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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

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Trial Conditions
  • Breast Cancer
  • Lung Cancer
  • Metastatic Cancer
  • Neoplasm Metastasis
  • Pain
  • Prostate Cancer
What is the purpose of this trial?

RATIONALE: Zoledronate, vitamin D and calcium may prevent or delay bone pain and other symptoms caused by bone metastases. It is not yet known whether giving zoledronate together with vitamin D and calcium is more effective with or without strontium 89 or samarium 153 in treating patients with bone metastases from prostate cancer, lung cancer, or breast cancer. PURPOSE: This randomized phase III trial is studying zoledronate, vitamin D, and calcium to see how well they work compared to zoledronate, vitamin D, calcium, and either strontium 89 or samarium 153 in preventing or delaying bone problems in patients with bone metastases from prostate cancer, lung cancer, or breast cancer.

Date & Status

Active, not recruiting

Who can Participate?

Eligibility

Ages:
18 and older

Gender:
Both

Eligibility

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)

- White blood cell count (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)

Gender: Both
Steward Physician(s)
  • Michael J. Seider, MD, PhD, FACR
Facilities
  • Saint Anne's Hospital - Active, not recruiting
Trial Interventions
Dietary Supplement
  • Calcium
  • Vitamin D
Drug
  • zoledronic acid
  • Sm-153
Radiation
  • Sr-89
Physician Researcher

Investigator Name:

  • Michael J. Seider, MD, PhD, FACR

Other Information

Sponsor: Radiation Therapy Oncology Group
Phase: Phase 3
Trial ID: NCT00365105
Volunteers:  Not Accepting Healthy Volunteers

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