Phase II Interstitial Colloidal 32P Integrated in The Treatment of Non-Resectable Pancreatic Cancer
18 Years
N/A
Both
Pancreatic Cancer
Trial Information
Phase II Interstitial Colloidal 32P Integrated in The Treatment of Non-Resectable Pancreatic Cancer
OBJECTIVES:
- Determine the response/remission rate, survival, and degree of local control from
interstitial colloidal phosphorus P32 followed by external beam radiotherapy and
chemotherapy in patients with unresectable pancreatic cancer.
OUTLINE: Patients are stratified according to prior therapy (yes vs no).
Patients receive dexamethasone intratumorally, then macroaggregated albumin and interstitial
phosphorus P32 intratumorally. Most patients receive a second course of this brachytherapy.
Patients then proceed to chemoradiotherapy beginning 7-14 days after brachytherapy.
Radiotherapy is administered 5 days a week for 6.4 weeks. Fluorouracil IV is administered
every other day for 4 doses during weeks 1 and 2.
Patients are followed monthly for 1 year then every 3 months thereafter.
PROJECTED ACCRUAL: A total of 48 patients will be accrued for this study.
Inclusion Criteria
DISEASE CHARACTERISTICS:
- Histologically proven unresectable adenocarcinoma of the pancreas limited to the
head, body, or tail of the pancreas
- Diameter no greater than 5 cm
- Volume no greater than 66 mL
- No ascites (with or without tumor cells)
- No endoscopically proven tumor penetration of duodenum or stomach
PATIENT CHARACTERISTICS:
Age:
- 18 and over
Performance status:
- Karnofsky 70-100%
Hematopoietic:
- WBC at least 3,000/mm3
- Platelet count at least 100,000/mm3
- Hemoglobin at least 9 g/dL (transfusion allowed)
Hepatic:
- No hepatic disease
- At least 50% uptake of technetium-sulfur colloid in normal liver if cirrhosis
suspected
- No vascular occlusion of portal system
Renal:
- Creatinine no greater than 1.5 mg/dL
- BUN no greater than 25 mg/dL
Other:
- No Crohn's disease, ulcerative colitis, or other inflammatory bowel disease
- Not pregnant
PRIOR CONCURRENT THERAPY:
Biologic therapy:
- Not specified
Chemotherapy:
- If prior chemotherapy, test dose of colloidal phosphorous P32 administered prior to
attempted treatment
Endocrine therapy:
- Not specified
Radiotherapy:
- No prior radiotherapy to pancreas, liver, or upper gastrointestinal tract
Surgery:
- No complete surgical resection
- No splenectomy
Type of Study:
Interventional
Study Design:
Primary Purpose: Treatment
Outcome Measure:
Response rate
Safety Issue:
No
Principal Investigator
Stanley E. Order, MD, ScD, FACR
Investigator Role:
Study Chair
Investigator Affiliation:
Center for Molecular Medicine
Authority:
United States: Federal Government
Study ID:
CDR0000064415
NCT ID:
NCT00002689
Start Date:
September 1995
Completion Date:
Related Keywords:
- Pancreatic Cancer
- stage I pancreatic cancer
- stage II pancreatic cancer
- stage III pancreatic cancer
- adenocarcinoma of the pancreas
- Pancreatic Neoplasms
Name | Location |
|---|---|
| Northside Hospital Cancer Center | Atlanta, Georgia 30342-1611 |
| Center for Molecular Medicine | Garden City, New York 11530 |
