A Phase I-II, 24-Week, Multi-Center, Double-Blind, Randomized, Dose-Ranging Study To Evaluate The Safety And Efficacy Of A Humanized Monoclonal Antibody To PTHrP Versus Zoledronic Acid In Patients With Breast Cancer Metastatic To Bone
- Compare the safety and tolerability of monoclonal antibody CAL vs zoledronate in women
with breast cancer and bone metastases.
- Compare, preliminarily, the potential effects of these drugs on skeletal
events/manifestations related to bone metastases, including hypercalcemia, bone pain,
bone metastatic lesions, complications (e.g., pathologic fracture and spinal cord
compression), and interventions (e.g., surgery and radiotherapy) in these patients.
- Compare changes in ECOG performance status in patients treated with these drugs.
- Determine the pharmacokinetics of monoclonal antibody CAL in these patients.
OUTLINE: This is a randomized, double-blind, multicenter study. Patients are stratified
according to average prestudy pain score on question 3 of a daily electronic telephone pain
diary (less than 3 vs 3 or more) and prior bisphosphonate therapy (yes vs no). Patients are
randomized to 1 of 4 treatment arms.
- Arm I: Patients receive monoclonal antibody CAL IV over 30-60 minutes on day 1.
- Arm II: Patients receive a lower dose of monoclonal antibody CAL as in arm I.
- Arm III: Patients receive a lower dose (lower than arm II) of monoclonal antibody CAL
as in arm I.
- Arm IV: Patients receive zoledronate IV over 30-60 minutes on day 1. Treatment in all
arms repeats every 28 days for 6 courses in the absence of disease progression or
Patients keep a pain diary throughout study participation.
Patients are followed at 24 weeks.
PROJECTED ACCRUAL: A total of 72 patients (18 per treatment arm) will be accrued for this
Allocation: Randomized, Masking: Double-Blind, Primary Purpose: Supportive Care
Paula Silverman, MD
Case Comprehensive Cancer Center
United States: Federal Government
|Ireland Cancer Center||Cleveland, Ohio 44106-5065|