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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

Phase 3
18 Years
Open (Enrolling)
Chemotherapeutic Agent Toxicity, Colorectal Cancer, Neuropathy, Neurotoxicity

Thank you

Trial Information

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



- To determine whether 2 schedules of calcium gluconate and magnesium sulfate infusions
(given before and after chemotherapy or just before chemotherapy) can prevent or
ameliorate chronic, cumulative oxaliplatin-induced sensory neurotoxicity in patients
with colon or rectal cancer receiving adjuvant FOLFOX chemotherapy comprising
leucovorin calcium, fluorouracil, and oxaliplatin.


- To determine whether these 2 infusion schedules can increase the cumulative oxaliplatin
doses that can be delivered without dose-limiting chronic neurotoxicity.

- To determine whether these 2 infusion schedules can ameliorate acute neuropathy
associated with oxaliplatin.

- To determine whether these 2 infusion schedules cause adverse events.

- To investigate whether these 2 infusions schedules influence patient quality of life.

- To describe baseline and post-treatment neurological quantitative sensory testing
abnormalities in the study participants.


- To explore if polymorphisms in the GSTP1, GSTM1, ERCC2, and XRCC1 genes are associated
with early onset of oxaliplatin-induced neurotoxicity.

OUTLINE: This is a multicenter study. Patients are stratified according to age (< 65 years
vs ≥ 65 years), gender, regimen (FOLFOX4 vs modified FOLFOX6 vs other), and stage of disease
(II vs III vs IV). Patients are randomized to 1 of 3 treatment arms.

- Arm I: Patients receive calcium gluconate IV and magnesium sulfate IV over 30 minutes
immediately before and after oxaliplatin administration (part of FOLFOX chemotherapy
comprising leucovorin calcium, fluorouracil, and oxaliplatin).

- Arm II: Patients receive placebo IV over 30 minutes immediately before and after
oxaliplatin administration (part of FOLFOX chemotherapy).

- Arm III: Patients receive calcium gluconate and magnesium sulfate IV over 30 minutes
immediately before and placebo IV over 30 minutes immediately after oxaliplatin
administration (part of FOLFOX chemotherapy).

In all arms, courses repeat every 14 days for 6 months in the absence of disease progression
or unacceptable toxicity.

Blood samples are collected before the second course of treatment for translational

Patients complete questionnaires on side effects, quality of life, and chemotherapy-induced
peripheral neuropathy periodically.

After completion of study treatment, patients are followed up at 3, 6, 12, and 18 months.

Inclusion Criteria


- 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

- Patients receiving bevacizumab or cetuximab in combination with FOLFOX as part
of a clinical trial or clinical practice are eligible


- 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

- 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


- 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

Type of Study:


Study Design:

Allocation: Randomized, Masking: Double-Blind, Primary Purpose: Supportive Care

Outcome Measure:

Oxaliplatin-induced sensory neuropathy as repeatedly measured by the EORTC QLQ-CIPN20 sensory subscale during chemotherapy

Safety Issue:


Principal Investigator

Charles L. Loprinzi, MD

Investigator Role:

Study Chair

Investigator Affiliation:

North Central Cancer Treatment Group


United States: Federal Government

Study ID:




Start Date:

June 2010

Completion Date:

Related Keywords:

  • Chemotherapeutic Agent Toxicity
  • Colorectal Cancer
  • Neuropathy
  • Neurotoxicity
  • 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
  • Colonic Neoplasms
  • Rectal Neoplasms
  • Colorectal Neoplasms
  • Neurotoxicity Syndromes



