Clinical Trial: 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

This study is currently recruiting patients.

Sponsors and Collaborators: Herbert Irving Comprehensive Cancer Center
National Center for Complementary and Alternative Medicine (NCCAM)
Information provided by: National Cancer Institute (NCI)

Purpose

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

MedlinePlus related topics:  Pancreatic Cancer

Study Type: Interventional
Study Design: Treatment

Official Title: Phase III 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

Further Study Details: 

OBJECTIVES:

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.

Eligibility

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

Criteria

DISEASE CHARACTERISTICS:

PATIENT CHARACTERISTICS: Age:

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

Location and Contact Information


New York
      Herbert Irving Comprehensive Cancer Center at Columbia University, New York,  New York,  10032,  United States; Recruiting
John Chabot, MD  212-305-9468 

Study chairs or principal investigators

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

More Information

Clinical trial summary from the National Cancer Institute's PDQ® database

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


Source: ClinicalTrials.gov
Cache Date: April 9, 2005