drugset / Trial / NCT01099449
Calcium Gluconate and Magnesium Sulfate in Preventing Neurotoxicity in Patients With Colon Cancer or Rectal Cancer Receiving Oxaliplatin-Based Combination Chemotherapy
Phase 3
Completed
362 enrolled
Alliance for Clinical Trials in Oncology
National Cancer Institute (NCI) · collab
RandomizedParallel-groupDouble-blindSupportive care
Summary
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.
Timeline
- Start
- 2010-06
- Primary completion
- 2012-12
- Completion
- 2013-03
Publications
- Hertz DL, Dockter TJ, Satele DV, Loprinzi CL, Le-Rademacher J. Neuropathy severity at the time of oxaliplatin treatment alteration in patients with colon cancer (Alliance A151912). Support Care Cancer. 2021 Dec;29(12):7855-7863. doi: 10.1007/s00520-021-06371-x. Epub 2021 Jun 27.
- Loprinzi CL, Qin R, Dakhil SR, Fehrenbacher L, Flynn KA, Atherton P, Seisler D, Qamar R, Lewis GC, Grothey A. Phase III randomized, placebo-controlled, double-blind study of intravenous calcium and magnesium to prevent oxaliplatin-induced sensory neurotoxicity (N08CB/Alliance). J Clin Oncol. 2014 Apr 1;32(10):997-1005. doi: 10.1200/JCO.2013.52.0536. Epub 2013 Dec 2.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Magnesium Sulfate | Other / unclassified | — | Intravenous |
| Subject | calcium gluconate | Small molecule | — | Intravenous |
| Background | Oxaliplatin | Small molecule | — | Intravenous |