Calcium Gluconate and Magnesium Sulfate in Preventing Neurotoxicity Caused By Oxaliplatin in Patients Receiving Combination Chemotherapy for Stage II, Stage III, or Stage IV Colorectal Cancer That Has Been Completely Removed By Surgery
Condition: Colorectal Cancer; Neurotoxicity
MeSH terms: Colorectal Neoplasms; Neurotoxicity Syndromes
Intervention: calcium gluconate; magnesium sulfate; placebo
Intervention description: Given IV; Given IV; Given IV
Intervention MeSH terms: Magnesium Sulfate; Calcium
Phase: Phase 3
Study type: Interventional
Primary purpose: Supportive Care
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 104.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: neurotoxicity; stage II colon cancer; stage III colon cancer; adenocarcinoma of the colon; stage II rectal cancer; stage III rectal cancer; stage IV rectal cancer; stage IV colon cancer; adenocarcinoma of the rectum

Summary:

      RATIONALE: Calcium gluconate and magnesium sulfate may prevent or lessen neurotoxicity caused
      by oxaliplatin. It is not yet known whether calcium gluconate and magnesium sulfate are more
      effective than a placebo in preventing neurotoxicity caused by oxaliplatin in patients
      receiving combination chemotherapy.

      PURPOSE: This randomized phase III trial is studying calcium gluconate and magnesium sulfate
      to see how well they work compared to a placebo in preventing neurotoxicity caused by
      oxaliplatin in patients receiving combination chemotherapy for stage II, stage III, or stage
      IV colorectal cancer that has been completely removed by surgery.
    

Eligibility criteria:

        DISEASE CHARACTERISTICS:

          -  Histologically confirmed adenocarcinoma of the colon or rectum

               -  Stage II disease

               -  Stage III disease

               -  Stage IV disease (completely resected with no evidence of residual tumor)

          -  Must have undergone curative resection for stage II or III disease

          -  Scheduled to receive 6 months of adjuvant treatment with either of the following
             FOLFOX chemotherapy regimens:

               -  FOLFOX4, comprising leucovorin calcium, fluorouracil, and oxaliplatin (2-week
                  course)

               -  Modified FOLFOX6, comprising high-dose leucovorin calcium, high-dose
                  fluorouracil, and oxaliplatin (2-week course)

        PATIENT CHARACTERISTICS:

          -  Absolute neutrophil count ≥ 1,500/mm^3

          -  Platelet count ≥ 100,000/mm^3

          -  Hemoglobin ≥ 10 g/dL

          -  WBC ≥ 3,000/mm^3

          -  Bilirubin ≤ 1.5 times upper limit of normal (ULN)

          -  Creatinine ≤ 1.5 times ULN

          -  Calcium normal

          -  Not pregnant or nursing

          -  Negative pregnancy test

          -  Fertile patients must use effective contraception

          -  No pre-existing peripheral neuropathy of any grade

          -  No hypercalcemia

          -  No concurrent heart block or a history of heart block

          -  No other medical condition that, in the opinion of the treating physician, would make
             this protocol unreasonably hazardous for the patient

          -  No family history of a genetic/familial neuropathy

        PRIOR CONCURRENT THERAPY:

          -  See Disease Characteristics

          -  No prior treatment with neurotoxic chemotherapy such as oxaliplatin, cisplatin,
             taxanes, or vinca alkaloids

          -  Concurrent use of bevacizumab or cetuximab in combination with FOLFOX as part of a
             clinical trial or clinical practice are allowed

          -  No concurrent digitalis medication

          -  No concurrent digoxin

          -  No concurrent treatment with anticonvulsants such as carbamazepine, phenytoin, or
             valproic acid

          -  No other concurrent neurotropic agents such as gabapentin