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Zoledronate, Vitamin D, and Calcium With or Without Strontium 89 or Samarium 153 in Preventing or Delaying Bone Problems in Patients With Bone Metastases From Prostate Cancer, Lung Cancer, or Breast Cancer

The recruitment status of this study is unknown because the information has not been verified recently.
Verified February 2011 by National Cancer Institute (NCI).
Recruitment status was  Active, not recruiting
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00365105
First received: August 16, 2006
Last updated: June 26, 2012
Last verified: February 2011
History of Changes
  Purpose

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.


Condition Intervention Phase
Breast Cancer
Lung Cancer
Metastatic Cancer
Pain
Prostate Cancer
 Dietary Supplement: calcium carbonate
Dietary Supplement: calcium citrate
Dietary Supplement: calcium glucarate
Dietary Supplement: vitamin D
Drug: calcium gluconate
Drug: zoledronic acid
Radiation: samarium Sm 153 lexidronam pentasodium
Radiation: strontium chloride Sr 89
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Masking: Open Label
Primary Purpose: Supportive Care
Official Title: Randomized Phase III Trial to Evaluate Radiopharmaceuticals and Zoledronic Acid in the Palliation of Osteoblastic Metastases From Lung, Breast, and Prostate Cancer

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:
  • Time to development of a malignant skeletal-related events (SRE) [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • SRE rate at 1 year [ Designated as safety issue: No ]
  • Overall survival [ Designated as safety issue: No ]
  • Changes in quality of life as measured by FACT-G [ Designated as safety issue: No ]
  • Changes in pain control as measured by Brief Pain Inventory (BPI) [ Designated as safety issue: No ]
  • Utility and cost effectiveness of the use of radiopharmaceuticals and bisphosphonates as measured by the EuroQol-5 Dimension (EQ-5D) [ Designated as safety issue: No ]

Estimated Enrollment: 352
Study Start Date: July 2006
Estimated Primary Completion Date: March 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 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.
 Dietary Supplement: calcium carbonate
Zoledronic acid given IV; vitamin D and calcium given orally
Dietary Supplement: calcium citrate
Zoledronic acid given IV; vitamin D and calcium given orally
Dietary Supplement: calcium glucarate
Zoledronic acid given IV; vitamin D and calcium given orally
Dietary Supplement: vitamin D
Zoledronic acid given IV; vitamin D and calcium given orally
Drug: calcium gluconate
Zoledronic acid given IV; vitamin D and calcium given orally
Drug: zoledronic acid
Zoledronic acid given IV; vitamin D and calcium given orally
Experimental: 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.
 Dietary Supplement: calcium carbonate
Zoledronic acid given IV; vitamin D and calcium given orally
Dietary Supplement: calcium citrate
Zoledronic acid given IV; vitamin D and calcium given orally
Dietary Supplement: calcium glucarate
Zoledronic acid given IV; vitamin D and calcium given orally
Dietary Supplement: vitamin D
Zoledronic acid given IV; vitamin D and calcium given orally
Drug: calcium gluconate
Zoledronic acid given IV; vitamin D and calcium given orally
Drug: zoledronic acid
Zoledronic acid given IV; vitamin D and calcium given orally
Radiation: samarium Sm 153 lexidronam pentasodium
Given IV
Radiation: strontium chloride Sr 89
Given IV

Detailed Description:

OBJECTIVES:

Primary

  • 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 cancer.

Secondary

  • 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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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)
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00365105

  Show 147 Study Locations
Sponsors and Collaborators
Radiation Therapy Oncology Group
National Cancer Institute (NCI)
Investigators
Study Chair: Michael J. Seider, MD, PhD, FACR Summa Center for Cancer Care at Akron City Hospital
  More Information

Additional Information:
Clinical trial summary from the National Cancer Institute's PDQ® database  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: Walter John Curran, Jr, Radiation Therapy Oncology Group
ClinicalTrials.gov Identifier: NCT00365105     History of Changes
Other Study ID Numbers: CDR0000491233, RTOG-0517
Study First Received: August 16, 2006
Last Updated: June 26, 2012
Health Authority: United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
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

Additional relevant MeSH terms:
Breast Neoplasms
Lung Neoplasms
Neoplasm Metastasis
Neoplasms
Neoplasms, Second Primary
Prostatic Neoplasms
Neoplasms by Site
Breast Diseases
Skin Diseases
Respiratory Tract Neoplasms
Thoracic Neoplasms
Lung Diseases
Respiratory Tract Diseases
Neoplastic Processes
Pathologic Processes
 Genital Neoplasms, Male
Urogenital Neoplasms
Genital Diseases, Male
Prostatic Diseases
Zoledronic acid
Calcium, Dietary
Vitamin D
Ergocalciferols
Diphosphonates
Calcium Carbonate
Vitamins
Samarium ethylenediaminetetramethylenephosphonate
Bone Density Conservation Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on June 18, 2013