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Calcium/Magnesium to Prevent Oxaliplatin-Induced Neurotoxicity in Colorectal Cancer
NCT00316914Phase 3
Key facts
- Status
- Completed
- Start
- Jan 2006
- Primary completion
- Jan 2008
- Countries
- 1
- Sponsor
- Cancer and Leukemia Group B
- Modality
- Small Molecules
- Conditions
- neurotoxicity
01
Overview
Phase 3, randomised, double-blind trial of calcium gluconate and magnesium sulfate in neurotoxicity (2 arms), sponsored by Cancer and Leukemia Group B. Primary endpoint: Percentage of Patients With Oxaliplatin-induced Grade 2+ Chronic Neuropathic Adverse Event at 127 days. Started Jan 2006; status: completed.
02
Design
2 arms- Study design
- RandomizedDouble-blind
Ca/Mg
Calcium gluconate and magnesium sulfate IV over 30 minutes immediately before and after each oxaliplatin administration.
Placebo
Placebo IV over 30 minutes immediately before and after each oxaliplatin administration.
03
Who it enrols
Patients with completely resected stage II-IV colorectal adenocarcinoma scheduled for 6 months of adjuvant FOLFOX, with adequate organ function and no pre-existing peripheral neuropathy or prior neurotoxic chemotherapy.
04
Endpoints
Primary
Percentage of Patients With Oxaliplatin-induced Grade 2+ Chronic Neuropathic Adverse Event
Secondary
Time to Onset of Grade 2+ Chronic Neurotoxicity
Time to Onset of Grade 3+ Chronic Neurotoxicity
Average Duration of Chronic Neuropathic Toxicity
Percentage of Patients Discontinuing Therapy for Chronic Neurotoxicity
Average Cumulative Oxaliplatin Dose
Average Duration of Oxaliplatin-containing Treatment
Percentage of Patients With Acute Neuropathic Adverse Event
Incidence of Calcium Magnesium (CaMg)-Induced Adverse Event
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