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

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Trial Conditions
  • Chemotherapeutic Agent Toxicity
  • Colorectal Cancer
  • Neuropathy
  • Neurotoxicity
What is the purpose of this trial?

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.

Date & Status

Active, not recruiting

Who can Participate?

Eligibility

Ages:
18 and older

Gender:
Both

Eligibility

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

Gender: Both
Steward Physician(s)
  • Charles L. Loprinzi, MD
Facilities
  • St. Elizabeth's Medical Center - Active, not recruiting
Trial Interventions
Drug
  • calcium gluconate
  • magnesium sulfate
Other
  • placebo
Physician Researcher

Investigator Name:

  • Charles L. Loprinzi, MD

Other Information

Sponsor: North Central Cancer Treatment Group
Phase: Phase 3
Trial ID: NCT01099449
Volunteers:  Not Accepting Healthy Volunteers

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