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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00060138
Recruitment Status : Completed
First Posted : May 7, 2003
Last Update Posted : May 15, 2013
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by:
Chugai Pharmaceutical

Tracking Information
First Submitted Date  ICMJE May 6, 2003
First Posted Date  ICMJE May 7, 2003
Last Update Posted Date May 15, 2013
Study Start Date  ICMJE November 2002
Actual Primary Completion Date September 2004   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE Not Provided
Original Primary Outcome Measures  ICMJE Not Provided
Change History Complete list of historical versions of study NCT00060138 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Monoclonal Antibody Compared With Zoledronate in Treating Women With Breast Cancer and Bone Metastases
Official Title  ICMJE 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
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Phase 2
Study Design  ICMJE Allocation: Randomized
Masking: Double
Primary Purpose: Supportive Care
Condition  ICMJE
  • Breast Cancer
  • Hypercalcemia of Malignancy
  • Metastatic Cancer
  • Pain
Intervention  ICMJE
  • Biological: monoclonal antibody CAL
  • Drug: zoledronic acid
Study Arms  ICMJE Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Enrollment  ICMJE Not Provided
Original Enrollment  ICMJE Not Provided
Study Completion Date  ICMJE Not Provided
Actual Primary Completion Date September 2004   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00060138
Other Study ID Numbers  ICMJE CWRU-080235
CDR0000299530 ( Registry Identifier: PDQ (Physician Data Query) )
CBI-1102
CBI-CAL-03
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Not Provided
Study Sponsor  ICMJE Chugai Pharmaceutical
Collaborators  ICMJE National Cancer Institute (NCI)
Investigators  ICMJE
Study Chair: Paula Silverman, MD Case Comprehensive Cancer Center
PRS Account Chugai Pharmaceutical
Verification Date May 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP