Calcium and Magnesium in Preventing Peripheral Neuropathy Caused by Ixabepilone in Patients With Breast Cancer

NCT00998738 | Terminated Phase 3 Results DMC

• 3 other identifiers: RC08CCNCI-2009-01229P30CA015083
• Study Type: interventional
• Target: 1
• Locations: 1 country
• Sites: 1

Brief Summary

This randomized phase III trial studies calcium and magnesium to see how well they work in preventing peripheral neuropathy caused by ixabepilone in patients with breast cancer. Giving calcium together with magnesium may stop or delay the development of peripheral neuropathy in patients with cancer who are receiving treatment with ixabepilone. It is not yet known whether calcium and magnesium are effective in preventing peripheral neuropathy caused by ixabepilone.

Conditions

Neuropathy; Pain; Recurrent Breast Carcinoma; Stage IV Breast Cancer

Outcome Measures

Primary Outcomes (1)

• Comparison of Chemotherapy-induced Peripheral Neuropathy Between Calcium With Magnesium (CaMg) and Placebo Arms, as Measured by the Sensory Subscale of EORTC QLQ-CIPN20

  European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire Chemotherapy-Induced Peripheral Neuropathy Module (EORTC QLQ-CIPN20) sensor subscale score was calculated following the standard scoring algorithm and was transformed to a 0 to 100 scale with 0=Low QOL and 100=Best QOL for data analysis.

  During the first 18 weeks of ixabepilone-based therapy

Secondary Outcomes (8)

• Percentage of Patients With Grade 2+ and/or Grade 3+ Neurotoxicity as Measured by NCI CTCAE Active Version Neuropathy Scale

  Up to 12 months from initiation of ixabepilone

• Time to Onset of Grade 2+ and/or Grade 3+ Neurotoxicity as Assessed by NCI CTCAE Active Version

  Up to 12 months from initiation of ixabepilone

• Proportion of Patients Undergoing Dose Reduction or Discontinuing Ixabepilone Secondary to Peripheral Neuropathy

  Up to 12 months from initiation of ixabepilone

• Average Cumulative Ixabepilone Dose

  Up to 12 months from initiation of ixabepilone

• Toxicity Profile of CaMg Per CTCAE Active Version

  Up to 12 months from initiation of ixabepilone

Study Arms (2)

Arm I (calcium gluconate, magnesium sulfate)

EXPERIMENTAL

Patients receive calcium gluconate and magnesium sulfate IV over 30 minutes immediately before and after each ixabepilone administration.

Drug: Calcium Gluconate; Drug: Magnesium Sulfate; Other: Quality-of-Life Assessment; Other: Questionnaire Administration; Drug: Ixabepilone

Arm II (placebo)

PLACEBO COMPARATOR

Patients receive placebo IV over 30 minutes immediately before and after each ixabepilone administration.

Other: Placebo; Other: Quality-of-Life Assessment; Other: Questionnaire Administration; Drug: Ixabepilone

Interventions

Calcium Gluconate DRUG

Given IV

Also known as: Calcium D-gluconate, Calglucon

Arm I (calcium gluconate, magnesium sulfate)

Magnesium Sulfate DRUG

Given IV

Also known as: Magnesium SO4, Magnesium Sulfate whiskers

Arm I (calcium gluconate, magnesium sulfate)

Placebo OTHER

Given IV

Also known as: placebo therapy, PLCB, sham therapy

Arm II (placebo)

Quality-of-Life Assessment OTHER

Ancillary studies

Also known as: Quality of Life Assessment

Arm I (calcium gluconate, magnesium sulfate); Arm II (placebo)

Questionnaire Administration OTHER

Ancillary studies

Arm I (calcium gluconate, magnesium sulfate); Arm II (placebo)

Ixabepilone DRUG

Given IV

Also known as: IXEMPRA

Arm I (calcium gluconate, magnesium sulfate); Arm II (placebo)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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 upper normal limit (UNL)
• Serum magnesium =\< UNL
• Serum creatinine =\< 1.5 x UNL
• Ability to sign informed consent and understand the nature of a placebo-controlled trial
• Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) of 0, 1, or 2
• Ability to complete questionnaire(s) by themselves or with assistance
• Life expectancy \>= 4 months
• Presence of a central line

You may not qualify if:

• Pre-existing history of peripheral neuropathy \>= grade 2 (National Cancer Institute \[NCI\] 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

Sponsors & Collaborators

• Mayo Clinic: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

Mayo Clinic

Rochester, Minnesota, 55905, United States

Location

MeSH Terms

Conditions

Pain; Breast Neoplasms

Interventions

Calcium Gluconate; Calcium; Magnesium Sulfate; ixabepilone

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Gluconates; Sugar Acids; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Hydroxy Acids; Carbohydrates; Metals, Alkaline Earth; Elements; Inorganic Chemicals; Metals; Blood Coagulation Factors; Biological Factors; Magnesium Compounds; Sulfates; Sulfuric Acids; Sulfur Acids; Sulfur Compounds

Results Point of Contact

• Title: Dr. Charles Loprinzi
• Organization: Mayo Clinic

cloprinzi@mayo.edu

507-266-6247

Study Officials

• Charles Loprinzi

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 19, 2009
• First Posted: October 20, 2009
• Study Start: November 1, 2009
• Primary Completion: July 1, 2010
• Study Completion: January 1, 2013
• Last Updated: February 4, 2016
• Results First Posted: August 29, 2013

Record last verified: 2015-11

Locations

US (1)