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

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ClinicalTrials.gov Identifier: NCT00183846
Recruitment Status : Completed
First Posted : September 16, 2005
Last Update Posted : May 22, 2014
Information provided by (Responsible Party):
University of Southern California

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.

Condition or disease Intervention/treatment Phase
Pancreatic Cancer Gastric Cancer Duodenum Cancer Bile Duct Cancer Drug: irinotecan Procedure: radiation therapy Phase 1

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 22 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase I Study of Irinotecan Administered as a Continuous Infusion and Radiation Therapy for Upper Gastrointestinal Cancers
Study Start Date : December 2000
Primary Completion Date : October 2007
Study Completion Date : July 2009

Primary Outcome Measures :
  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 Outcome Measures :
  1. To describe the toxicity profile observed with this combination
  2. To obtain preliminary information related to the efficacy of this combination

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00183846

United States, California
U.S.C./Norris Cancer Center
Los Angeles, California, United States, 90033
Sponsors and Collaborators
University of Southern California
Principal Investigator: Syma Iqbal, M.D. U.S.C./Norris Comprehensive Cancer Center

Responsible Party: University of Southern California
ClinicalTrials.gov Identifier: NCT00183846     History of Changes
Other Study ID Numbers: 0C-00-8
First Posted: September 16, 2005    Key Record Dates
Last Update Posted: May 22, 2014
Last Verified: May 2014

Keywords provided by University of Southern California:
common bile duct cancer
ampulla of Vater cancer

Additional relevant MeSH terms:
Pancreatic Neoplasms
Stomach Neoplasms
Gastrointestinal Neoplasms
Bile Duct Neoplasms
Duodenal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Endocrine Gland Neoplasms
Digestive System Diseases
Pancreatic Diseases
Endocrine System Diseases
Gastrointestinal Diseases
Stomach Diseases
Biliary Tract Neoplasms
Bile Duct Diseases
Biliary Tract Diseases
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Intestinal Neoplasms
Duodenal Diseases
Intestinal Diseases
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Topoisomerase I Inhibitors