- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00060138
Monoclonal Antibody Compared With Zoledronate in Treating Women With Breast Cancer and Bone Metastases
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
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.
Study Overview
Status
Intervention / Treatment
Detailed Description
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.
Study Type
Phase
- Phase 2
- Phase 1
Contacts and Locations
Study Locations
-
-
Ohio
-
Cleveland, Ohio, United States, 44106-5065
- Ireland Cancer Center
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Masking: Double
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Study Chair: Paula Silverman, MD, Case Comprehensive Cancer Center
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- CWRU-080235
- CDR0000299530 (Registry Identifier: PDQ (Physician Data Query))
- CBI-1102
- CBI-CAL-03
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Pain
-
University Hospital Schleswig-HolsteinZealand University Hospital; European Regional Development Fund; Design School...CompletedPain, Acute | Pain, Chronic | Pain Measurement | Pain, CancerGermany
-
Flowonix MedicalApproved for marketingBack Pain | Leg Pain | Trunk Pain | Intractable Pain | Arm Pain
-
Dr. Negrin University HospitalCompletedPostoperative Pain, Acute | Postoperative Pain, ChronicSpain
-
George Washington UniversityRecruitingCervical Fusion | Pain, Back | Pain, Neck | Myofacial PainUnited States
-
Dow University of Health SciencesRecruitingLow Back Pain | Chronic Low-back Pain | Low Back Pain, Mechanical | Mechanical Low Back Pain | Pain, Chronic | Pain, Back | Lower Back Pain Chronic | CLBP - Chronic Low Back PainPakistan
-
Atatürk Chest Diseases and Chest Surgery Training...RecruitingPostoperative Pain | Postoperative Pain, Acute | Postoperative Pain, Chronic | VATSTurkey
-
Janssen Research & Development, LLCCompletedPain, Radiating | Pain, Burning | Pain, Crushing | Pain, Migratory | Pain, SplittingUnited States, France, Spain, Poland, Portugal
-
susanne beckerSNSFCompletedLow Back Pain | Pain, Acute | Pain, ChronicSwitzerland
-
Cairo UniversityCompletedCervical Pain | Lumbar Pain SyndromeEgypt
-
Atatürk Chest Diseases and Chest Surgery Training...RecruitingPostoperative Pain | Thoracotomy | Postoperative Pain, Acute | Postoperative Pain, ChronicTurkey
Clinical Trials on zoledronic acid
-
University of CalgaryRecruitingOsteo Arthritis Knee | Anterior Cruciate Ligament Injuries | Anterior Cruciate Ligament Rupture | Anterior Cruciate Ligament TearCanada
-
Yonsei UniversityRecruiting
-
Novartis PharmaceuticalsCompleted
-
Thomas J. SchnitzerNovartisTerminatedBone LossUnited States
-
University of CalgaryActive, not recruitingOsteoporosis | Bone Loss | Osteopenia | Osteoporosis, PostmenopausalCanada
-
Columbia UniversityNovartis PharmaceuticalsCompletedLiver Transplantation | Heart Transplantation | Bone ResorptionUnited States
-
Toufiqe-E-EalahiRecruiting
-
Children's Hospital of Eastern OntarioWithdrawnAcute Lymphoblastic Leukemia | Osteoporosis | OsteonecrosisCanada
-
Stanford UniversityNational Institutes of Health (NIH)WithdrawnBone Marrow Transplant | Hematopoietic Stem Cell Transplant
-
Novartis PharmaceuticalsCompleted