Evaluation of Intensive Pancreatic Proteolytic Enzyme Therapy With Ancillary Nutritional Support Versus Gemcitabine Chemotherapy in the Treatment of Inoperable Pancreatic Adenocarcinoma
18 Years
65 Years
Both
Malnutrition, Pancreatic Cancer
Trial Information
Evaluation of Intensive Pancreatic Proteolytic Enzyme Therapy With Ancillary Nutritional Support Versus Gemcitabine Chemotherapy in the Treatment of Inoperable Pancreatic Adenocarcinoma
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.
Inclusion 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
Type of Study:
Interventional
Study Design:
Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Principal Investigator
John Chabot, MD
Investigator Role:
Study Chair
Investigator Affiliation:
Herbert Irving Comprehensive Cancer Center
Authority:
United States: Institutional Review Board
Study ID:
AAAA8471
NCT ID:
NCT00003851
Start Date:
March 1999
Completion Date:
July 2004
Related Keywords:
- Malnutrition
- Pancreatic Cancer
- malnutrition
- stage II pancreatic cancer
- stage III pancreatic cancer
- stage IV pancreatic cancer
- adenocarcinoma of the pancreas
- Adenocarcinoma
- Pancreatic Neoplasms
- Malnutrition
Name | Location |
|---|---|
| Herbert Irving Comprehensive Cancer Center at Columbia University | New York, New York 10032 |
