RATIONALE: 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.

PURPOSE: Phase III trial to compare 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.

Condition	Treatment or Intervention	Phase
stage II pancreatic cancer stage III pancreatic cancer stage IV pancreatic cancer Nutrition adenocarcinoma of the pancreas	Drug: gemcitabine  Drug: proteolytic enzymes  Procedure: alternative product therapy  Procedure: biologically based therapies  Procedure: cancer prevention intervention  Procedure: chemotherapy  Procedure: complementary and alternative therapy  Procedure: nutritional support  Procedure: supportive care/therapy	Phase III

Further Study Details: 

OBJECTIVES:

• 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.
• Compare the quality of life in patients treated with these regimens.

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.

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

Ages Eligible for Study:  18 Years   -   65 Years,  Genders Eligible for Study:  Both

Criteria

DISEASE CHARACTERISTICS:

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

PATIENT CHARACTERISTICS: Age:

• 18 to physiologic 65

Performance status:

• ECOG 0-2

Life expectancy:

• More than 2 months

Hematopoietic:

• WBC greater than 3,000/mm^3
• Platelet count greater than 100,000/mm^3

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

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

New York
      Herbert Irving Comprehensive Cancer Center at Columbia University, New York,  New York,  10032,  United States; Recruiting

Study chairs or principal investigators

John Chabot, MD,  Study Chair,  Herbert Irving Comprehensive Cancer Center   

Study ID Numbers:  CDR0000067012; CPMC-IRB-8544; NCCAM; NCI-V99-1538; NCT00003851
Record last reviewed:  August 2004
Last Updated:  December 6, 2004
Record first received:  November 1, 1999
ClinicalTrials.gov Identifier:  NCT00003851
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-04-08