Phase II Study to Assess Prevention of Oxaliplatin-induced Neurotoxicity Through the Vitamin D Pathway
18 Years
90 Years
Both
Neurotoxicity
Trial Information
Phase II Study to Assess Prevention of Oxaliplatin-induced Neurotoxicity Through the Vitamin D Pathway
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 survival. Despite these results, the use of Oxaliplatin is limited by the
sensory neuropathy or numbness and tingling, that occurs in 80% -90% of patients. Some of
these patients will develop irreversible and debilitating neuropathy, in which the drug may
no longer be used to treat their cancer.
It is expected that this proposed study will provide new information for the role of Vitamin
D in the pathogenesis of Oxaliplatin-induced neurotoxicity. The dynamic effects of Vitamin
D on calcium and nerve growth factor plus the now recognized state of subclinical Vitamin D
deficiency are compelling pieces of evidence that indicate this hormone may be in a pivotal
position in the multifactorial pathogenesis of neurotoxic reactions induced by Oxaliplatin.
The specific aim of the study is to determine the neuroprotective effects of Vitamin D.
Patients will receive Oxaliplatin at a dose of 80 mg/m2 at a physician determined frequency
appropriate for the underlying malignancy, which can be any histological diagnosis of a
malignant solid neoplasm involving the GI tract not restricted to the colon, rectum and
esophagus. Blood will be collected to monitor the level of Vitamin D and nerve growth
factor (NGF) at specific time points. Vitamin D levels will be checked once a month and NGF
levels will be checked bi-weekly. These blood samples will be collected at the same time of
the patients routine blood draws. Patients will take one capsule containing 2000 IUs of
Vitamin D3 daily, beginning up to 7 days prior to the first dose of Oxaliplatin. Vitamin D3
will be provided to patients as long as they remain on the study.
Inclusion Criteria:
- 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 Criteria:
- 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.
Type of Study:
Interventional
Study Design:
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Supportive Care
Outcome Measure:
Incidence of peripheral neurotoxic reactions
Outcome Description:
NCI CTCAE Version 4.0
Outcome Time Frame:
12 months
Safety Issue:
Yes
Principal Investigator
Gerald Higa, PharmD
Investigator Role:
Principal Investigator
Investigator Affiliation:
West Virginia University
Authority:
United States: Institutional Review Board
Study ID:
WVU 11011
NCT ID:
NCT01499940
Start Date:
October 2011
Completion Date:
October 2015
Related Keywords:
- Neurotoxicity
- peripheral neuropathy
- vitamin D status
- oxaliplatin
- Neurotoxicity Syndromes
Name | Location |
|---|---|
| West Virginia University Hospitals Mary Babb Randolph Cancer Center | Morgantown, West Virginia 26506 |
