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| Sponsor: | University Hospitals Seidman Cancer Center |
|---|---|
| Collaborator: |
National Cancer Institute (NCI) |
| Information provided by: | National Cancer Institute (NCI) |
| ClinicalTrials.gov Identifier: | NCT00060138 |
Purpose
RATIONALE: Monoclonal antibodies can locate tumor cells and either kill them or deliver tumor-killing substances to them without harming normal cells. Zoledronate may prevent bone loss and stop the growth of tumor cells in bone. It is not yet known whether monoclonal antibody is more effective than zoledronate in treating women who have breast cancer and bone metastases.
PURPOSE: Randomized phase I/II trial to compare the effectiveness of monoclonal antibody with that of zoledronate in treating women who have breast cancer and bone metastases.
| Condition | Intervention | Phase |
|---|---|---|
|
Breast Cancer Hypercalcemia of Malignancy Metastatic Cancer Pain |
Biological: monoclonal antibody CAL Drug: zoledronic acid |
Phase I Phase II |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Masking: Double-Blind Primary Purpose: Supportive Care |
| Official Title: | 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 |
| Study Start Date: | November 2002 |
OBJECTIVES:
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.
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 study.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Radiographical evidence of at least 1 bone metastasis
Hormone receptor status:
PATIENT CHARACTERISTICS:
Age
Sex
Menopausal status
Performance status
Life expectancy
Hematopoietic
Hepatic
Renal
Other
PRIOR CONCURRENT THERAPY:
Biologic therapy
Chemotherapy
Endocrine therapy
Radiotherapy
Surgery
Other
Contacts and Locations| United States, Ohio | |
| Ireland Cancer Center | |
| Cleveland, Ohio, United States, 44106-5065 | |
| Study Chair: | Paula Silverman, MD | Case Comprehensive Cancer Center |
More Information
| ClinicalTrials.gov Identifier: | NCT00060138 History of Changes |
| Other Study ID Numbers: | CDR0000299530, CWRU-080235, CBI-1102, CBI-CAL-03 |
| Study First Received: | May 6, 2003 |
| Last Updated: | February 12, 2011 |
| Health Authority: | United States: Federal Government |
|
hypercalcemia of malignancy stage IV breast cancer recurrent breast cancer bone metastases pain |
|
Breast Neoplasms Neoplasms Hypercalcemia Neoplasm Metastasis Neoplasms, Second Primary Neoplasms by Site Breast Diseases Skin Diseases Calcium Metabolism Disorders Metabolic Diseases Water-Electrolyte Imbalance |
Neoplastic Processes Pathologic Processes Antibodies Immunoglobulins Antibodies, Monoclonal Zoledronic acid Diphosphonates Immunologic Factors Physiological Effects of Drugs Pharmacologic Actions Bone Density Conservation Agents |