Ignite Creation Date:
2024-05-05 @ 10:18 AM
Last Modification Date:
2024-10-26 @ 9:04 AM
Study NCT ID:
NCT00003851
Status:
TERMINATED
Last Update Posted:
2013-02-15
First Post:
1999-11-01
Brief Title:
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
Sponsor:
Columbia University
Organization:
Columbia University
Study Overview
Official Title:
Evaluation of Intensive Pancreatic Proteolytic Enzyme Therapy With Ancillary Nutritional Support Versus Gemcitabine Chemotherapy in the Treatment of Inoperable Pancreatic Adenocarcinoma
Status:
TERMINATED
Status Verified Date:
2013-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Approval lapse
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| NCI-V99-1538 | None | None | None |
| CPMC-IRB-8544 | None | None | None |
| NCCAM | None | None | None |