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| Sponsor: | University of Washington |
|---|---|
| Collaborator: |
National Cancer Institute (NCI) |
| Information provided by: | National Cancer Institute (NCI) |
| ClinicalTrials.gov Identifier: | NCT00030563 |
Purpose
RATIONALE: Radiofrequency ablation uses high-frequency electric current to kill tumor cells. Combining radiofrequency ablation with surgery may kill more tumor cells. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Giving a chemotherapy drug after surgery and radiofrequency ablation may kill any remaining tumor cells.
PURPOSE: Phase II trial to determine the effectiveness of surgery with or without radiofrequency ablation followed by irinotecan in treating patients who have colorectal cancer that is metastatic to the liver.
| Condition | Intervention | Phase |
|---|---|---|
|
Colorectal Cancer Metastatic Cancer |
Drug: irinotecan hydrochloride Procedure: adjuvant therapy Procedure: conventional surgery Procedure: radiofrequency ablation |
Phase II |
| Study Type: | Interventional |
| Study Design: | Treatment |
| Official Title: | A Phase II Study Of Adjuvant Intravenous Irinotecan Following Resection With Or Without Radiofrequency Ablation (RFA), Of Hepatic Metastases From Colorectal Carcinoma |
| Study Start Date: | May 2001 |
OBJECTIVES:
OUTLINE: This is a multicenter study. Patients are stratified according to treatment with radiofrequency ablation in addition to resection (yes vs no).
Patients undergo surgical resection with or without radiofrequency ablation. Beginning 4-8 weeks after surgery, patients receive irinotecan IV over 90 minutes on day 1. Chemotherapy repeats every 3 weeks for a total of 6 courses in the absence of disease progression or unacceptable toxicity.
Patients are followed at 4 weeks, every 3 months for 2 years, every 6 months for 3 years, and then annually thereafter.
PROJECTED ACCRUAL: A total of 70 patients will be accrued for this study.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Hepatic metastases that are considered completely resectable
Hepatic metastases that are not completely resectable but are amenable to complete destruction with resection and radiofrequency ablation
PATIENT CHARACTERISTICS:
Age:
Performance status:
Life expectancy:
Hematopoietic:
Hepatic:
Renal:
Cardiovascular:
Other:
PRIOR CONCURRENT THERAPY:
Biologic therapy:
Chemotherapy:
Endocrine therapy:
Radiotherapy:
Surgery:
Other:
Contacts and Locations| United States, Ohio | |
| Ireland Cancer Center | |
| Cleveland, Ohio, United States, 44106-5065 | |
| United States, Washington | |
| University of Washington School of Medicine | |
| Seattle, Washington, United States, 98195 | |
| Canada, Ontario | |
| Princess Margaret Hospital | |
| Toronto, Ontario, Canada, M5G 2M9 | |
| Study Chair: | Kevin G. Billingsley, MD | University of Washington |
More Information
| Study ID Numbers: | CDR0000069177, UWASH-1200, CWRU-040106, UWASH-440E-ONC-0020-250, NCI-G01-2045, CWRU-UWMC-1200 |
| Study First Received: | February 14, 2002 |
| Last Updated: | February 6, 2009 |
| ClinicalTrials.gov Identifier: | NCT00030563 History of Changes |
| Health Authority: | United States: Federal Government |
|
liver metastases stage IV colon cancer stage IV rectal cancer adenocarcinoma of the colon |
adenocarcinoma of the rectum recurrent colon cancer recurrent rectal cancer |
|
Immunologic Factors Molecular Mechanisms of Pharmacological Action Gastrointestinal Diseases Antineoplastic Agents Colonic Diseases Irinotecan Physiological Effects of Drugs Rectal Diseases Neoplastic Processes Neoplasms by Site Pathologic Processes Therapeutic Uses Neoplasm Metastasis |
Digestive System Neoplasms Adjuvants, Immunologic Enzyme Inhibitors Intestinal Diseases Intestinal Neoplasms Camptothecin Pharmacologic Actions Neoplasms Digestive System Diseases Gastrointestinal Neoplasms Antineoplastic Agents, Phytogenic Colorectal Neoplasms |