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Illinois CancerCare - Peru Peru, Illinois  61354
Illinois CancerCare - Princeton Princeton, Illinois  61356
Illinois CancerCare - Spring Valley Spring Valley, Illinois  61362
York Hospital's Oncology Treatment Center York, Maine  03909
Caritas St. Elizabeth's Medical Center Brighton, Massachusetts  02135-2997
New Hampshire Oncology - Hematology, PA at Payson Center for Cancer Care Concord, New Hampshire  03301
Center for Cancer Care at Exeter Hospital Exeter, New Hampshire  03833
New Hampshire Oncology - Hematology, PA - Hooksett Hooksett, New Hampshire  03106
Trinity CancerCare Center Minot, North Dakota  58701
United States Air Force Medical Center - Wright-Patterson Wright-Patterson AFB, Ohio  45433-5529
Cancer Center of Paoli Memorial Hospital Paoli, Pennsylvania  19301-1792
CCOP - Main Line Health Wynnewood, Pennsylvania  19096
AnMed Cancer Center Anderson, South Carolina  29621
Franciscan Skemp Healthcare - La Crosse Campus La Crosse, Wisconsin  54601
Fountain Valley, California  92708
St. Anthony's Cancer Center St. Louis, Missouri  63128
Medcenter One Hospital Cancer Care Center Bismarck, North Dakota  58501
St. Alexius Medical Center Cancer Center Bismarck, North Dakota  58502
Hematology-Oncology Associates of Fredericksburg, Incorporated Fredericksburg, Virginia  22401
Oncology Center at St. Joseph Hospital Nashua, New Hampshire  03060
St. Mary's Regional Cancer Center at St. Mary's Medical Center Huntington, West Virginia  25702
CaroMont Cancer Center at Gaston Memorial Hospital Gastonia, North Carolina  28053
Immanuel St. Joseph's Mankato, Minnesota  56002
Fitzpatrick Cancer Center at Champlain Valley Physicians Hospital Medical Center Plattsburgh, New York  12901
Mercy Regional Cancer Center Janesville, Wisconsin  53547
Columbia Saint Mary's Hospital - Ozaukee Mequon, Wisconsin  53097
Columbia-Saint Mary's Cancer Care Center Milwaukee, Wisconsin  53211
Cancer Centers of the Carolinas - Easley Easley, South Carolina  29640
Self Regional Cancer Center at Self Regional Medical Center Greenwood, South Carolina  29646
Shore Regional Cancer Center at Memorial Hospital - Easton Easton, Maryland  21601
Kings County Hospital Center Brooklyn, New York  11203
Ravenel Oncology Center at Memorial Hospital of Martinsville and Henry County Martinsville, Virginia  24115
Central Wisconsin Cancer Program at Agnesian HealthCare Fond du Lac, Wisconsin  54935
Clarian Arnett Cancer Care Lafayette, Indiana  47904
Bassett Healthcare Regional Cancer Program at Mary Imogene Bassett Hospital Cooperstown, New York  13326
CCOP - Kansas City Prairie Village, Kansas  66208
Norwalk Hospital Norwalk, Connecticut  06856
Langlade Memorial Hospital Antigo, Wisconsin  54409
Piedmont Fayette Hospital Fayetteville, Georgia  30214
Southeast Cancer Center Cape Girardeau, Missouri  63703
Goldschmidt Cancer Center Jefferson City, Missouri  65109
Comprehensive Cancer Care, PC Saint Louis, Missouri  63141
Riverview UW Cancer Center at Riverview Hospital Wisconsin Rapids, Wisconsin  54494
St. Nicholas Hospital Sheboygan, Wisconsin  53081
North Broward Medical Center Dearfield Beach, Florida  33064-3596
Pacific Medical Center Seattle, Washington  98104
Overlake Cancer Center at Overlake Hospital Medical Center Bellevue, Washington  98004
Trinitas Comprehensive Cancer Center at Trinitas Hospital Elizabeth, New Jersey  07207
Providence Regional Cancer Partnership Everett, Washington  98201
Cancer Center of Kansas, PA - McPherson McPherson, Kansas  67460
Carolina Blood and Cancer Care Associates, PA Lancaster, South Carolina  29720
Carolina Blood and Cancer Care Rock Hill, South Carolina  29732
Kaiser Permanente Medical Center - Vacaville Vacaville, California  95688
St. Joseph Regional Medical Center Lewiston, Idaho  83501
Mercy Cancer Center - West Lakes Clive, Iowa  50325
Methodist West Hospital West Des Moines, Iowa  50266-7700
Kaiser Permanente Fresno Medical Center Fresno, California  93720