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Evaluation of Intensive Pancreatic Proteolytic Enzyme Therapy With Ancillary Nutritional Support Versus Gemcitabine Chemotherapy in the Treatment of Inoperable Pancreatic Adenocarcinoma


N/A
18 Years
65 Years
Not Enrolling
Both
Malnutrition, Pancreatic Cancer

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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 UniversityNew York, New York  10032