group one. They will also receive an infusion of gemcitabine once in weeks 1 and 2.

Treatment in both groups may repeat every 3 weeks for up to six courses.

Beginning approximately 5-10 days before the start chemotherapy and continuing until approximately 3 weeks after the completion of chemotherapy, all patients will receive folic acid by mouth once a day. They will also receive an injection of vitamin B12 every 9 weeks.

Patients will be evaluated every 3 months for 2 years and every 6 months for 1 year.

Important:

If you are interested in participating in a clinical trial, contact your doctor for a referral or call a trial contact person listed below. You may see the same contact person listed at more than one site, however, if you call the number listed you can ask to speak to the study coordinator or person involved with the specific trial you are interested in. If you have questions about cancer or clinical trials, call the Cancer Information Service at 1-800-4-CANCER (1-800-422-6237). General information about clinical trials, including risks, benefits, and costs, can be found on NCI's Web site.

Trial Contact Information

Trial Lead Organizations:

Eastern Cooperative Oncology Group

Nasser Hanna, MD, Protocol chair
     Ph: 317-274-3515; 888-600-4822

Corey Langer, MD, Protocol co-chair
     Ph: 215-728-2985; 888-369-2571
     Email: cj_langer@fccc.edu

North Central Cancer Treatment Group

Scott Okuno, MD, Protocol chair
     Ph: 507-284-2511
     Email: okuno.scott@mayo.edu

Trial Sites and Contacts:


U.S.A.

Delaware

    Lewes

     Beebe Medical Center
    Clinical Trials Office - Beebe Medical Center
    Ph: 302-645-3171

    Newark

    CCOP - Christiana Care Health Services
    Clinical Trial Office - CCOP - Christiana Care Health Services
    Ph: 302-733-6227

Maryland

    Elkton MD

    Union Hospital Cancer Center at Union Hospital
    Gregory Masters, MD
    Ph: 302-366-1200

New Jersey

    East Orange

    Veterans Affairs Medical Center - East Orange
    Basil Kasimis, MD, DSc
    Ph: 973-676-1000 ext 1406

    New Brunswick

    Cancer Institute of New Jersey at UMDNJ - Robert Wood Johnson Medical School
    Clinical Trials Office - Cancer Institute of New Jersey at UMDNJ
    Ph: 732-235-8675

     Red Bank

    Booker Cancer Center at Riverview Medical Center
    Denis Fitzgerald, MD
    Ph: 732-530-8666

     Voorhees

    Cancer Institute of New Jersey at the Cooper University Hospital - Voorhees
    Clinical Trials Office
    Ph: 856-325-6757

New York

    Bronx

    Albert Einstein Cancer Center at Albert Einstein College of Medicine
    Clinical Trials Office - Albert Einstein Cancer Center
    Ph: 718-430-2302
    Email: aecc@aecom.yu.edu

Pennsylvania

    Danville

    Geisinger Medical Center
    Clinical Trials Office - Geisinger Medical Center
    Ph: 570-271-5251

    State College

    Geisinger Medical Group
    Albert Bernath, MD
    Ph: 814-234-5021

    Wilkes-Barre

    Frank M. and Dorothea Henry Cancer Center at Geisinger Wyoming Valley Medical Center
    Clinical Trials Office - Frank M. and Dorothea Henry Cancer Center
    Ph: 570-271-5251

***Source: http://www.cancer.gov/clinicaltrials***