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NCT Number: NCT00183846

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.

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

U.S.C./Norris Cancer Center

Los Angeles, California, 90033, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Irinotecan

Drug

Radiation Therapy

Procedure

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

  1. To describe the toxicity profile observed with this combination

  2. To obtain preliminary information related to the efficacy of this combination

Sponsors and collaborators

Lead sponsor

University of Southern California

Other

Registry information

Official study title

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

Important dates

Study start
2000
Primary completion
2007
Study completion
2009
First posted
Sep 16, 2005
Registry last updated
May 22, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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