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 has been terminated.
(Approval lapse)
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Columbia University
ClinicalTrials.gov Identifier:
NCT00003851
First received: November 1, 1999
Last updated: February 13, 2013
Last verified: February 2013
  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: This clinical trial is comparing 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 Intervention
Malnutrition
Pancreatic Cancer
Biological: proteolytic enzymes
Drug: gemcitabine hydrochloride
Procedure: Gonzalez regimen

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Evaluation of Intensive Pancreatic Proteolytic Enzyme Therapy With Ancillary Nutritional Support Versus Gemcitabine Chemotherapy in the Treatment of Inoperable Pancreatic Adenocarcinoma

Resource links provided by NLM:


Further study details as provided by Columbia University:

Estimated Enrollment: 90
Study Start Date: March 1999
Study Completion Date: July 2004
Primary Completion Date: July 2004 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Nutritional Arm
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.
Biological: proteolytic enzymes Procedure: Gonzalez regimen
Active Comparator: Chemotherapy Arm
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.
Drug: gemcitabine hydrochloride

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00003851

Locations
United States, New York
Herbert Irving Comprehensive Cancer Center at Columbia University
New York, New York, United States, 10032
Sponsors and Collaborators
Columbia University
Investigators
Study Chair: John Chabot, MD Herbert Irving Comprehensive Cancer Center
  More Information

Publications:
Responsible Party: Columbia University
ClinicalTrials.gov Identifier: NCT00003851     History of Changes
Other Study ID Numbers: AAAA8471, CPMC-IRB-8544, NCCAM, NCI-V99-1538
Study First Received: November 1, 1999
Last Updated: February 13, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Columbia University:
malnutrition
stage II pancreatic cancer
stage III pancreatic cancer
stage IV pancreatic cancer
adenocarcinoma of the pancreas

Additional relevant MeSH terms:
Malnutrition
Nutrition Disorders
Pancreatic Neoplasms
Digestive System Diseases
Digestive System Neoplasms
Endocrine Gland Neoplasms
Endocrine System Diseases
Neoplasms
Neoplasms by Site
Pancreatic Diseases
Gemcitabine
Anti-Infective Agents
Antimetabolites
Antimetabolites, Antineoplastic
Antineoplastic Agents
Antiviral Agents
Enzyme Inhibitors
Immunologic Factors
Immunosuppressive Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Radiation-Sensitizing Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on October 20, 2014