Status:
TERMINATED
Study to Assess Prevention of Oxaliplatin-induced Neurotoxicity Through Vitamin D Pathway
Lead Sponsor:
Gerald Higa, PharmD.
Conditions:
Neurotoxicity
Eligibility:
All Genders
18-90 years
Phase:
PHASE2
Brief Summary
Many patients with cancer that are treated with a drug called oxaliplatin. This drug is used with other drugs to treat cancer. The drug can cause problems with the nerves in the hands and feet called ...
Detailed Description
Oxaliplatin is used most frequently in patients with metastatic and early-stage colorectal cancers. It has been found that in the adjuvant setting, Oxaliplatin improves both disease free and overall s...
Eligibility Criteria
Inclusion
- Have a histologic diagnosis of a malignant solid neoplasm involving the gastrointestinal tract not necessarily restricted to the colon, rectum, and esophagus,
- Will receive oxaliplatin-based chemotherapy for the first time (previous treatment with non-oxaliplatin-based chemotherapy does not preclude eligibility),
- Have disease of any stage and will be treated according to established standards,
- Have a performance status (ECOG) of 2 or less,
- Have intact organ function as determined by laboratory tests of the kidney, liver, and bone marrow deemed appropriate to receive cytotoxic chemotherapy,
- Are 18 years of age or older, and
- Have signed a consent and information form to participate in the study.
Exclusion
- Are pregnant (subjects of childbearing age will have a pregnancy test performed),
- Are taking calcitriol or have vitamin D levels that are \>100 ng/dL,
- Are receiving medication for seizures, or
- Have pre-existing peripheral neuropathy grade \>1.
Key Trial Info
Start Date :
January 1 2012
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2012
Estimated Enrollment :
9 Patients enrolled
Trial Details
Trial ID
NCT01499940
Start Date
January 1 2012
End Date
December 1 2012
Last Update
November 10 2021
Active Locations (1)
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1
West Virginia University Hospitals Mary Babb Randolph Cancer Center
Morgantown, West Virginia, United States, 26506