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
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ClinicalTrials.gov Identifier: NCT00003851 |
Recruitment Status :
Terminated
(Approval lapse)
First Posted : January 27, 2003
Last Update Posted : February 15, 2013
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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 or disease | Intervention/treatment | Phase |
---|---|---|
Malnutrition Pancreatic Cancer | Biological: proteolytic enzymes Drug: gemcitabine hydrochloride Procedure: Gonzalez regimen | Not Applicable |
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.
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 90 participants |
Allocation: | Non-Randomized |
Intervention Model: | Parallel Assignment |
Masking: | None (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 |
Study Start Date : | March 1999 |
Actual Primary Completion Date : | July 2004 |
Actual Study Completion Date : | July 2004 |

Arm | Intervention/treatment |
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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.
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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.
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Drug: gemcitabine hydrochloride |

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Ages Eligible for Study: | 18 Years to 65 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00003851
United States, New York | |
Herbert Irving Comprehensive Cancer Center at Columbia University | |
New York, New York, United States, 10032 |
Study Chair: | John Chabot, MD | Herbert Irving Comprehensive Cancer Center |
Responsible Party: | Columbia University |
ClinicalTrials.gov Identifier: | NCT00003851 |
Other Study ID Numbers: |
AAAA8471 CPMC-IRB-8544 NCCAM NCI-V99-1538 |
First Posted: | January 27, 2003 Key Record Dates |
Last Update Posted: | February 15, 2013 |
Last Verified: | February 2013 |
malnutrition stage II pancreatic cancer stage III pancreatic cancer stage IV pancreatic cancer adenocarcinoma of the pancreas |
Pancreatic Neoplasms Malnutrition Digestive System Neoplasms Neoplasms by Site Neoplasms Endocrine Gland Neoplasms Digestive System Diseases Pancreatic Diseases Endocrine System Diseases Nutrition Disorders Gemcitabine |
Antimetabolites, Antineoplastic Antimetabolites Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Antiviral Agents Anti-Infective Agents Enzyme Inhibitors Immunosuppressive Agents Immunologic Factors Physiological Effects of Drugs |