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Randomized Phase III Trial to Evaluate Radiopharmaceuticals and Zoledronic Acid in the Palliation of Osteoblastic Metastases From Lung, Breast, and Prostate Cancer

Phase 3
18 Years
Open (Enrolling)
Breast Cancer, Lung Cancer, Metastatic Cancer, Pain, Prostate Cancer

Thank you

Trial Information

Randomized Phase III Trial to Evaluate Radiopharmaceuticals and Zoledronic Acid in the Palliation of Osteoblastic Metastases From Lung, Breast, and Prostate Cancer



- Compare the efficacy of zoledronate, vitamin D, and calcium with or without strontium
chloride Sr 89 or samarium Sm 153 lexidronam pentasodium, in terms of preventing or
delaying the time to development of malignant skeletal-related events (SREs) (defined
as a pathological bone fracture, spinal cord compression, surgery to bone, or radiation
to bone) in patients with bone metastases secondary to prostate, lung, or breast


- Compare the rate of SREs at 1 year in patients treated with these regimens.

- Compare overall survival of patients treated with these regimens.

- Compare quality of life of patients treated with these regimens.

- Compare the effect of these regimens on pain control in these patients.

- Evaluate resource utilization and cost effectiveness of these regimens.

OUTLINE: This is a randomized, open-label, multicenter study. Patients are stratified
according to primary disease site (prostate vs breast vs lung) and number of bone metastases
(≤ 2 vs > 2). Patients are randomized to 1 of 2 treatment arms.

- Arm I: Patients receive zoledronate IV over 15 minutes once a month. Patients also
receive oral vitamin D and oral calcium once daily. Treatment continues in the absence
of disease progression or unacceptable toxicity.

- Arm II: Patients receive zoledronate, vitamin D, and calcium as in arm I. Within 6
weeks of beginning study treatment, patients also receive a single dose of either
strontium chloride Sr 89 IV or samarium Sm 153 lexidronam pentasodium IV.

Quality of life and pain are assessed at baseline and then at 1, 3, 6, and 12 months from
start of protocol treatment.

After completion of study treatment, patients are followed every 6 months.

PROJECTED ACCRUAL: A total of 352 patients will be accrued for this study.

Inclusion Criteria


- Histologically or cytologically confirmed lung, breast, or prostate cancer

- Bone metastases, meeting both of the following criteria:

- Must be visible on bone scan performed within the past 4 weeks

- No painful bone metastases unless successfully treated (i.e., by external-beam
irradiation) prior to study entry AND the patient has stable pain* for at least
2 weeks after that treatment NOTE: *Stable pain is defined as a patient response
of 1, 2, or 3 on Questions 4 and 5 of The Brief Pain Inventory (BPI)

- No untreated or symptomatic brain metastases

- No spinal cord compression

- Hormone receptor status not specified


- Zubrod performance status (PS) 0-2 (for patients with primary breast or prostate
cancer) OR Zubrod PS 0-1 (for patients with primary lung cancer)

- WBC ≥ 2,400/mm³

- Absolute neutrophil count ≥ 1,800/mm³

- Platelet count ≥ 60,000/mm³

- Hemoglobin ≥ 8.0 g/dL (transfusion allowed)

- Creatinine < 3.0 mg/dL

- Bilirubin < 2.5 mg/dL

- Not pregnant or nursing

- Negative pregnancy test

- Fertile patients must use effective contraception

- No uncontrolled congestive heart failure within the past 6 months

- No hypertension refractory to treatment within the past 6 months

- No symptomatic coronary artery disease within the past 6 months

- No current, active dental problems within the past 4 weeks, including any of the

- Infection of the teeth or jawbone (maxilla or mandible)

- Dental or fixture trauma

- Prior or current diagnosis of osteonecrosis of the jaw

- Exposed bone in the mouth

- Slow healing after dental procedures

- No known AIDS

- HIV testing is not required


- See Disease Characteristics

- Prior oral bisphosphonate therapy (i.e. alendronate sodium or similar) allowed

- No prior IV bisphosphonates for a treatment duration of > 6 months

- At least 2 weeks since prior calcitonin, mithramycin, or gallium nitrate

- At least 2 weeks since prior external-beam radiotherapy

- At least 6 weeks since prior and no concurrent dental surgery (e.g., extractions or

- No prior radioisotope therapy for bone metastasis

- Concurrent systemic chemotherapy* or hormonal therapy allowed

- Chemotherapy and/or hormonal therapy should not be changed within 14 days prior
to start of protocol treatment (arm I)

- No other concurrent bisphosphonate NOTE: *Chemotherapy must be held 2 weeks before
and for at least 2 weeks after radiopharmaceutical administration (arm II)

Type of Study:


Study Design:

Allocation: Randomized, Masking: Open Label, Primary Purpose: Supportive Care

Outcome Measure:

Time to development of a malignant skeletal-related events (SRE)

Safety Issue:


Principal Investigator

Michael J. Seider, MD, PhD, FACR

Investigator Role:

Study Chair

Investigator Affiliation:

Summa Center for Cancer Care at Akron City Hospital


United States: Federal Government

Study ID:




Start Date:

July 2006

Completion Date:

Related Keywords:

  • Breast Cancer
  • Lung Cancer
  • Metastatic Cancer
  • Pain
  • Prostate Cancer
  • pain
  • bone metastases
  • extensive stage small cell lung cancer
  • recurrent breast cancer
  • stage IV breast cancer
  • recurrent non-small cell lung cancer
  • stage IV non-small cell lung cancer
  • recurrent prostate cancer
  • stage IV prostate cancer
  • Breast Neoplasms
  • Lung Neoplasms
  • Neoplasm Metastasis
  • Neoplasms
  • Neoplasms, Second Primary
  • Prostatic Neoplasms



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