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

Pancreatic Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00183846
• Other study ID #: 0C-00-8
• Status: Completed
• Phase: Phase 1
• First received: September 9, 2005
• Last updated: May 20, 2014
• Start date: December 2000
• Est. completion date: July 2009

Study information

• Verified date: May 2014
• Source: University of Southern California
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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 cancer in combination with a chemotherapy drug, called 5-fluorouracil (5-FU). In this study, doctors will administer the standard dose of radiation therapy in combination with an investigational chemotherapy drug, called irinotecan. Irinotecan can decrease the size of tumors and also appears to increase the effectiveness of radiation. The purpose of this study is to determine the highest dose of irinotecan that can be given safely in combination with radiation therapy, and to determine the side effects when these two treatments are given together. Irinotecan is approved by the Food and Drug Administration (FDA) for the treatment of colon cancer, but is not approved for cancers of the digestive tract. However, the FDA is allowing its use in this research study.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 22
• Est. completion date: July 2009
• Est. primary completion date: October 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Bile Duct Cancer
• Cholangiocarcinoma
• Duodenal Neoplasms
• Duodenum Cancer
• Gastric Cancer
• Gastrointestinal Neoplasms
• Pancreatic Cancer
• Pancreatic Neoplasms

Intervention

Drug:
• irinotecan

Procedure:
• radiation therapy

Locations

Country	Name	City	State
United States	U.S.C./Norris Cancer Center	Los Angeles	California

Sponsors (1)

Lead Sponsor	Collaborator
University of Southern California

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)
Secondary	To describe the toxicity profile observed with this combination
Secondary	To obtain preliminary information related to the efficacy of this combination