Calcium Gluconate and Magnesium Sulfate in Preventing Neurotoxicity in Patients With Colon Cancer or Rectal Cancer Receiving Oxaliplatin-Based Combination Chemotherapy
Chemotherapeutic Agent Toxicity, Colorectal Cancer, Neuropathy
About this trial
This is an interventional supportive care trial for Chemotherapeutic Agent Toxicity focused on measuring 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
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
Sites / Locations
- Fairbanks Cancer Treatment Center at Fairbanks Memorial Hospital
- Kaiser Permanente - Deer Valley
- North Bay Cancer Center
- Kaiser Permanente - Fremont
- Kaiser Permanente Fresno Medical Center
- Kaiser Permanente Medical Center - Hayward
- Kaiser Permanente Medical Center - Oakland
- Kaiser Permanente Medical Center - Redwood City
- Kaiser Permanente Medical Center - Richmond
- Kaiser Permanente Medical Center - Roseville
- South Sacramento Kaiser-Permanente Medical Center
- Kaiser Permanente Medical Center - Sacramento
- Kaiser Permanente Medical Center - San Francisco Geary Campus
- Kaiser Permanente Medical Center - Santa Teresa
- Kaiser Foundation Hospital - San Rafael
- Kaiser Permanente Medical Center - Santa Clara Kiely Campus
- Kaiser Permanente Medical Center - Santa Rosa
- Kaiser Permanente Medical Center - South San Francisco
- Kaiser Permanente Medical Facility - Stockton
- Kaiser Permanente Medical Center - Vacaville
- Kaiser Permanente Medical Center - Vallejo
- Kaiser Permanente Medical Center - Walnut Creek
- Aurora Presbyterian Hospital
- Boulder Community Hospital
- Penrose Cancer Center at Penrose Hospital
- St. Anthony Central Hospital
- Kaiser Permanente - Denver
- Porter Adventist Hospital
- Presbyterian - St. Luke's Medical Center
- St. Joseph Hospital
- Rose Medical Center
- CCOP - Colorado Cancer Research Program
- Swedish Medical Center
- St. Mary's Regional Cancer Center at St. Mary's Hospital and Medical Center
- North Colorado Medical Center
- Kaiser Permanente - Lafayette
- Sky Ridge Medical Center
- Hope Cancer Care Center at Longmont United Hospital
- McKee Medical Center
- St. Mary - Corwin Regional Medical Center
- North Suburban Medical Center
- Exempla Lutheran Medical Center
- Saint Francis/Mount Sinai Regional Cancer Center at Saint Francis Hospital and Medical Center
- Norwalk Hospital
- Tunnell Cancer Center at Beebe Medical Center
- CCOP - Christiana Care Health Services
- North Broward Medical Center
- Michael and Dianne Bienes Comprehensive Cancer Center at Holy Cross Hospital
- Broward General Medical Center Cancer Center
- Ella Milbank Foshay Cancer Center at Jupiter Medical Center
- CCOP - Mount Sinai Medical Center
- Florida Hospital Cancer Institute at Florida Hospital Orlando
- Phoebe Cancer Center at Phoebe Putney Memorial Hospital
- Piedmont Hospital
- Northside Hospital Cancer Center
- Saint Joseph's Hospital of Atlanta
- CCOP - Atlanta Regional
- WellStar Cobb Hospital
- John B. Amos Cancer Center
- Charles B. Eberhart Cancer Center at DeKalb Medical Center
- Veterans Affairs Medical Center - Atlanta (Decatur)
- Piedmont Fayette Hospital
- Gwinnett Medical Center
- Kennestone Cancer Center at Wellstar Kennestone Hospital
- Southern Regional Medical Center
- Harbin Clinic Cancer Center - Medical Oncology
- Curtis and Elizabeth Anderson Cancer Institute at Memorial Health University Medical Center
- Nancy N. and J. C. Lewis Cancer and Research Pavilion at St. Joseph's/Candler
- Kapiolani Medical Center at Pali Momi
- Cancer Research Center of Hawaii
