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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***
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