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

• Status: Terminated
• Trial end date: 2004-07-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Columbia University
• Collaborator: National Center for Complementary and Integrative Health (NCCIH)
• Treatments: Gemcitabine

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