NCT00003851

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.

Trial Health

57
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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
90

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Mar 1999

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 1999

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

November 1, 1999

Completed
3.2 years until next milestone

First Posted

Study publicly available on registry

January 27, 2003

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2004

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2004

Completed
Last Updated

February 15, 2013

Status Verified

February 1, 2013

Enrollment Period

5.3 years

First QC Date

November 1, 1999

Last Update Submit

February 13, 2013

Conditions

MalnutritionPancreatic Cancer

Keywords

malnutritionstage II pancreatic cancerstage III pancreatic cancerstage IV pancreatic canceradenocarcinoma of the pancreas

Study Arms (2)

Nutritional Arm

ACTIVE COMPARATOR

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 enzymesProcedure: Gonzalez regimen

Chemotherapy Arm

ACTIVE COMPARATOR

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

Interventions

proteolytic enzymesBIOLOGICAL
Nutritional Arm
gemcitabine hydrochlorideDRUG
Chemotherapy Arm
Gonzalez regimenPROCEDURE
Nutritional Arm

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (1)

Herbert Irving Comprehensive Cancer Center at Columbia University

New York, New York, 10032, United States

Location

Related Publications (1)

  • 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.

    PMID: 19687327RESULT

MeSH Terms

Conditions

MalnutritionPancreatic Neoplasms

Interventions

Peptide HydrolasesGemcitabine

Condition Hierarchy (Ancestors)

Nutrition DisordersNutritional and Metabolic DiseasesDigestive System NeoplasmsNeoplasms by SiteNeoplasmsEndocrine Gland NeoplasmsDigestive System DiseasesPancreatic DiseasesEndocrine System Diseases

Intervention Hierarchy (Ancestors)

HydrolasesEnzymesEnzymes and CoenzymesHeterocyclic CompoundsDeoxycytidineCytidinePyrimidine NucleosidesPyrimidinesHeterocyclic Compounds, 1-Ring

Study Officials

  • John Chabot, MD

    Herbert Irving Comprehensive Cancer Center

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 1, 1999

First Posted

January 27, 2003

Study Start

March 1, 1999

Primary Completion

July 1, 2004

Study Completion

July 1, 2004

Last Updated

February 15, 2013

Record last verified: 2013-02

Locations

US(1)