Status:
COMPLETED
Study of Irinotecan Administered as a Continuous Infusion and Radiation Therapy for Upper Gastrointestinal Cancers
Lead Sponsor:
University of Southern California
Conditions:
Pancreatic Cancer
Gastric Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
This study is for people with advanced cancer of the digestive tract and cancer that cannot be completely removed by surgery. Radiation therapy is commonly used in the treatment of these types of canc...
Eligibility Criteria
Inclusion
- Histologically confirmed neoplasm of the upper gastrointestinal tract (pancreas, stomach, duodenum, common bile duct, ampulla of Vater) or metastatic tumor to the upper abdomen.
- Eligible patients include patients with locally advanced unresectable tumors, positive surgical margins, local recurrence and resected stage II-III pancreatic, gastric, duodenum, bile duct or ampulla of Vater carcinoma.
- Performance status SWOG 0-2
- Fully recovered from prior surgery or chemotherapy (greater than or equal to 4 weeks). Patients previously treated with 5-FU or gemcitabine may start therapy 2 weeks after the last dose of 5-FU or gemcitabine.
- Absolute granulocyte count (AGC) \> 1500; platelets \> 100,000; serum creatinine \< 2.0 mg/dl; total bilirubin \< 2.0 mg/dl; AST or ALT and alkaline phosphatase \< 3 times the upper limit of normal.
- Prior chemotherapy is allowed.
Exclusion
- Prior radiation therapy to the upper abdomen
- Tumors of the gastroesophageal junction.
- Other medical, psychological or social circumstances that, in the opinion of the investigator, would prevent participation in the clinical trial
- Pregnancy.
Key Trial Info
Start Date :
December 1 2000
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2009
Estimated Enrollment :
22 Patients enrolled
Trial Details
Trial ID
NCT00183846
Start Date
December 1 2000
End Date
July 1 2009
Last Update
May 22 2014
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
U.S.C./Norris Cancer Center
Los Angeles, California, United States, 90033