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Sponsors and Collaborators: |
University of Cincinnati MedImmune LLC AstraZeneca |
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Information provided by: | University of Cincinnati |
ClinicalTrials.gov Identifier: | NCT00601198 |
The purpose of this study is to determine the effect of amifostine (ETHYOL) on decreasing the rate and severity of nerve dysfunction or neuropathy (numbness and tingling in hands and feet) associated with FOLFOX chemotherapy.
Condition | Intervention | Phase |
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Colorectal Cancer |
Drug: Amifostine |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Single Group Assignment, Efficacy Study |
Official Title: | Phase II Study of the Efficacy of Amifostine (Ethyol) in Reducing the Incidence and Severity of Oxaliplatin-Induced Neuropathy in Patients With Colorectal Cancer |
Estimated Enrollment: | 97 |
Study Start Date: | October 2006 |
Estimated Study Completion Date: | October 2009 |
Estimated Primary Completion Date: | October 2008 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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Treatment Period: Experimental
The chemotherapy regimen will be given for 2 consecutive days. On day #1, pt. will be premedicated with drugs to prevent nausea and vomiting in addition to intravenous fluids. Then they will receive amifostine intravenously followed by oxaliplatin, 5FU and leucovorin. This will be followed by an infusion of 5FU given in a pump over 22 hours. If the doctor decides on giving the pt. Avastin, this will be given on day #1. On day #2, they will receive the same treatment except for oxaliplatin.
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Drug: Amifostine
Patients should be treated with oxaliplatin-based chemotherapy in combination with amifostine for 12 cycles, or until unacceptable toxicity is observed or disease progression
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In addition, this study will provide information on how subjects with colorectal cancer do while receiving amifostine in combination with other chemotherapy drugs. This study will also look at the frequency of complications associated with amifostine and chemotherapy.
The FOLFOX chemotherapy regimen consists of three drugs, 5-FU, leucovorin, and oxaliplatin, all given intravenously (into the vein) every 2 weeks with or without Avastin given in combination with chemotherapy. FOLFOX has been approved by the Food and Drug Administration (FDA) for the treatment of cancer of the colon or rectum.
Amifostine is not a chemotherapy drug. It is approved by the Food and Drug Administration (FDA) to prevent moderate or severe dryness of the mouth caused by radiation treatment for head and neck cancer, and to prevent kidney damage caused by cisplatin chemotherapy treatment for ovarian and non-small cell lung cancer. Amifostine is not FDA approved for use in this study and is therefore considered investigational.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Tammy S Roads | 513-558-2192 | roadst.@ucmail.uc.edu |
Contact: Leslie Oleksowicz, MD | 513-558-2107 | Leslie.Oleksowicz@ucmail.uc.edu |
United States, Ohio | |
University of Cincinnati Dept. of Medicine, Div. Hem/Onc | Recruiting |
Cincinnati, Ohio, United States, 45267 | |
Contact: Andrea Hogan 513-584-6403 hoganaj@ucmail.uc.edu | |
Contact: Leslie Oleksowicz, MD 513-558-210 leslie.oleksowicz@uc.edu | |
Principal Investigator: Leslie Oleksowicz, MD |
Principal Investigator: | Leslie Oleksowicz, MD | University of Cincinnati |
Responsible Party: | University of Cincinnati ( University of Cincinnati ) |
Study ID Numbers: | ETH190-06, ETH190-06 |
Study First Received: | January 14, 2008 |
Last Updated: | February 24, 2009 |
ClinicalTrials.gov Identifier: | NCT00601198 History of Changes |
Health Authority: | United States: Institutional Review Board |
Oxaliplatin-induced Neuropathy Colon and rectum |
Radiation-Protective Agents Digestive System Neoplasms Amifostine Gastrointestinal Diseases Colonic Diseases Leucovorin Bevacizumab Intestinal Diseases |
Rectal Diseases Intestinal Neoplasms Calcium, Dietary Oxaliplatin Digestive System Diseases Fluorouracil Gastrointestinal Neoplasms Colorectal Neoplasms |
Radiation-Protective Agents Digestive System Neoplasms Amifostine Antineoplastic Agents Gastrointestinal Diseases Physiological Effects of Drugs Colonic Diseases Intestinal Diseases Protective Agents Rectal Diseases |
Pharmacologic Actions Intestinal Neoplasms Neoplasms Oxaliplatin Neoplasms by Site Digestive System Diseases Therapeutic Uses Gastrointestinal Neoplasms Colorectal Neoplasms |