Clinical trial NCT01099449 (phase 3, status: completed)
Conditions: chemotherapeutic agent toxicity, colorectal cancer, neuropathy, neurotoxicity
ICD codes: C05.2, C10.0, C16.0, C16.4, C17.0, C17.1, C17.2, G58.0, G61.1, A52.15, G60.3, G61.82, H46.2, H46.3, G92.00, G92.01, G92.02, G92.03, G92.04, G92.05
Drugs: calcium gluconate, magnesium sulfate, oxaliplatin
SMILES: [Ca], [MgH2], [H][N]1([H])[C@@H]2CCCC[C@H]2[N]([H])([H])[Pt]11OC(=O)C(=O)O1
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