The ODYSSEY TRIAL Phase IV Trial Evaluating the Palliative Benefit of Pamidronate or Zoledronic Acid in Breast Cancer
Information source: Ottawa Hospital Research Institute
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Breast Cancer
Intervention: Pamidronate (Drug); Zoledronic acid (Drug); placebo (Drug)
Phase: Phase 4
Status: Active, not recruiting
Sponsored by: Ottawa Hospital Research Institute Official(s) and/or principal investigator(s): Mark Clemons, Dr., Principal Investigator, Affiliation: The Ottawa Hospital
Summary
Metastatic breast cancer patients with bone involvement who are at high-risk of subsequent
skeletal related event (SRE), defined as radiotherapy or surgery to the bone, pathological
fracture, spinal cord compression, or hypercalcemia (as reflected through: elevated sCTX or
bone pain or a prior SRE despite receiving standard bisphosphonate therapy) should
experience a decrease in the surrogate marker, sCTX, at week 12 if switched to zoledronic
acid compared with those patients who continue on intravenous pamidronate (i. e. current
standard of care). The investigators propose that a drop in sCTX will correlate with
improved pain, quality of life and a reduced incidence of further SREs.
Clinical Details
Official title: A Randomized, Double-blind, Placebo-controlled, Phase IV Trial Evaluating the Palliative Benefit of Either Continuing Pamidronate or Switching to Second-line Zoledronic Acid in Breast Cancer Patients With High-risk Bone Metastases.
Study design: Allocation: Randomized, Endpoint Classification: Bio-equivalence Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment
Primary outcome: sCTX values
Secondary outcome: Palliative response
Detailed description:
This study will be a prospective, randomized, double-blind, placebo controlled, Phase IV
study of pamidronate vs. zoledronic acid in women with breast cancer and bone metastases.
Patients who are at high-risk of subsequent SREs will be screened for entry into this study.
High-risk will be defined as fulfilling one or more of the following criteria: elevated sCTX
(>400ng/L) and/or bone pain and/or a prior SRE and/or progression of bone disease (by
imaging) despite at least 3 months of pamidronate therapy. Patients who meet the eligibility
criteria, will be randomized to receive 3 cycles of intravenous zoledronic acid (4mg
intravenously over 15 minutes) or to continue their standard dose of pamidronate. Both
treatments will be given at 4 week intervals. Patients will be stratified according to
whether or not they have had a SRE prior to study entry, progressive bone disease or bone
pain. In order for the study to be double-blind, patients will receive two infusions
simultaneously, at each study visit, one of the active drug and another of the placebo.
After completing 3 cycles of study treatment, patients will resume their monthly intravenous
pamidronate infusions as per current standard of care.
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Female.
Criteria:
Inclusion Criteria:
1. Metastatic breast cancer to the bone with radiologically confirmed bone metastases
2. High-risk of subsequent SRE as reflected through either: elevated serum CTX (>
400ng/L) and/or bone pain (using BPI) and/or prior SRE while on bisphosphonate
therapy and/or progressive bone metastasis (by imaging)
3. On pamidronate therapy for at least 3 months
4. ECOG ≤ 2 and life expectancy > 3 months
5. Serum creatinine ≤ 2. 0 × ULN (zoledronic acid or pamidronate to be renal dosed as per
institution standard)
6. No changes in systemic treatment in the 4 weeks prior to study entry or anticipated
changes in the 4 weeks after entering the study. Markers of bone formation can be
affected by a change in systemic therapies
7. Ability to take calcium and Vitamin D as per Health Canada recommended daily doses
for the duration of the study
8. Ability to provide informed consent and complete study evaluations.
Exclusion Criteria:
1. Patients with acute symptomatic pathological fractures or acute spinal cord
compression until such time as the appropriate management (surgery and/or
radiotherapy) has been completed
2. Acute hypercalcemia (>3. 5 mmol/L)
3. Hypersensitivity to any bisphosphonate
4. Patients with rapidly progressive non-bone metastases for whom delaying a change in
systemic anti-cancer treatment for the 1 month biochemical marker evaluation period
could have a detrimental impact on patient outcome.
5. Renal dysfunction (≥ 2x creatinine of the upper limit of normal )
6. Pregnancy or lactation
7. Patients with dental abscesses or patients potentially requiring tooth extraction
while on study
Locations and Contacts
The Ottawa Hospital Cancer Centre, Ottawa, Ontario K1H 8L6, Canada
Additional Information
Starting date: August 2012
Last updated: April 21, 2015
|