NCT01099449

Calcium Gluconate and Magnesium Sulfate in Preventing Neurotoxicity in Patients With Colon Cancer or Rectal Cancer Receiving Oxaliplatin-Based Combination Chemotherapy

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 362 (actual)
• Sponsor: Alliance for Clinical Trials in Oncology · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

OBJECTIVES: Primary * 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. Secondary * 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. Tertiary * 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 research. 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.

Conditions

• Chemotherapeutic Agent Toxicity
• Colorectal Cancer
• Neuropathy
• Neurotoxicity

Interventions

Type	Name	Description
DRUG	calcium gluconate	Given IV
DRUG	magnesium sulfate	Given IV
OTHER	placebo	Given IV
DRUG	oxaliplatin

Timeline

• Start date: 2010-06-01
• Primary completion: 2012-12-01
• Completion: 2013-03-01
• First posted: 2010-04-07
• Last updated: 2022-11-03
• Results posted: 2019-05-23

Locations

405 sites across 2 countries: United States, Puerto Rico