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

Inclusion Criteria

DISEASE CHARACTERISTICS:

- 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

PATIENT CHARACTERISTICS:

- 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
following:

- 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

PRIOR CONCURRENT THERAPY:

- 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
implants)

- 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)