Monoclonal Antibody Compared With Zoledronate in Treating Women With Breast Cancer and Bone Metastases
This study has been completed.
Sponsor:
Chugai Pharmaceutical
Collaborator:
Information provided by:
Chugai Pharmaceutical
ClinicalTrials.gov Identifier:
NCT00060138
First received: May 6, 2003
Last updated: May 13, 2013
Last verified: May 2013
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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 1 Phase 2 |
| 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 |
Resource links provided by NLM:
Genetics Home Reference related topics:
breast cancer
Drug Information available for:
Zoledronic acid
U.S. FDA Resources
Further study details as provided by Chugai Pharmaceutical:
| Study Start Date: | November 2002 |
| Primary Completion Date: | September 2004 (Final data collection date for primary outcome measure) |
OBJECTIVES:
- 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 unacceptable toxicity.
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 |
Criteria
DISEASE CHARACTERISTICS:
- Histologically or cytologically confirmed breast cancer
Radiographical evidence of at least 1 bone metastasis
- No prior radiotherapy or surgery to bone metastasis
- No radiotherapy or surgery anticipated for bone metastasis within the next 24 weeks
- Bone pain severity score of at least 1 on 5 of 7 days as determined by question 3 of the Brief Pain Inventory (BPI)
- No bone metastases to a weight-bearing bone at imminent risk for pathologic fracture or surgical intervention
- No vertebral metastases that place the patient at imminent risk of spinal cord compression
Hormone receptor status:
- Not specified
PATIENT CHARACTERISTICS:
Age
- 18 and over
Sex
- Female
Menopausal status
- Pre- or post-menopausal
Performance status
- ECOG 0-2
Life expectancy
- At least 6 months
Hematopoietic
- WBC at least 2,000/mm^3
- Lymphocyte count at least 500/mm^3
- Granulocyte count at least 1,000/mm^3
- Platelet count at least 50,000/mm^3
Hepatic
- ALT or AST no greater than 2.5 times upper limit of normal (ULN)
- Bilirubin no greater than 1.5 times ULN
Renal
- Calcium no greater than 10.1 mg/dL
- No oliguria, defined as less than 30 mL urine per 2-hour collection
- No acute renal failure
- Creatinine no greater than 2.5 mg/dL
Other
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective barrier contraception
- No sepsis
- No known or anticipated contraindication to study drugs
PRIOR CONCURRENT THERAPY:
Biologic therapy
- Not specified
Chemotherapy
- More than 3 weeks since initiation of a new chemotherapy regimen
Endocrine therapy
- More than 3 weeks since initiation of a new hormonal therapy regimen
Radiotherapy
- See Disease Characteristics
- More than 3 weeks since prior radiotherapy
Surgery
- See Disease Characteristics
Other
- More than 60 days since prior bisphosphonates
- More than 30 days since prior investigational drugs
- No change in analgesic drug regimen during the screening period
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00060138
Locations
| United States, Ohio | |
| Ireland Cancer Center | |
| Cleveland, Ohio, United States, 44106-5065 | |
Sponsors and Collaborators
Chugai Pharmaceutical
Investigators
| Study Chair: | Paula Silverman, MD | Case Comprehensive Cancer Center |
More Information
Additional Information:
No publications provided
| ClinicalTrials.gov Identifier: | NCT00060138 History of Changes |
| Other Study ID Numbers: | CWRU-080235, CDR0000299530, CBI-1102, CBI-CAL-03 |
| Study First Received: | May 6, 2003 |
| Last Updated: | May 13, 2013 |
| Health Authority: | United States: Federal Government |
Keywords provided by Chugai Pharmaceutical:
|
hypercalcemia of malignancy stage IV breast cancer recurrent breast cancer bone metastases pain |
Additional relevant MeSH terms:
|
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 |
ClinicalTrials.gov processed this record on May 21, 2013