Phase 3
N=102
Calcium Gluconate and Magnesium Sulfate 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
Colorectal Cancer · Neurotoxicity
Bottom Line
View on ClinicalTrials.gov: NCT00316914 ↗Enrolled (actual)
102
Serious AEs
2.9%
Results posted
Mar 2013
Primary outcome: Primary: Percentage of Patients With Oxaliplatin-induced Grade 2+ Chronic Neuropathic Adverse Event — 22; 41 Percentage of participants — p=0.038
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- calcium gluconate (Drug); magnesium sulfate (Drug); placebo (Other)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Alliance for Clinical Trials in Oncology
- Primary completion
- Jan 2008
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Patients With Oxaliplatin-induced Grade 2+ Chronic Neuropathic Adverse Event |
22; 41 | 0.038 sig |
| SECONDARY Time to Onset of Grade 2+ Chronic Neurotoxicity |
NA; 18.1 | 0.0503 |
| SECONDARY Time to Onset of Grade 3+ Chronic Neurotoxicity |
NA; NA | 0.4048 |
| SECONDARY Average Duration of Chronic Neuropathic Toxicity |
81; 72 | 0.6556 |
| SECONDARY Percentage of Patients Discontinuing Therapy for Chronic Neurotoxicity |
46; 55.8 | 0.3238 |
| SECONDARY Average Cumulative Oxaliplatin Dose |
— | — |
| SECONDARY Average Duration of Oxaliplatin-containing Treatment |
— | — |
| SECONDARY Percentage of Patients With Acute Neuropathic Adverse Event |
88; 90 | 0.7498 |
| SECONDARY Incidence of Calcium Magnesium (CaMg)-Induced Adverse Event |
2; 0; 2; 2; 4; 4 | — |
| SECONDARY Percentage of Patients Experiencing Impact on Activities of Daily Living (ADL) |
— | — |
| SECONDARY Change From Baseline in Fatigue Score at One Month |
1.0; -2.8; 3.1; -1.6; 0.0; -1.6 | 0.2340 |
| SECONDARY Change From Baseline in Quality of Life (QOL) at One Month |
0.0; -1.6; -2.5; 0.2; -2.0; 0.4 | 0.9364 |
Summary
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.
Eligibility Criteria
DISEASE CHARACTERISTICS:
- Histologically confirmed adenocarcinoma of the colon or rectum
- Stage II disease
- Stage III disease
- Stage IV disease (completely resected with no evidence of residual tumor)
- Must have undergone curative resection for stage II or III disease
- Scheduled to receive 6 months of adjuvant treatment with either of the following FOLFOX chemotherapy regimens:
- FOLFOX4, comprising leucovorin calcium, fluorouracil, and oxaliplatin (2-week course)
- Modified FOLFOX6, comprising high-dose leucovorin calcium, high-dose fluorouracil, and oxaliplatin (2-week course)
PATIENT CHARACTERISTICS:
- Absolute neutrophil count ≥ 1,500/mm^3
- Platelet count ≥ 100,000/mm^3
- Hemoglobin ≥ 10 g/dL
- WBC ≥ 3,000/mm^3
- Bilirubin ≤ 1.5 times upper limit of normal (ULN)
- Creatinine ≤ 1.5 times ULN
- Calcium normal
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception
- No pre-existing peripheral neuropathy of any grade
- No hypercalcemia
- No concurrent heart block or a history of heart block
- No other medical condition that, in the opinion of the treating physician, would make this protocol unreasonably hazardous for the patient
- No family history of a genetic/familial neuropathy
PRIOR CONCURRENT THERAPY:
- See Disease Characteristics
- No prior treatment with neurotoxic chemotherapy such as oxaliplatin, cisplatin, taxanes, or vinca alkaloids
- Concurrent use of bevacizumab or cetuximab in combination with FOLFOX as part of a clinical trial or clinical practice are allowed
- No concurrent digitalis medication
- No concurrent digoxin
- No concurrent treatment with anticonvulsants such as carbamazepine, phenytoin, or valproic acid
- No other concurrent neurotropic agents such as gabapentin
Data sourced from ClinicalTrials.gov (NCT00316914). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.