- OnCare Hawaii, Incorporated - Lusitana
- Queen's Cancer Institute at Queen's Medical Center
- Straub Clinic and Hospital, Incorporated
- Hawaii Medical Center - East
- OnCare Hawaii, Incorporated - Kuakini
- Kaiser Permanente - Moanalua Medical Center and Clinic
- Kapiolani Medical Center for Women and Children
- Tripler Army Medical Center
- Maui Memorial Medical Center
- Pacific Cancer Institute - Maui
- Saint Alphonsus Cancer Care Center at Saint Alphonsus Regional Medical Center
- St. Joseph Regional Medical Center
- Rush-Copley Cancer Care Center
- Illinois CancerCare - Bloomington
- Graham Hospital
- Illinois CancerCare - Canton
- Illinois CancerCare - Carthage
- Memorial Hospital
- University of Illinois Cancer Center
- Louis A. Weiss Memorial Hospital
- Decatur Memorial Hospital Cancer Care Institute
- Eureka Community Hospital
- Illinois CancerCare - Eureka
- Galesburg Clinic, PC
- Illinois CancerCare - Galesburg
- Illinois CancerCare - Havana
- Mason District Hospital
- Illinois CancerCare - Kewanee Clinic
- Illinois CancerCare - Macomb
- McDonough District Hospital
- Trinity Cancer Center at Trinity Medical Center - 7th Street Campus
- Illinois CancerCare - Monmouth
- BroMenn Regional Medical Center
- Community Cancer Center
- Illinois CancerCare - Community Cancer Center
- Community Hospital of Ottawa
- Oncology Hematology Associates of Central Illinois, PC - Ottawa
- Cancer Treatment Center at Pekin Hospital
- Illinois CancerCare - Pekin
- Proctor Hospital
- CCOP - Illinois Oncology Research Association
- Oncology Hematology Associates of Central Illinois, PC - Peoria
- Methodist Medical Center of Illinois
- Illinois CancerCare - Peru
- Illinois Valley Community Hospital
- Illinois CancerCare - Princeton
- Perry Memorial Hospital
- West Suburban Center for Cancer Care
- Illinois CancerCare - Spring Valley
- Regional Cancer Center at Memorial Medical Center
- CCOP - Carle Cancer Center
- St. Francis Hospital and Health Centers - Beech Grove Campus
- Elkhart Clinic, LLC
- Michiana Hematology-Oncology, PC - Elkhart
- Elkhart General Hospital
- Howard Community Hospital
- Center for Cancer Therapy at LaPorte Hospital and Health Services
- Clarian Arnett Cancer Care
- Saint Anthony Memorial Health Centers
- Michiana Hematology-Oncology, PC - South Bend
- Saint Joseph Regional Medical Center
- Michiana Hematology Oncology PC - Plymouth
- Reid Hospital & Health Care Services
- CCOP - Northern Indiana CR Consortium
- Memorial Hospital of South Bend
- Michiana Hematology Oncology PC - La Porte
- Cedar Rapids Oncology Associates
- Mercy Regional Cancer Center at Mercy Medical Center
- Medical Oncology and Hematology Associates - West Des Moines
- Mercy Cancer Center - West Lakes
- CCOP - Iowa Oncology Research Association
- John Stoddard Cancer Center at Iowa Methodist Medical Center
- Medical Oncology and Hematology Associates at John Stoddard Cancer Center
- Medical Oncology and Hematology Associates at Mercy Cancer Center
- Mercy Cancer Center at Mercy Medical Center - Des Moines
- John Stoddard Cancer Center at Iowa Lutheran Hospital
- Siouxland Hematology-Oncology Associates, LLP
- Mercy Medical Center - Sioux City
- St. Luke's Regional Medical Center
- Covenant Cancer Treatment Center
- Methodist West Hospital
- Cancer Center of Kansas, PA - Chanute
- Cancer Center of Kansas, PA - Dodge City
- Cancer Center of Kansas, PA - El Dorado
- Cancer Center of Kansas - Fort Scott
- Cancer Center of Kansas-Independence
- Cancer Center of Kansas, PA - Kingman
- Lawrence Memorial Hospital
