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Phase I Study of Irinotecan Administered as a Continuous Infusion and Radiation Therapy for Upper Gastrointestinal Cancers

Phase 1
18 Years
Not Enrolling
Pancreatic Cancer, Gastric Cancer, Duodenum Cancer, Bile Duct Cancer

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Trial Information

Phase I Study of Irinotecan Administered as a Continuous Infusion and Radiation Therapy for Upper Gastrointestinal Cancers

Inclusion Criteria:

- 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 Criteria:

- 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.

Type of Study:


Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

To determine the maximum tolerated dose of irinotecan when administered as a 5-day continuous infusion with concomitant radiation therapy in patients with upper gastrointestinal tumors (pancreas, stomach, duodenum, and common bile duct)

Principal Investigator

Syma Iqbal, M.D.

Investigator Role:

Principal Investigator

Investigator Affiliation:

U.S.C./Norris Comprehensive Cancer Center


United States: Institutional Review Board

Study ID:




Start Date:

December 2000

Completion Date:

July 2007

Related Keywords:

  • Pancreatic Cancer
  • Gastric Cancer
  • Duodenum Cancer
  • Bile Duct Cancer
  • pancreas
  • stomach
  • common bile duct cancer
  • ampulla of Vater cancer
  • Duodenal Neoplasms
  • Stomach Neoplasms
  • Pancreatic Neoplasms
  • Gastrointestinal Neoplasms
  • Bile Duct Neoplasms



U.S.C./Norris Cancer Center Los Angeles, California  90033