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(1-800-422-6237).
Phase III Study of Gemcitabine Versus Intensive Pancreatic Proteolytic
Enzyme Therapy with Ancillary Nutritional Support in Patients With Stage II,
III, or IV Adenocarcinoma of the Pancreas (Summary Last Modified 07/2000)
Protocol IDs:
CPMC-IRB-8544, NCI-V99-1538
Protocol Type:
supportive care , treatment
Sponsorship:
Other
Status:
Active
Age Range:
18 to physiologic 65
Objectives
I. 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.
II. Assess quality of life in these patients.
Protocol Entry Criteria
--Disease Characteristics--
Histologically confirmed unresectable primary or metastatic adenocarcinoma of
the pancreas diagnosed within the past 8 weeks
Stage II-IV
--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
--Patient Characteristics--
Age:
18 to physiologic 65
Performance status:
ECOG 0-2
Life expectancy:
Greater than 2 months
Hematopoietic:
WBC greater than 3,000/mm3
Platelet count greater than 100,000/mm3
Hepatic:
Bilirubin less than 1.5 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
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
Protocol Outline
This is an open label study. Patients are stratified by 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 one of two 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 IV over 30 minutes
once weekly for 7 weeks, followed by 1 week of rest. Subsequent courses are
given over 30 minutes once weekly for 3 consecutive weeks, followed by 1 week
of rest. Patients receive a minimum of 2 courses in the absence of disease
progression.
Quality of life is assessed at 0, 2, 6, and 12 months and yearly thereafter.
Patients are followed at 1, 3, 7, and 12 months and yearly thereafter.
Stratification By
Not abstracted
Special Study Parameters
Not abstracted
End Points
Not abstracted
Projected Accrual
Approximately 72-90 patients will be accrued for this study within 3 years.
Warning
The purpose of most clinical trials listed in this database is to test new
cancer treatments, or new methods of diagnosing, screening, or preventing
cancer. Because all potentially harmful side effects are not known before a
trial is conducted, dose and schedule modifications may be required for
participants if they develop side effects from the treatment or test. The
therapy or test described in this clinical trial is intended for use by
clinical oncologists in carefully structured settings, and may not prove to be
more effective than standard treatment. A responsible investigator associated
with this clinical trial should be consulted before using this protocol.
Dosage Schedule
Not abstracted
Dosage Forms
Not abstracted
Participating Organizations/Investigators
John Chabot, Chair, Ph: 212-305-9468 Herbert Irving Comprehensive Cancer
Center
Principal Investigators
U.S.A.
New York
Karen H. Antman, Principal Investigator, Ph: 212-305-8602 Herbert Irving
Comprehensive Cancer Center New York, New York, U.S.A.
