A Phase III Randomized, Placebo-Controlled, Double-Blind Study of Intravenous Calcium/Magnesium in Two Different Versions to Prevent Oxaliplatin-Induced Sensory Neurotoxicity

Inclusion Criteria

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)

- Patients receiving bevacizumab or cetuximab in combination with FOLFOX as part
of a clinical trial or clinical practice are eligible

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

- Bundle branch blocks are allowed.

- No other medical conditions that, in the opinion of the treating physician, would
make this protocol unreasonably hazardous for the patient

PRIOR CONCURRENT THERAPY:

- See Disease Characteristics

- Central venous access line present, or scheduled to have a central line placed before
starting chemotherapy and study treatment

- No prior treatment with neurotoxic chemotherapy (e.g., oxaliplatin, cisplatin,
taxanes, or vinca alkaloids)

- No concurrent digitalis medication

- No concurrent treatment with the anticonvulsants carbamazepine (e.g., Tegretol®),
phenytoin (e.g., Dilantin®), valproic acid (e.g., Depakene®), gabapentin
(Neurontin®), or pregabalin (Lyrica®)

- No concurrent neurotropic agents, including venlafaxine (Effexor), desvenlafaxine
(Pristiq®), milnacipran (Savella®), or duloxetine (Cymbalta)

- No concurrent tricyclic antidepressants (such as amitryptilline), or any other agent
specifically being given to prevent or treat neuropathy

- No concurrent drugs given as a neuroprotectant