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Sponsors and Collaborators: |
Herbert Irving Comprehensive Cancer Center National Center for Complementary and Alternative Medicine (NCCAM) |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00003851 |
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 | Intervention |
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Cancer-Related Problem/Condition Pancreatic Cancer |
Drug: gemcitabine hydrochloride Drug: proteolytic enzymes Procedure: Gonzalez regimen |
Study Type: | Interventional |
Study Design: | Treatment, Open Label |
Official Title: | Evaluation of Intensive Pancreatic Proteolytic Enzyme Therapy With Ancillary Nutritional Support Versus Gemcitabine Chemotherapy in the Treatment of Inoperable Pancreatic Adenocarcinoma |
Estimated Enrollment: | 90 |
Study Start Date: | March 1999 |
OBJECTIVES:
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:
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.
Ages Eligible for Study: | 18 Years to 65 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically confirmed unresectable primary or metastatic adenocarcinoma of the pancreas diagnosed within the past 8 weeks
PATIENT CHARACTERISTICS:
Age:
Performance status:
Life expectancy:
Hematopoietic:
Hepatic:
Renal:
Other:
PRIOR CONCURRENT THERAPY:
Biologic therapy:
Chemotherapy:
Endocrine therapy:
No concurrent hormonal therapy except:
Radiotherapy:
Surgery:
Other:
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 |
Study ID Numbers: | CDR0000067012, CPMC-IRB-8544, NCCAM, NCI-V99-1538 |
Study First Received: | November 1, 1999 |
Last Updated: | October 18, 2008 |
ClinicalTrials.gov Identifier: | NCT00003851 |
Health Authority: | United States: Federal Government |
malnutrition stage II pancreatic cancer stage III pancreatic cancer stage IV pancreatic cancer adenocarcinoma of the pancreas |
Digestive System Diseases Digestive System Neoplasms Malnutrition Pancreatic Neoplasms Endocrine System Diseases Pancreatic Diseases |
Gastrointestinal Neoplasms Endocrinopathy Gemcitabine Adenocarcinoma Pancrelipase Endocrine Gland Neoplasms |
Antimetabolites Anti-Infective Agents Antimetabolites, Antineoplastic Molecular Mechanisms of Pharmacological Action Immunologic Factors Antineoplastic Agents Physiological Effects of Drugs Enzyme Inhibitors |
Antiviral Agents Immunosuppressive Agents Pharmacologic Actions Neoplasms Neoplasms by Site Radiation-Sensitizing Agents Therapeutic Uses |