A Phase III Randomized, Placebo-Controlled, Double-Blind Study of Intravenous Calcium/Magnesium in Two Different Versions to Prevent Oxaliplatin-Induced Sensory Neurotoxicity
A Phase III Randomized, Placebo-Controlled, Double-Blind Study of Intravenous Calcium/Magnesium in Two Different Versions to Prevent Oxaliplatin-Induced Sensory Neurotoxicity
RATIONALE: Chemoprotective drugs, such as calcium gluconate and magnesium sulfate, may prevent neurotoxicity caused by oxaliplatin. It is not yet known which administration schedule of calcium gluconate and magnesium sulfate is more effective in preventing neurotoxicity.
PURPOSE: This randomized phase III trial is studying different administration schedules of calcium gluconate and magnesium sulfate and comparing how well they work in neurotoxicity in patients with colon cancer or rectal cancer receiving oxaliplatin-based combination chemotherapy.
OBJECTIVES:
Primary
Secondary
Tertiary
OUTLINE: This is a multicenter study. Patients are stratified according to age (< 65 years vs ≥ 65 years), gender, regimen (FOLFOX4 vs modified FOLFOX6 vs other), and stage of disease (II vs III vs IV). Patients are randomized to 1 of 3 treatment arms.
In all arms, courses repeat every 14 days for 6 months in the absence of disease progression or unacceptable toxicity.
Blood samples are collected before the second course of treatment for translational research.
Patients complete questionnaires on side effects, quality of life, and chemotherapy-induced peripheral neuropathy periodically.
After completion of study treatment, patients are followed up at 3, 6, 12, and 18 months.
DISEASE CHARACTERISTICS:
Histologically confirmed adenocarcinoma of the colon or rectum
Has undergone curative resection and is considered to have stage II or III disease or completely resected stage IV disease with no evidence of residual tumor
Scheduled to receive 6 months of oxaliplatin-based adjuvant chemotherapy with 85 mg/m^2 oxaliplatin every 2 weeks (this includes, for instance, FOLFOX4 or modified FOLFOX6)
PATIENT CHARACTERISTICS:
ECOG performance status 0-2
WBC ≥ 3,000/mm^3
ANC ≥ 1,500/mm^3
Platelet count ≥ 100,000/mm^3
Hemoglobin ≥ 10.0 g/dL
Total bilirubin ≤ 1.5 times upper limit of normal (ULN)
Serum creatinine ≤ 1.5 times ULN
Serum calcium ≤ 1.2 times ULN
Serum magnesium ≤ 1.2 times ULN
Not pregnant or nursing
Negative pregnancy test
Fertile patients must use effective contraception
Able to complete questionnaires (alone or with assistance)
Able to comply with study treatment
Willing to return to enrolling institution for follow-up
Willing to provide blood sample for research purposes
No pre-existing peripheral neuropathy of any grade
No family history of a genetic/familial neuropathy
No second or third degree AV heart block or a history of second or third degree heart block
No other medical conditions that, in the opinion of the treating physician, would make this protocol unreasonably hazardous for the patient
PRIOR CONCURRENT THERAPY:
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San Francisco, California 94115, United States
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