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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
Sponsor:
Collaborator:
National Center for Complementary and Integrative Health (NCCIH)
Information provided by (Responsible Party):
Columbia University

Tracking Information
First Submitted Date  ICMJE November 1, 1999
First Posted Date  ICMJE January 27, 2003
Last Update Posted Date February 15, 2013
Study Start Date  ICMJE March 1999
Actual Primary Completion Date July 2004   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE Not Provided
Original Primary Outcome Measures  ICMJE Not Provided
Change History Complete list of historical versions of study NCT00003851 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE 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
Official Title  ICMJE Evaluation of Intensive Pancreatic Proteolytic Enzyme Therapy With Ancillary Nutritional Support Versus Gemcitabine Chemotherapy in the Treatment of Inoperable Pancreatic Adenocarcinoma
Brief Summary

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.

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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Malnutrition
  • Pancreatic Cancer
Intervention  ICMJE
  • Biological: proteolytic enzymes
  • Drug: gemcitabine hydrochloride
  • Procedure: Gonzalez regimen
Study Arms  ICMJE
  • 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.
    Interventions:
    • 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.
    Intervention: Drug: gemcitabine hydrochloride
Publications * Chabot JA, Tsai WY, Fine RL, Chen C, Kumah CK, Antman KA, Grann VR. Pancreatic proteolytic enzyme therapy compared with gemcitabine-based chemotherapy for the treatment of pancreatic cancer. J Clin Oncol. 2010 Apr 20;28(12):2058-63. doi: 10.1200/JCO.2009.22.8429. Epub 2009 Aug 17.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Estimated Enrollment  ICMJE
 (submitted: April¬†9,¬†2007)
90
Original Enrollment  ICMJE Not Provided
Actual Study Completion Date  ICMJE July 2004
Actual Primary Completion Date July 2004   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00003851
Other Study ID Numbers  ICMJE AAAA8471
CPMC-IRB-8544
NCCAM
NCI-V99-1538
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Columbia University
Study Sponsor  ICMJE Columbia University
Collaborators  ICMJE National Center for Complementary and Integrative Health (NCCIH)
Investigators  ICMJE
Study Chair: John Chabot, MD Herbert Irving Comprehensive Cancer Center
PRS Account Columbia University
Verification Date February 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP