Study of Irinotecan Administered as a Continuous Infusion and Radiation Therapy for Upper Gastrointestinal Cancers
This study has been completed.
Sponsor:
USC/Norris Comprehensive Cancer Center
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
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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 1 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Safety Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Phase I Study of Irinotecan Administered as a Continuous Infusion and Radiation Therapy for Upper Gastrointestinal Cancers |
Resource links provided by NLM:
Further study details as provided by USC/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
USC/Norris Comprehensive Cancer Center
Investigators
| Principal Investigator: | Syma Iqbal, M.D. | U.S.C./Norris Comprehensive Cancer Center |
More Information
No publications provided
| ClinicalTrials.gov Identifier: | NCT00183846 History of Changes |
| Other Study ID Numbers: | 0C-00-8 |
| Study First Received: | September 9, 2005 |
| Last Updated: | January 10, 2008 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by USC/Norris Comprehensive Cancer Center:
|
pancreas stomach common bile duct cancer ampulla of Vater cancer |
Additional relevant MeSH terms:
|
Duodenal Neoplasms Stomach Neoplasms Pancreatic Neoplasms Gastrointestinal Neoplasms Bile Duct Neoplasms Intestinal Neoplasms Digestive System Neoplasms Neoplasms by Site Neoplasms Digestive System Diseases Gastrointestinal Diseases Duodenal Diseases Intestinal Diseases Stomach Diseases Endocrine Gland Neoplasms |
Pancreatic Diseases Endocrine System Diseases Biliary Tract Neoplasms Bile Duct Diseases Biliary Tract Diseases Irinotecan Antineoplastic Agents, Phytogenic Antineoplastic Agents Therapeutic Uses Pharmacologic Actions Radiation-Sensitizing Agents Physiological Effects of Drugs Topoisomerase I Inhibitors Topoisomerase Inhibitors Enzyme Inhibitors |
ClinicalTrials.gov processed this record on May 16, 2013