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

Alternate Title

Prospective Cohort Study of Gemcitabine Versus Intensive Pancreatic Proteolytic Enzyme Therapy With Ancillary Nutritional Support (Gonzalez Regimen) in Patients With Stage II, III, or IV Adenocarcinoma of the Pancreas

Basic Trial Information

Phase	Type	Status	Age	Sponsor	Protocol IDs
No phase specified	Treatment	Closed	18 to physiologic 65	NCCAM, Other	CPMC-IRB-8544 NCCAM, NCI-V99-1538, NCT00003851

Trial Description

Purpose:

Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Pancreatic enzymes may help kill cancer cells. It is not yet known if gemcitabine is more effective than pancreatic enzyme therapy plus specialized diet for pancreatic cancer.

This clinical trial is comparing the effectiveness of gemcitabine with that of pancreatic enzyme therapy plus specialized diet (Gonzalez regimen) in treating patients who have stage II, stage III, or stage IV pancreatic cancer.

Eligibility:

Eligibility criteria include the following:

• 18-65 years old
• No more than 8 weeks since diagnosis
• 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 treated in one of two groups. Patients in group one will receive pancreatic enzymes and nutritional supplements by mouth every 4 hours and at meals for 16 days followed by 5 days of rest. They will also consume a vegetarian diet. Treatment may be repeated every 3 weeks for as long as benefit is shown. Patients in group two will receive gemcitabine-based chemotherapy. Quality of life will be assessed periodically. Patients will be evaluated at 1, 3, and 7 months, 1 year, and once a year thereafter.

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

Herbert Irving Comprehensive Cancer Center at Columbia University Medical Center

John Chabot, MD, Protocol chair		Ph: 212-305-9468

Registry Information
Official Title		Evaluation of Intensive Pancreatic Proteolytic Enzyme Therapy with Ancillary Nutritional Support Versus Gemcitabine Chemotherapy in the Treatment of Inoperable Pancreatic Adenocarcinoma
Trial Start Date		1999-03-25
Registered in ClinicalTrials.gov		NCT00003851
Date Submitted to PDQ		1999-04-06
Information Last Verified		2005-12-05
NCI Grant/Contract Number		P30-CA13696

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