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Sponsors and Collaborators: |
North Central Cancer Treatment Group National Cancer Institute (NCI) |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00316914 |
RATIONALE: Calcium gluconate and magnesium sulfate may prevent or lessen neurotoxicity caused by oxaliplatin. It is not yet known whether calcium gluconate and magnesium sulfate are more effective than a placebo in preventing neurotoxicity caused by oxaliplatin in patients receiving combination chemotherapy.
PURPOSE: This randomized phase III trial is studying calcium gluconate and magnesium sulfate to see how well they work compared to a placebo in preventing neurotoxicity caused by oxaliplatin in patients receiving combination chemotherapy for stage II, stage III, or stage IV colorectal cancer that has been completely removed by surgery.
Condition | Intervention | Phase |
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Cancer-Related Problem/Condition Colorectal Cancer |
Drug: calcium gluconate Drug: magnesium sulfate Drug: placebo |
Phase III |
Study Type: | Interventional |
Study Design: | Supportive Care, Randomized, Double-Blind, Placebo Control |
Official Title: | A Phase III Randomized, Placebo-Controlled, Double-Blind Study of Intravenous Calcium/Magnesium to Prevent Oxaliplatin-Induced Sensory Neurotoxicity |
Estimated Enrollment: | 300 |
Study Start Date: | January 2006 |
Arms | Assigned Interventions |
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Arm I: Experimental
Patients receive calcium gluconate and magnesium sulfate IV over 30 minutes immediately before and after each oxaliplatin administration (once every 2 weeks) of their assigned chemotherapy regimen.
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Drug: calcium gluconate
Given IV
Drug: magnesium sulfate
Given IV
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Arm II: Placebo Comparator
Patients receive a placebo IV over 30 minutes immediately before and after each oxaliplatin administration (once every 2 weeks) of their assigned chemotherapy regimen.
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Drug: placebo
Given IV
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OBJECTIVES:
OUTLINE: This is a randomized, placebo-controlled, double-blind, multicenter study. Patients are stratified according to age (< 65 vs > 65), gender, and chemotherapy regimen (FOLFOX4 vs modified FOLFOX6). Patients are randomized to 1 of 2 treatment arms.
In both arms, treatment continues until chemotherapy is discontinued (approximately 6 months).
Patients complete quality of life questionnaires on day 1, a symptom experience diary on days 2-5 of their chemotherapy regimen, and questionnaires at 1 and 3 months after completion of study treatment.
Blood samples are collected at baseline and tested for the GSTP1 gene.
After completion of study treatment, patients are followed for at least 3 months.
PROJECTED ACCRUAL: A total of 300 patients will be accrued for this study.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically confirmed adenocarcinoma of the colon or rectum
Scheduled to receive 6 months of adjuvant treatment with either of the following FOLFOX chemotherapy regimens:
PATIENT CHARACTERISTICS:
PRIOR CONCURRENT THERAPY:
United States, Georgia | |
MBCCOP - Medical College of Georgia Cancer Center | |
Augusta, Georgia, United States, 30912 | |
United States, Iowa | |
CCOP - Iowa Oncology Research Association | |
Des Moines, Iowa, United States, 50309 | |
John Stoddard Cancer Center at Iowa Lutheran Hospital | |
Des Moines, Iowa, United States, 50316 | |
Mercy Cancer Center at Mercy Medical Center - Des Moines | |
Des Moines, Iowa, United States, 50314 | |
Medical Oncology and Hematology Associates at John Stoddard Cancer Center | |
Des Moines, Iowa, United States, 50309 | |
Medical Oncology and Hematology Associates at Mercy Cancer Center | |
Des Moines, Iowa, United States, 50314 | |
John Stoddard Cancer Center at Iowa Methodist Medical Center | |
Des Moines, Iowa, United States, 50309 | |
Mercy Capitol Hospital | |
Des Moines, Iowa, United States, 50307 | |
United States, North Dakota | |
Bismarck Cancer Center | |
Bismarck, North Dakota, United States, 58501 | |
Medcenter One Hospital Cancer Care Center | |
Bismarck, North Dakota, United States, 58501 | |
Mid Dakota Clinic, PC | |
Bismarck, North Dakota, United States, 58501 | |
United States, South Dakota | |
Sanford Cancer Center at Sanford USD Medical Center | |
Sioux Falls, South Dakota, United States, 57117-5039 | |
Medical X-Ray Center, PC | |
Sioux Falls, South Dakota, United States, 57105 | |
Avera Cancer Institute | |
Sioux Falls, South Dakota, United States, 57105 |
Investigator: | Charles L. Loprinzi, MD | Mayo Clinic |
Investigator: | Daniel Nikcevich, MD, PhD | Duluth Clinic Cancer Center - Duluth |
Study Chair: | Axel Grothey, MD | Mayo Clinic |
Investigator: | Steven R. Alberts, MD | Mayo Clinic |
Study ID Numbers: | CDR0000471238, NCCTG-N04C7 |
Study First Received: | April 19, 2006 |
Last Updated: | January 7, 2009 |
ClinicalTrials.gov Identifier: | NCT00316914 |
Health Authority: | United States: Federal Government |
neurotoxicity stage II colon cancer stage III colon cancer adenocarcinoma of the colon stage II rectal cancer |
stage III rectal cancer stage IV rectal cancer stage IV colon cancer adenocarcinoma of the rectum |
Digestive System Neoplasms Neurotoxicity Syndromes Rectal Neoplasms Gastrointestinal Diseases Magnesium Sulfate Neurotoxicity syndromes Colonic Diseases Poisoning Disorders of Environmental Origin Intestinal Diseases |
Rectal Diseases Intestinal Neoplasms Rectal neoplasm Calcium, Dietary Oxaliplatin Digestive System Diseases Gastrointestinal Neoplasms Adenocarcinoma Rectal cancer Colorectal Neoplasms |
Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Nervous System Diseases Physiological Effects of Drugs Calcium Channel Blockers Anesthetics Central Nervous System Depressants Reproductive Control Agents Cardiovascular Agents Pharmacologic Actions Membrane Transport Modulators |
Neoplasms Neoplasms by Site Tocolytic Agents Sensory System Agents Therapeutic Uses Analgesics Peripheral Nervous System Agents Anti-Arrhythmia Agents Central Nervous System Agents Anticonvulsants |