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

This study has been completed.
Sponsor:
Collaborator:
Information provided by:
Chugai Pharmaceutical
ClinicalTrials.gov Identifier:
NCT00060138
First received: May 6, 2003
Last updated: May 13, 2013
Last verified: May 2013
  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:


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)
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.

  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 April 17, 2014