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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
University of Southern California
ClinicalTrials.gov Identifier:
NCT00183846
First received: September 9, 2005
Last updated: May 20, 2014
Last verified: May 2014

September 9, 2005
May 20, 2014
December 2000
October 2007   (final data collection date for primary outcome measure)
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)
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).
Complete list of historical versions of study NCT00183846 on ClinicalTrials.gov Archive Site
  • To describe the toxicity profile observed with this combination
  • To obtain preliminary information related to the efficacy of this combination
  • To describe the toxicity profile observed with this combination.
  • To obtain preliminary information related to the efficacy of this combination.
Not Provided
Not Provided
 
Study of Irinotecan Administered as a Continuous Infusion and Radiation Therapy for Upper Gastrointestinal Cancers
Phase I Study of Irinotecan Administered as a Continuous Infusion and Radiation Therapy for Upper Gastrointestinal Cancers

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.

Not Provided
Interventional
Phase 1
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Pancreatic Cancer
  • Gastric Cancer
  • Duodenum Cancer
  • Bile Duct Cancer
  • Drug: irinotecan
  • Procedure: radiation therapy
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
22
July 2009
October 2007   (final data collection date for primary outcome measure)

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.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00183846
0C-00-8
Not Provided
University of Southern California
University of Southern California
Not Provided
Principal Investigator: Syma Iqbal, M.D. U.S.C./Norris Comprehensive Cancer Center
University of Southern California
May 2014

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