- Cancer Center of Kansas, PA - Liberal
- Cancer Center of Kansas, PA - McPherson
- Cancer Center of Kansas, PA - Newton
- Menorah Medical Center
- Saint Luke's Hospital - South
- Cancer Center of Kansas, PA - Parsons
- CCOP - Kansas City
- Cancer Center of Kansas, PA - Pratt
- Cancer Center of Kansas, PA - Salina
- Cancer Center of Kansas, PA - Wellington
- Associates in Womens Health, PA - North Review
- Cancer Center of Kansas, PA - Medical Arts Tower
- Cancer Center of Kansas, PA - Wichita
- CCOP - Wichita
- Via Christi Cancer Center at Via Christi Regional Medical Center
- Cancer Center of Kansas, PA - Winfield
- MBCCOP - LSU Health Sciences Center
- Medical Center of Louisiana - New Orleans
- York Hospital's Oncology Treatment Center
- Shore Regional Cancer Center at Memorial Hospital - Easton
- Union Hospital of Cecil County
- Sturdy Memorial Hospital
- Boston University Cancer Research Center
- Caritas St. Elizabeth's Medical Center
- Hickman Cancer Center at Bixby Medical Center
- Saint Joseph Mercy Cancer Center
- CCOP - Michigan Cancer Research Consortium
- Oakwood Cancer Center at Oakwood Hospital and Medical Center
- Green Bay Oncology, Limited - Escanaba
- Genesys Hurley Cancer Institute
- Hurley Medical Center
- Genesys Regional Medical Center
- Van Elslander Cancer Center at St. John Hospital and Medical Center
- Dickinson County Healthcare System
- Foote Memorial Hospital
- Borgess Medical Center
- West Michigan Cancer Center
- Bronson Methodist Hospital
- Sparrow Regional Cancer Center
- St. Mary Mercy Hospital
- Community Cancer Center of Monroe
- Mercy Memorial Hospital - Monroe
- Michiana Hematology Oncology PC - Niles
- St. Joseph Mercy Oakland
- Mercy Regional Cancer Center at Mercy Hospital
- William Beaumont Hospital - Royal Oak Campus
- Seton Cancer Institute at Saint Mary's - Saginaw
- Lakeland Regional Cancer Care Center - St. Joseph
- Lakeside Cancer Specialists, PLLC
- St. John Macomb Hospital
- Duluth Clinic Cancer Center - Duluth
- CCOP - Duluth
- Miller - Dwan Medical Center
- Immanuel St. Joseph's
- Hennepin County Medical Center - Minneapolis
- Mayo Clinic Cancer Center
- Regional Cancer Center at Singing River Hospital
- Southeast Cancer Center
- Saint Luke's Hospital
- Goldschmidt Cancer Center
- Saint Luke's Cancer Institute at Saint Luke's Hospital
- North Kansas City Hospital
- Parvin Radiation Oncology
- Heartland Hematology Oncology Associates, Incorporated
- Research Medical Center
- Saint Luke's East - Lee's Summit
- Heartland Regional Medical Center
- Saint Joseph Oncology, Incorporated
- Saint Louis University Cancer Center
- St. Anthony's Cancer Center
- Missouri Baptist Cancer Center
- Comprehensive Cancer Care, PC
- CCOP - Montana Cancer Consortium
- St. Vincent Healthcare Cancer Care Services
- Hematology-Oncology Centers of the Northern Rockies - Billings
- Billings Clinic - Downtown
- Bozeman Deaconess Cancer Center
- St. James Healthcare Cancer Care
- Big Sky Oncology
- Great Falls Clinic - Main Facility
- Sletten Cancer Institute at Benefis Healthcare
- Northern Montana Hospital
- St. Peter's Hospital
- Glacier Oncology, PLLC
- Kalispell Medical Oncology at KRMC
- Kalispell Regional Medical Center
- Montana Cancer Specialists at Montana Cancer Center
- Montana Cancer Center at St. Patrick Hospital and Health Sciences Center
- Cancer Resource Center - Lincoln
- CCOP - Missouri Valley Cancer Consortium
- Immanuel Medical Center
- Alegant Health Cancer Center at Bergan Mercy Medical Center
- Creighton University Medical Center
