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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


Phase 1/Phase 2
18 Years
N/A
Not Enrolling
Female
Breast Cancer, Hypercalcemia of Malignancy, Metastatic Cancer, Pain

Thank you

Trial Information

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


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.

Inclusion 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

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Masking: Double-Blind, Primary Purpose: Supportive Care

Principal Investigator

Paula Silverman, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Case Comprehensive Cancer Center

Authority:

United States: Federal Government

Study ID:

CWRU-080235

NCT ID:

NCT00060138

Start Date:

November 2002

Completion Date:

Related Keywords:

  • Breast Cancer
  • Hypercalcemia of Malignancy
  • Metastatic Cancer
  • Pain
  • hypercalcemia of malignancy
  • stage IV breast cancer
  • recurrent breast cancer
  • bone metastases
  • pain
  • Breast Neoplasms
  • Neoplasms
  • Hypercalcemia
  • Neoplasm Metastasis
  • Neoplasms, Second Primary

Name

Location

Ireland Cancer CenterCleveland, Ohio  44106-5065