Related Links Educational Materials About Clinical Trials Clinical Trials Questions to Ask Your Doctor Drug Information from MedlinePlus

Alternate Title
Basic Trial Information
Trial Description
     Purpose
     Eligibility
     Treatment/Intervention
Trial Contact Information
Registry Information

Alternate Title

Phase III Randomized Study of Gemcitabine With or Without Oxaliplatin in Patients With Locally Advanced or Metastatic Unresectable Pancreatic Adenocarcinoma

Basic Trial Information

Phase	Type	Status	Age	Sponsor	Protocol IDs
Phase III	Treatment	Closed	18 to 75	Other	FRE-GERCOR-GEM-GEMOX/D00-3 EU-20324, NCT00075452

Trial Description

Purpose:

Drugs used in chemotherapy, such as gemcitabine and oxaliplatin, work in different ways to stop tumor cells from dividing so they stop growing or die. It is not yet known whether gemcitabine is more effective with or without oxaliplatin in treating pancreatic adenocarcinoma.

This randomized phase III trial is studying gemcitabine and oxaliplatin to see how well they work compared to gemcitabine alone in treating patients with locally advanced or metastatic unresectable pancreatic adenocarcinoma.

Eligibility:

Eligibility criteria include the following:

• 18-75 years old
• Measurable disease
• No brain metastases
• No previous chemotherapy or radiation therapy
• For more information about the eligibility criteria for this trial, refer to the Health Professional version.

Final eligibility for a clinical trial is determined by the health professionals conducting the trial.

Treatment/Intervention:

Patients will be randomly assigned to one of two groups.

Patients in group one will receive an infusion of gemcitabine once a week in weeks 1-7 and 9-11.

Patients in group two will receive a 1.5-hour infusion of gemcitabine on day 1 and a 2-hour infusion of oxaliplatin on day 2. Treatment may be repeated every 2 weeks for up to 3 months. After completing chemotherapy, some patients may receive chemoradiotherapy.

Quality of life will be assessed every 2 months.

Important:

For more details about this trial, refer to the Health Professional version of the trial summary.

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

GERCOR Groupe Cooperateur Multidisciplinaire en Oncologie

Christophe Louvet, MD, PhD, Study coordinator		Ph: 33-1-49-282-343 Email: christophe.louvet@sat.aphp.fr

Registry Information
Official Title		Phase III Randomized Study Of Gemcitabine Versus Gemcitabine-Oxaliplatine In Patients With Locally Advanced Or Metastatic Pancreatic Carcinoma
Trial Start Date		2003-11-18
Registered in ClinicalTrials.gov		NCT00075452
Date Submitted to PDQ		2003-11-17
Information Last Verified		2007-05-17

Back to Top