CTSU N08CB - "A Phase III Randomized, Placebo-Controlled, Double-Blind Study of Intravenous Calcium/Magnesium in Two Different Versions to Prevent Oxaliplatin-Induced Sensory Neuropathy"

NOTE:  See Section 6.3 for double-blinding procedures.

Treatment Plan    (Supplied Drugs:  None [Do not charge pt; sites will be reimbursed for cost of Ca Gluconate & Mg Sulfate])

RANDOMIZATION

Ca Gluconate + Mg Sulfate* immediately b/f & after chemo (FOLFOX)

vs

Placebo** immediately b/f & after chemo (FOLFOX)

vs

Ca Gluconate + Mg Sulfate* immediately b/f & placebo** immediately after chemo (FOLFOX)

   â

OBSERVATION/FOLLOW-UP

Q 3 mos x 6 mos after completion of chemo

Then questionnaires only at 12 & 18 mos post-chemo

*     1g of each agent, IV in 100ml D5W over 30 mins

**   100ml bag of D5W, IV over 30 mins

Eligibility

• Age >18.

• Histol-confirmed colon or rectum adenocarcinoma.

• Post curative resection & considered Stage II or III, or completely resected Stage IV w/no evidence of residual tumor.

• Scheduled to receive 6 mos of Oxaliplatin-based adjuv chemo w/85mg/m2 Oxaliplatin q 2 wks (i.e., FOLFOX4 or modified FOLFOX6 - see protocol for definitions).  Adjuv FOLFOX can be used w/ or w/o bolus 5FU.  Bevacizumab or Cetuximab in combination w/FOLFOX as part of a clinical trial or clinical practice is allowed.

• <28 days pre-regist:  WBC >3000; ANC >1500; platelets >100,000; Hgb >10.0; total bili & serum creat each <1.5x UNL; serum Ca & serum Mg each <1.2x UNL.

• Negative serum or urine pregnancy test <7 days pre-regist (if applicable).

• Able to complete questionnaires by themselves or w/assistance.

• ECOG perf status 0-2.

• Willing to return to enrolling site for follow-up.

• Willing to provide blood sample for research purposes (contact KCCOP for kit).

• Central venous line present (or scheduled to be placed) prior to starting chemo & protocol tx.

• No pregnant or nursing women.  Men/Women of reproductive potential must use effective contraception.

• No pre-existing perip neuropathy of any grade.

• No prior tx w/neurotoxic chemo (i.e., Oxaliplatin, Cisplatin, taxanes, or vinca alkaloids).

• No use of digitalis meds.

• No current or prior 2nd or 3rd degree AV heart block.  NOTE:  Bundle branch blocks are allowed.

• No tx w/anticonsulvants such as Tegretol, Dilantin, Depakrene, Neurontin, or other neurotropic agents such as Efffexor or Cymbalta.

• No other medical condition that would place pt at unreasonably hazardous risk on this protocol (investigator's opinion).

• No family hx of genetic/familial neuropathy.

• Must comply w/protocol.

• PRE-STUDY REQUIREMENTS (<28 days pre-regist): 

  • H&P, ht, wt, perf status, neurotoxicity eval (CTCAE version 4.0 & Oxaliplatin-specific Scale - see protocol)

  • Hgb, WBC, ANC, platelets

  • Serum Ca, Mg, Na, K, serum creat, SGOT, total bili, alk phos

  • CEA (if clinically indicated)

  • EKG (if clinically indicated)

  • Pregnancy test (serum or urine <7 days pre-regist; if applicable)

• Signed informed consent.