- University Medical Center of Southern Nevada
- CCOP - Nevada Cancer Research Foundation
- New Hampshire Oncology - Hematology, PA at Payson Center for Cancer Care
- Center for Cancer Care at Exeter Hospital
- New Hampshire Oncology - Hematology, PA - Hooksett
- Lakes Region General Hospital
- Oncology Center at St. Joseph Hospital
- Trinitas Comprehensive Cancer Center at Trinitas Hospital
- Newark Beth Israel Medical Center
- Cancer Institute of New Jersey at Cooper - Voorhees
- Kings County Hospital Center
- SUNY Downstate Medical Center
- Veterans Affairs Medical Center - Brooklyn
- Bassett Healthcare Regional Cancer Program at Mary Imogene Bassett Hospital
- CCOP - Hematology-Oncology Associates of Central New York
- Monter Cancer Center of the North Shore-LIJ Health System
- CCOP - North Shore University Hospital
- Don Monti Comprehensive Cancer Center at North Shore University Hospital
- Long Island Jewish Medical Center
- Fitzpatrick Cancer Center at Champlain Valley Physicians Hospital Medical Center
- Randolph Hospital
- CaroMont Cancer Center at Gaston Memorial Hospital
- Wayne Memorial Hospital, Incorporated
- Moses Cone Regional Cancer Center at Wesley Long Community Hospital
- Pardee Memorial Hospital
- FirstHealth Moore Regional Community Hospital Comprehensive Cancer Center
- Annie Penn Cancer Center
- Rutherford Hospital
- Iredell Memorial Hospital
- Bismarck Cancer Center
- Medcenter One Hospital Cancer Care Center
- Mid Dakota Clinic, PC
- St. Alexius Medical Center Cancer Center
- Altru Cancer Center at Altru Hospital
- Trinity CancerCare Center
- McDowell Cancer Center at Akron General Medical Center
- Wood County Oncology Center
- MetroHealth Cancer Care Center at MetroHealth Medical Center
- Grandview Hospital
- Good Samaritan Hospital
- David L. Rike Cancer Center at Miami Valley Hospital
- Samaritan North Cancer Care Center
- CCOP - Dayton
- Community Cancer Center
- Hematology Oncology Center
- Blanchard Valley Medical Associates
- Middletown Regional Hospital
- Wayne Hospital
- Charles F. Kettering Memorial Hospital
- St. Rita's Medical Center
- Lima Memorial Hospital
- Northwest Ohio Oncology Center
- St. Charles Mercy Hospital
- Toledo Clinic - Oregon
- North Coast Cancer Care, Incorporated
- Flower Hospital Cancer Center
- Mercy Hospital of Tiffin
- Toledo Hospital
- St. Vincent Mercy Medical Center
- Medical University of Ohio Cancer Center
- CCOP - Toledo Community Hospital
- St. Anne Mercy Hospital
- Toledo Clinic, Incorporated - Main Clinic
- UVMC Cancer Care Center at Upper Valley Medical Center
- Fulton County Health Center
- United States Air Force Medical Center - Wright-Patterson
- Ruth G. McMillan Cancer Center at Greene Memorial Hospital
- Oklahoma University Cancer Institute
- LaFortune Cancer Center at St. John Medical Center
- Natalie Warren Bryant Cancer Center at St. Francis Hospital
- Kaiser Permanente Health Care - Portland
- Morgan Cancer Center at Lehigh Valley Hospital - Cedar Crest
- Bryn Mawr Hospital
- Geisinger Cancer Institute at Geisinger Health
- Geisinger Hazleton Cancer Center
- Cancer Center of Paoli Memorial Hospital
- Geisinger Medical Group - Scenery Park
- Frank M. and Dorothea Henry Cancer Center at Geisinger Wyoming Valley Medical Center
- CCOP - Main Line Health
- Lankenau Cancer Center at Lankenau Hospital
- Kent County Memorial Hospital
- AnMed Cancer Center
- Roper St. Francis Cancer Center at Roper Hospital
- Cancer Centers of the Carolinas - Easley
- McLeod Regional Medical Center
- Bon Secours St. Francis Health System
