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

Alternate Title

Phase III Randomized Study of Gemcitabine Hydrochloride and Sorafenib Tosylate in Patients With Locally Advanced or Metastatic Adenocarcinoma of the Pancreas

Basic Trial Information

Phase	Type	Status	Age	Sponsor	Protocol IDs
Phase III	Treatment	Active	18 and over	Other	IPC-BAYPAN BAYPAN, INCA-RECF0426, IPC-2005-006, NCT00541021

Trial Description

Purpose:

Drugs used in chemotherapy such as gemcitabine, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Sorafenib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth and by blocking blood flow to the tumor. It is not yet known whether giving gemcitabine together with sorafenib is more effective than giving gemcitabine alone in treating pancreatic cancer.

This randomized phase III trial is studying giving gemcitabine together with sorafenib to see how well it works compared with giving gemcitabine alone in treating patients with locally advanced or metastatic pancreatic cancer.

Eligibility:

Eligibility criteria include the following:

• At least 18 years old
• Measurable disease
• No brain metastases
• At least 6 months since chemotherapy
• At least 4 weeks since radiation therapy or surgery
• No previous bevacizumab
• No previous organ transplant or donor cell transplant
• 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 (have an equal chance of being placed) to one of two treatment groups.

Patients in group one will receive sorafenib by mouth twice a day and an infusion of gemcitabine once a week. Treatment may continue for 7 weeks followed by 1 week of rest during course one. In the next two courses, patients will receive sorafenib twice a day and gemcitabine once a week for 3 weeks followed by 1 week of rest.

Patients in group two will receive a placebo by mouth twice a day and an infusion of gemcitabine once a week. Treatment may continue for 7 weeks followed by 1 week of rest during course one. In the next two courses, patients will receive a placebo twice a day and gemcitabine once a week for 3 weeks followed by 1 week of rest.

After finishing three courses of treatment, patients in both groups may continue to receive sorafenib or a placebo for as long as benefit is shown.

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

Marseille Institute of Cancer - Institut J. Paoli and I. Calmettes

Frederic Viret, MD, Study coordinator		Ph: 33-4-91-22-35-37 Email: viretf@marseille.fnclcc.fr

France
	Marseille
	Marseille Institute of Cancer - Institut J. Paoli and I. Calmettes
		Frederic Viret, MD	Ph:  33-4-91-22-35-37
			Email: viretf@marseille.fnclcc.fr

Registry Information
Official Title		Phase III randomized, double-blind study comparing gemcitabine and sorafenib or a placebo in patients with locally advanced or metastatic cancer of the pancreas.
Trial Start Date		2006-12-12
Registered in ClinicalTrials.gov		NCT00541021
Date Submitted to PDQ		2007-08-20
Information Last Verified		2008-12-28