Calcium Gluconate and Magnesium Sulfate in Preventing Neurotoxicity in Patients With Colon Cancer or Rectal Cancer Receiving Oxaliplatin-Based Combination Chemotherapy
Condition: Chemotherapeutic Agent Toxicity; Colorectal Cancer; Neuropathy; Neurotoxicity
MeSH terms: Neurotoxicity Syndromes
Intervention: calcium gluconate; magnesium sulfate; placebo; oxaliplatin
Intervention description: Given IV; Given IV; Given IV
Intervention MeSH terms: Oxaliplatin; Magnesium Sulfate; Calcium
Phase: Phase 3
Study type: Interventional
Primary purpose: Supportive Care
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 362.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: neurotoxicity; neuropathy; chemotherapeutic agent toxicity; stage II colon cancer; stage III colon cancer; stage IV colon cancer; stage II rectal cancer; stage III rectal cancer; stage IV rectal cancer; adenocarcinoma of the colon; adenocarcinoma of the rectum

Summary:

      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.
    

Eligibility 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