A Study of Amifostine (Ethyol) in Patients With Colorectal Cancer
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|ClinicalTrials.gov Identifier: NCT00601198|
Recruitment Status : Terminated (Funding support withdrawn)
First Posted : January 25, 2008
Last Update Posted : March 23, 2010
|Condition or disease||Intervention/treatment||Phase|
|Colorectal Cancer||Drug: Amifostine||Phase 2|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||97 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
|Study Start Date :||October 2006|
|Actual Primary Completion Date :||February 2010|
|Actual Study Completion Date :||February 2010|
Experimental: Treatment Period
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.
Patients should be treated with oxaliplatin-based chemotherapy in combination with amifostine for 12 cycles, or until unacceptable toxicity is observed or disease progression
- Test drug in 28 patients. Trial will be terminated if 5 or more have grade 3 & 4 PSN. Will continue & add patients if 4 or fewer patients with grade 3 & 4 toxicity out of 28. [ Time Frame: 2 years ]
- Addition 69 patients will be studied. If total number of cumulative PSN is > or equal to 14, drug will be rejected. If less than 14 cases of cumulative PSN, declare drug effective in reducing 3rd & 4 grade toxicity by 50% [ Time Frame: 1 year ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00601198
|United States, Ohio|
|University of Cincinnati|
|Cincinnati, Ohio, United States, 45267|
|Principal Investigator:||Leslie Oleksowicz, MD||University of Cincinnati|