Study of Irinotecan Administered as a Continuous Infusion and Radiation Therapy for Upper Gastrointestinal Cancers - Full Text View

Sponsored by:	Norris Comprehensive Cancer Center
Information provided by:	Norris Comprehensive Cancer Center
ClinicalTrials.gov Identifier:	NCT00183846

Purpose

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	Intervention	Phase
Pancreatic Cancer Gastric Cancer Duodenum Cancer Bile Duct Cancer	Drug: irinotecan Procedure: radiation therapy	Phase I

MedlinePlus related topics: Cancer Intestinal Cancer Pancreatic Cancer Stomach Cancer

Drug Information available for: Irinotecan Irinotecan hydrochloride Pancrelipase Ultrase

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Uncontrolled, Parallel Assignment, Safety Study
Official Title:	Phase I Study of Irinotecan Administered as a Continuous Infusion and Radiation Therapy for Upper Gastrointestinal Cancers

Further study details as provided by Norris Comprehensive Cancer Center:

Primary Outcome Measures:

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:

To describe the toxicity profile observed with this combination
To obtain preliminary information related to the efficacy of this combination

Estimated Enrollment:	20
Study Start Date:	December 2000
Study Completion Date:	July 2007

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00183846

Locations

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

Sponsors and Collaborators

Norris Comprehensive Cancer Center

Investigators

Principal Investigator:

Syma Iqbal, M.D.

U.S.C./Norris Comprehensive Cancer Center

More Information

Study ID Numbers:	0C-00-8
Study First Received:	September 9, 2005
Last Updated:	January 10, 2008
ClinicalTrials.gov Identifier:	NCT00183846
Health Authority:	United States: Institutional Review Board

Keywords provided by Norris Comprehensive Cancer Center:

pancreas
stomach
common bile duct cancer
ampulla of Vater cancer

Study placed in the following topic categories:

Biliary Tract Neoplasms
Digestive System Neoplasms
Gastrointestinal Diseases
Pancreatic Neoplasms
Irinotecan
Endocrine System Diseases
Stomach cancer
Intestinal Diseases
Pancrelipase
Intestinal Neoplasms
Duodenal Neoplasms

Digestive System Diseases
Stomach Diseases
Bile Duct Diseases
Biliary Tract Diseases
Stomach Neoplasms
Pancreatic Diseases
Gastrointestinal Neoplasms
Endocrinopathy
Bile Duct Neoplasms
Duodenal Diseases
Endocrine Gland Neoplasms

Additional relevant MeSH terms:

Neoplasms
Neoplasms by Site
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents

Therapeutic Uses
Enzyme Inhibitors
Antineoplastic Agents, Phytogenic
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 15, 2009