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

NCT00183846 | Completed Phase 1

• 1 other identifier: 0C-00-8
• Study Type: interventional
• Target: 22
• Locations: 1 country
• Sites: 1

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 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.

Conditions

Pancreatic Cancer; Gastric Cancer; Duodenum Cancer; Bile Duct Cancer

Keywords

pancreas; stomach; common bile duct cancer; ampulla of Vater cancer

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• To describe the toxicity profile observed with this combination

• To obtain preliminary information related to the efficacy of this combination

Interventions

irinotecan DRUG

radiation therapy PROCEDURE

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Southern California: lead

Study Sites (1)

U.S.C./Norris Cancer Center

Los Angeles, California, 90033, United States

Location

MeSH Terms

Conditions

Pancreatic Neoplasms; Stomach Neoplasms; Duodenal Neoplasms; Bile Duct Neoplasms

Interventions

Irinotecan; Radiotherapy

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Endocrine Gland Neoplasms; Digestive System Diseases; Pancreatic Diseases; Endocrine System Diseases; Gastrointestinal Neoplasms; Gastrointestinal Diseases; Stomach Diseases; Intestinal Neoplasms; Duodenal Diseases; Intestinal Diseases; Biliary Tract Neoplasms; Bile Duct Diseases; Biliary Tract Diseases

Intervention Hierarchy (Ancestors)

Camptothecin; Alkaloids; Heterocyclic Compounds; Therapeutics

Study Officials

• Syma Iqbal, M.D.

  U.S.C./Norris Comprehensive Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 9, 2005
• First Posted: September 16, 2005
• Study Start: December 1, 2000
• Primary Completion: October 1, 2007
• Study Completion: July 1, 2009
• Last Updated: May 22, 2014

Record last verified: 2014-05

Locations

US (1)