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Monoclonal Antibody Compared With Zoledronate in Treating Women With Breast Cancer and Bone Metastases

Primary Purpose

Breast Cancer, Hypercalcemia of Malignancy, Metastatic Cancer

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
monoclonal antibody CAL
zoledronic acid
Sponsored by
Chugai Pharmaceutical
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Breast Cancer focused on measuring hypercalcemia of malignancy, stage IV breast cancer, recurrent breast cancer, bone metastases, pain

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • Ireland Cancer Center

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
May 6, 2003
Last Updated
May 13, 2013
Sponsor
Chugai Pharmaceutical
Collaborators
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT00060138
Brief Title
Monoclonal Antibody Compared With Zoledronate in Treating Women With Breast Cancer and Bone Metastases
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 Type
Interventional

2. Study Status

Record Verification Date
May 2013
Overall Recruitment Status
Completed
Study Start Date
November 2002 (undefined)
Primary Completion Date
September 2004 (Actual)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Chugai Pharmaceutical
Collaborators
National Cancer Institute (NCI)

4. Oversight

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer, Hypercalcemia of Malignancy, Metastatic Cancer, Pain
Keywords
hypercalcemia of malignancy, stage IV breast cancer, recurrent breast cancer, bone metastases, pain

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Phase 1, Phase 2
Masking
Double
Allocation
Randomized

8. Arms, Groups, and Interventions

Intervention Type
Biological
Intervention Name(s)
monoclonal antibody CAL
Intervention Type
Drug
Intervention Name(s)
zoledronic acid

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Paula Silverman, MD
Organizational Affiliation
Case Comprehensive Cancer Center
Official's Role
Study Chair
Facility Information:
Facility Name
Ireland Cancer Center
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44106-5065
Country
United States

12. IPD Sharing Statement

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Monoclonal Antibody Compared With Zoledronate in Treating Women With Breast Cancer and Bone Metastases

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