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

This study has been completed.

Sponsor:

Information provided by:

USC/Norris Comprehensive Cancer Center

ClinicalTrials.gov Identifier:

NCT00183846

First received: September 9, 2005

Last updated: January 10, 2008

Last verified: January 2008

History of Changes

Tracking Information

First Received Date ^ICMJE

September 9, 2005

Last Updated Date

January 10, 2008

Start Date ^ICMJE

December 2000

Primary Completion Date

Not Provided

Current Primary Outcome Measures ^ICMJE

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)

Original Primary Outcome Measures ^ICMJE

Change History

Complete list of historical versions of study NCT00183846 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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

Original Secondary Outcome Measures ^ICMJE

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

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

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.

Detailed Description

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Phase 1

Study Design ^ICMJE

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

Condition ^ICMJE

Pancreatic Cancer
Gastric Cancer
Duodenum Cancer
Bile Duct Cancer

Intervention ^ICMJE

Drug: irinotecan
Procedure: radiation therapy

Study Arm (s)

Not Provided

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Estimated Enrollment ^ICMJE

Completion Date

July 2007

Primary Completion Date

Not Provided

Eligibility Criteria ^ICMJE

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.

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT Number ^ICMJE

NCT00183846

Other Study ID Numbers ^ICMJE

0C-00-8

Has Data Monitoring Committee

Not Provided

Responsible Party

Not Provided

Study Sponsor ^ICMJE

USC/Norris Comprehensive Cancer Center

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Principal Investigator:

Syma Iqbal, M.D.

U.S.C./Norris Comprehensive Cancer Center

Information Provided By

USC/Norris Comprehensive Cancer Center

Verification Date

January 2008

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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