- Cancer Centers of the Carolinas - Faris Road
- Cancer Centers of the Carolinas - Grove Commons
- Greenville Hospital Cancer Center
- Self Regional Cancer Center at Self Regional Medical Center
- Cancer Centers of the Carolinas - Greer Medical Oncology
- Carolina Blood and Cancer Care Associates, PA
- Carolina Blood and Cancer Care
- Cancer Centers of the Carolinas - Seneca
- CCOP - Upstate Carolina
- Gibbs Regional Cancer Center at Spartanburg Regional Medical Center
- Cancer Centers of the Carolinas - Spartanburg
- Rapid City Regional Hospital
- Christine LaGuardia Phillips Cancer Center at Wellmont Holston Valley Medical Center
- Fredericksburg Oncology, Incorporated
- Hematology-Oncology Associates of Fredericksburg, Incorporated
- Ravenel Oncology Center at Memorial Hospital of Martinsville and Henry County
- Southwest Virginia Regional Cancer Center at Wellmonth Health
- Overlake Cancer Center at Overlake Hospital Medical Center
- St. Joseph Cancer Center
- Providence Centralia Hospital
- Providence Regional Cancer Partnership
- St. Francis Hospital
- Cascade Cancer Center at Evergreen Hospital Medical Center
- Providence St. Peter Hospital Regional Cancer Center
- Good Samaritan Cancer Center
- CCOP - Virginia Mason Research Center
- Virginia Mason Medical Center
- Pacific Medical Center
- Franciscan Cancer Center at St. Joseph Medical Center
- Allenmore Hospital
- CCOP - Northwest
- MultiCare Regional Cancer Center at Tacoma General Hospital
- St. Clare Hospital
- Edwards Comprehensive Cancer Center at Cabell Huntington Hospital
- St. Mary's Regional Cancer Center at St. Mary's Medical Center
- Langlade Memorial Hospital
- Fox Valley Hematology and Oncology - East Grant Street
- Marshfield Clinic - Chippewa Center
- Marshfield Clinic Cancer Care at Regional Cancer Center
- Central Wisconsin Cancer Program at Agnesian HealthCare
- Green Bay Oncology, Limited at St. Vincent Hospital Regional Cancer Center
- Green Bay Oncology, Limited at St. Mary's Hospital
- St. Mary's Hospital Medical Center - Green Bay
- St. Vincent Hospital Regional Cancer Center
- Mercy Regional Cancer Center
- Franciscan Skemp Healthcare - La Crosse Campus
- Gundersen Lutheran Center for Cancer and Blood
- Holy Family Memorial Medical Center Cancer Care Center
- Bay Area Cancer Care Center at Bay Area Medical Center
- Marshfield Clinic - Marshfield Center
- Columbia Saint Mary's Hospital - Ozaukee
- Columbia-Saint Mary's Cancer Care Center
- Marshfield Clinic - Lakeland Center
- Green Bay Oncology, Limited - Oconto Falls
- All Saints Cancer Center at Wheaton Franciscan Healthcare
- Ministry Medical Group at Saint Mary's Hospital
- St. Nicholas Hospital
- Marshfield Clinic at Saint Michael's Hospital
- Green Bay Oncology, Limited - Sturgeon Bay
- University of Wisconcin Cancer Center at Aspirus Wausau Hospital
- Oncology Alliance, SC - Milwaukee - West
- Marshfield Clinic - Weston Center
- Riverview UW Cancer Center at Riverview Hospital
- Welch Cancer Center at Sheridan Memorial Hospital
- San Juan City Hospital
Arms of the Study
Arm 1
Arm 2
Arm 3
Experimental
Placebo Comparator
Experimental
Arm I
Arm II
Arm III
Patients receive calcium gluconate and magnesium sulfate IV over 30 minutes immediately before and after oxaliplatin administration (part of FOLFOX chemotherapy comprising leucovorin calcium, fluorouracil, and oxaliplatin).
Patients receive placebo IV over 30 minutes immediately before and after oxaliplatin administration (part of FOLFOX chemotherapy).
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).