Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outline
Trial Contact Information
Registry Information

Alternate Title

Gemcitabine Compared With Pancreatic Enzyme Therapy Plus Specialized Diet (Gonzalez Regimen) in Treating Patients Who Have Stage II, Stage III, or Stage IV Pancreatic Cancer

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

Objectives

1. Compare the survival of patients with stage II, III, or IV adenocarcinoma of the pancreas treated with gemcitabine versus intensive proteolytic enzyme therapy and adjunctive dietary and nutritional support.
2. Compare the quality of life in patients treated with these regimens.

Entry Criteria

Disease Characteristics:

• Histologically confirmed unresectable primary or metastatic adenocarcinoma of the pancreas diagnosed within the past 8 weeks
  • Stage II-IV

Prior/Concurrent Therapy:

Biologic therapy:

• Not specified

Chemotherapy:

• No prior chemotherapy
• No other concurrent chemotherapy

Endocrine therapy:

• No concurrent hormonal therapy except:
  • Steroids for antiemesis, documented CNS metastases, adrenal failure, or septic shock
  • Hormonal therapy for nondisease related conditions (e.g., thyroid replacement therapy)

Radiotherapy:

• No prior radiotherapy
• Concurrent palliative radiotherapy allowed, including to a symptomatic lesion or one which may produce disability (e.g., unstable femur or CNS lesion)

Surgery:

• Greater than 1 week since prior exploratory or palliative bypass surgery
• No prior Whipple procedure or surgical procedure for curative intent

Other:

• No oral hypoglycemic agents

Patient Characteristics:

Age:

• 18 to physiologic 65

Performance status:

• ECOG 0-2

Life expectancy:

• More than 2 months

Hematopoietic:

• WBC greater than 3,000/mm³
• Platelet count greater than 100,000/mm³

Hepatic:

• Bilirubin less than 2.5 times normal
• SGOT or SGPT less than 1.5 times normal
• Albumin greater than 3.2 g/dL

Renal:

• Creatinine less than 1.5 times normal
• BUN less than 1.5 times normal

Other:

• Not pregnant or nursing
• HIV negative
• No other serious medical or psychiatric illness that would preclude study participation
• No serious infection
• Ability to eat solid food three meals per day
• No allergy or intolerance to pork
• No prior illicit drug addiction
• At least one year since prior daily alcohol use
• At least one year since prior cigarette use
• Must have supportive live-in spouse or other family member

Expected Enrollment

Approximately 72-90 patients will be accrued for this study within 3 years.

Outline

This is an open-label study. Patients are stratified according to stage (II or III vs IV), performance status (0-1 vs 2) and nutritional status (well nourished or moderately malnourished vs severely malnourished). Patients are entered into 1 of 2 treatment arms at their choice:

• Arm I (Nutritional Arm): Patients receive pancreatic enzymes orally every 4 hours and at meals daily on days 1-16, followed by 5 days of rest. Patients receive magnesium citrate and Papaya Plus with the pancreatic enzymes. Additionally, patients receive nutritional supplementation with vitamins, minerals, trace elements, and animal glandular products 4 times per day on days 1-16, followed by 5 days of rest. Courses repeat every 21 days until death despite relapse. Patients consume a moderate vegetarian metabolizer diet during the course of therapy, which excludes red meat, poultry, and white sugar. Coffee enemas are performed twice a day, along with skin brushing daily, skin cleansing once a week with castor oil during the first 6 months of therapy, and a salt and soda bath each week. Patients also undergo a complete liver flush and a clean sweep and purge on a rotating basis each month during the 5 days of rest.



• Arm II (Chemotherapy Arm): Patients receive gemcitabine-based chemotherapy.

Quality of life is assessed at 0, 2, 6, and 12 months and then yearly thereafter.

Patients are followed at 1, 3, 7, and 12 months and then yearly thereafter.

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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