Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outline
Trial Contact Information
Registry Information

Alternate Title

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

Basic Trial Information

Phase	Type	Status	Age	Sponsor	Protocol IDs
Phase II, Phase I	Supportive care, Treatment	Closed	18 and over	NCI, Pharmaceutical / Industry	CWRU-080235 CBI-1102, CBI-CAL-03, NCT00060138

Objectives

1. Compare the safety and tolerability of monoclonal antibody CAL vs zoledronate in women with breast cancer and bone metastases.
2. 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.
3. Compare changes in ECOG performance status in patients treated with these drugs.
4. Determine the pharmacokinetics of monoclonal antibody CAL in these patients.

Entry 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

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

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/mm³
• Lymphocyte count at least 500/mm³
• Granulocyte count at least 1,000/mm³
• Platelet count at least 50,000/mm³

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

Expected Enrollment

A total of 72 patients (18 per treatment arm) will be accrued for this study.

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.

Trial Contact Information

Trial Lead Organizations

Ireland Cancer Center at University Hospitals/Case Medical Center

Paula Silverman, MD, Protocol chair		Ph: 216-844-8510 Email: pxs7@case.edu

Registry Information
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
Trial Start Date		2002-11-26
Registered in ClinicalTrials.gov		NCT00060138
Date Submitted to PDQ		2003-03-19
Information Last Verified		2004-06-03
NCI Grant/Contract Number		P30-CA43703

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