The Use of Calcium and Magnesium for Prevention of Ixabepilone Induced Peripheral Neuropathy: A Phase III Double-Blind Placebo Controlled Study
18 Years
N/A
Both
Stage IV Breast Cancer, Recurrent Breast Cancer
Trial Information
The Use of Calcium and Magnesium for Prevention of Ixabepilone Induced Peripheral Neuropathy: A Phase III Double-Blind Placebo Controlled Study
PRIMARY OBJECTIVES: I. To compare ixabepilone-induced peripheral neuropathy (sensory) as
measured by EORTC QLQ-CIPN20 sensory subscale between CaMg and placebo arms. SECONDARY
OBJECTIVES: I. To compare the incidence of CTCAE measured grade 2+ and/or grade 3+
peripheral neuropathy between CaMg and placebo arms. II. To compare the times to onset of
CTCAE measured grade 2+ and/or grade 3+ peripheral neuropathy between CaMg and placebo arms.
III. To compare the proportion of patients requiring ixabepilone dose reductions and/or
stopping ixabepilone secondary to peripheral neuropathy (sensory) between CaMg and placebo
arms. IV. To assess the toxicity of CaMg in this situation. V. To document the incidence and
severity of the acute pain syndrome (APS, commonly known as arthralgias/myalgias) induced by
ixabepilone. VI. To evaluate whether CaMg will decrease the acute pain syndrome (APS). VII.
To evaluate the incidence and characteristics of, and change in, ixabepilone-APS over
several cycles. VIII. To evaluate the association between the ixabepilone-APS and eventual
chemotherapy-induced neuropathy. OUTLINE: Patients are randomized to 1 of 2 treatment arms.
ARM I: Patients receive calcium gluconate and magnesium sulfate IV over 30 minutes
immediately before and after ixabepilone treatment. ARM II: Patients receive calcium
placebo IV over 30 minutes immediately before and after ixabepilone treatment.
Inclusion Criteria
Inclusion:
- Scheduled to undergo cancer treatment for metastatic breast cancer (weekly or once
every three weeks) with ixabepilone with no prior exposure to ixabepilone and no more
than 2 prior chemotherapy regimens for metastatic disease
- Serum calcium =< 1.2 x UNL
- Serum magnesium =< UNL
- Serum creatinine =< 1.5 x UNL
- Ability to sign informed consent and understand the nature of a placebo-controlled
trial
- ECOG Performance Status (PS) of 0, 1, or 2 (this form is on the MCCRC website
https:/mccrc.mayo.edu/mccrc/forms/NonProtocolSpecificForms/)
- Ability to complete questionnaire(s) by themselves or with assistance - Life
expectancy >= 4 months
- Presence of a central line placed for administration of calcium and magnesium
- Please contact study investigator and/or consult protocol document for specific
details on laboratory criteria
Exclusion:
- Pre-existing history of peripheral neuropathy >= grade 2 (NCI CTCAE Active Version)
due to any cause (chemotherapy, diabetes, alcohol, toxin, hereditary, etc.)
- Concurrent treatment with anticonvulsants, tricyclic antidepressants, or other
neuropathic pain medications agents such as carbamazepine, phenytoin, valproic acid,
gabapentin, lamotrigine, topical lidocaine patch, capsaicin cream, etc., or any other
treatments specifically for prevention or treatment of neuropathy
- Other medical conditions, which in the opinion of the treating physician/allied
health professional would make this protocol unreasonably hazardous for the patient
- Any of the following: Pregnant women; Nursing women; Women of childbearing potential
(per physician judgment)
- Diagnosed diabetes requiring insulin or oral hypoglycemic medications -
Receiving digoxin or digitoxin
- History of heart block (any degree)
- Current treatment for arrhythmias
- Concurrent treatment with other neuropathic chemotherapy agents
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Supportive Care
Outcome Measure:
Comparison of chemotherapy-induced peripheral neuropathy between CaMg and placebo arms, as measured by the sensory subscale of EORTC QLQ-CIPN20
Outcome Time Frame:
During the first 18 weeks of ixabepilone-based therapy
Safety Issue:
No
Principal Investigator
Charles Loprinzi, M.D.
Investigator Role:
Principal Investigator
Investigator Affiliation:
Mayo Clinic
Authority:
United States: Institutional Review Board
Study ID:
RC08CC
NCT ID:
NCT00998738
Start Date:
November 2009
Completion Date:
Related Keywords:
- Stage IV Breast Cancer
- Recurrent Breast Cancer
- Breast Neoplasms
- Peripheral Nervous System Diseases
Name | Location |
|---|---|
| Mayo Clinic | Rochester, Minnesota 55905 |
