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S0702: Osteonecrosis of the Jaw in Patients With Cancer Receiving Zoledronic Acid for Bone Metastases

Basic Trial Information
Trial Description
     Summary
     Further Trial Information
     Eligibility Criteria
Trial Contact Information

Basic Trial Information

PhaseTypeStatusAgeSponsorProtocol IDs
No phase specifiedNatural history/EpidemiologyClosedNot specifiedNCI, OtherCDR0000611929
S0702, U10CA037429, SWOG-S0702, NCT00874211

Trial Description

Summary

RATIONALE: Gathering information about how often osteonecrosis of the jaw occurs in patients receiving zoledronic acid for bone metastases may help doctors learn more about the disease and provide the best follow-up care.

PURPOSE: This clinical trial is studying osteonecrosis of the jaw in patients with cancer who are receiving zoledronic acid for bone metastases.

Further Study Information

OBJECTIVES:

Primary

  • To prospectively access the cumulative incidence of osteonecrosis of the jaw (ONJ) at 3 years in cancer patients with bone metastasis receiving zoledronic acid treatment.

Secondary

  • To describe the clinical presentation and natural history of ONJ.
  • To identify potential risk factors for the development of ONJ.
  • To estimate the cumulative incidence of ONJ at 3 years for different tumor types (i.e., breast cancer, multiple myeloma, prostate cancer, lung cancer, and other cancers).
  • To better define the patient-related outcomes of ONJ.

OUTLINE: This is a multicenter study.

Patients undergo dental assessments at baseline and every 3-6 months for 3 years.

Eligibility Criteria

DISEASE CHARACTERISTICS:

  • Participant must have bone metastasis from multiple myeloma, solid tumors, or other malignancy for which intravenous bisphosphonate has clinical indications in the treatment of metastatic bone disease
  • Treatment with osteoclast inhibition is clinically indicated
  • Must be planning to receive zoledronic acid* within the next 30 days NOTE: *Osteoclast inhibition therapy will continue thereafter as clinically indicated.
  • No prior diagnosis of osteonecrosis of the jaw
  • Patients previously treated with osteoclast inhibition therapy are eligible, provided the following criteria apply:
  • Prior osteoclast inhibition for low bone mass (osteoporosis or osteopenia):
  • Patients may have previously received at most 3 doses of osteoclast-inhibiting therapy with denosumab, IV ibandronate, pamidronate, or zoledronic acid for low bone mass (osteopenia or osteoporosis) within 3 years prior to registration
  • Prior oral bisphosphonate therapy at osteoporosis or osteopenia dosing at any time prior to registration is allowed
  • Prior exposures to other medications used to treat low bone mass at osteoporosis or osteopenia dosing are permitted
  • Prior osteoclast inhibition for metastatic bone disease (tumor involving bone):
  • Patients may have previously received osteoclast-inhibiting therapy with denosumab, ibandronate (oral or IV cancer dosing), pamidronate, or zoledronic acid to treat metastatic bone disease within 180 days prior to registration
  • Patients receiving these regimens for metastatic bone disease prior to 180 days before registration are not eligible
  • Prior osteoclast-inhibiting therapy at higher dosing than outlined above at any time prior to registration is not allowed

PATIENT CHARACTERISTICS:

  • Zubrod performance status 0-3
  • Patients who may be acutely ill from spinal cord compromise, hypercalcemia of malignancy, or other process may be study candidates once the acute condition has been addressed and performance status improves to 0-3
  • Not pregnant or nursing
  • Negative pregnancy test
  • Willing and physically able to comply with study procedures and assessments
  • Willing to provide information on personal history, including tobacco and alcohol use, and pain assessment
  • Willing to provide access to prior and future dental information
  • No other prior malignancy except for any of the following:
  • Adequately treated basal cell carcinoma or squamous cell carcinoma of the skin
  • In situ cervical cancer
  • Adequately treated stage I or II cancer for which the patient is currently in complete remission
  • Any other cancer for which the patient has been disease-free for 5 years

PRIOR CONCURRENT THERAPY:

  • See Disease Characteristics
  • No history of radiation to the maxillofacial area administered for therapeutic intent in the treatment of cancer
  • Concurrent participation in other therapeutic and non-therapeutic clinical trials allowed
  • The sum of prior IV bisphosphonate doses must not be greater than 10
  • The sum of prior denosumab doses must not be greater than 8
  • The total of both IV bisphosphonate and denosumab used for any indication must not be greater than 12 doses

Trial Contact Information

Trial Lead Organizations/Sponsors

Southwest Oncology Group

National Cancer Institute

Novartis Pharmaceuticals Corporation

Catherine Van PoznakStudy Chair

Julie R. GralowStudy Chair

Trial Sites

U.S.A.
California
  Concord
 Cancer Care Center at John Muir Health - Concord Campus
 Deborah L. Kerlin Ph: 925-674-2580
  Pleasant Hill
 East Bay Medical Oncology Hematology Associates - Pleasant Hill
 James H. Feusner Ph: 510-450-7600
  Pleasanton
 Valley Medical Oncology Consultants - Pleasanton
 Helen K. Chew Ph: 916-734-3089
  Walnut Creek
 John Muir/Mt. Diablo Comprehensive Cancer Center
 Deborah L. Kerlin Ph: 925-674-2580
Indiana
  Beech Grove
 St. Francis Hospital and Health Centers - Beech Grove Campus
 Howard M. Gross Ph: 765-983-3000
Michigan
  Detroit
 Wayne State University
 Lawrence E. Flaherty Ph: 313-576-9363
  Flint
 Genesys Hurley Cancer Institute
 Philip J. Stella Ph: 734-712-3456
Nevada
  Las Vegas
 Nevada Cancer Institute
 Robert P. Whitehead Ph: 702-822-5136
New York
  Brooklyn
 Veterans Affairs Medical Center - Brooklyn
 Andrea Nadine Wiesel Leaf Ph: 800-877-6976
North Carolina
  Rutherfordton
 Rutherford Hospital
 James Dewitt Bearden Ph: 800-486-5941
Oregon
  Salem
 Salem Hospital Regional Cancer Care Services
 Edward Peter Orlowski Ph: 503-561-2618
South Carolina
  Anderson
 AnMed Cancer Center
 James Dewitt Bearden Ph: 800-486-5941
Texas
  San Antonio
 Southwest Oncology Group
 Catherine Van Poznak Ph: 734-936-9209
  Email: cvanpoz@med.umich.edu
 Catherine Van Poznak Ph: 734-936-9209
  Email: cvanpoz@med.umich.edu

Link to the current ClinicalTrials.gov record.
NLM Identifer NCT00874211
ClinicalTrials.gov processed this data on February 11, 2014

Note: Information about this trial is from the ClinicalTrials.gov database. The versions designated for health professionals and patients contain the same text. Minor changes may be made to the ClinicalTrials.gov record to standardize the names of study sponsors, sites, and contacts. Cancer.gov only lists sites that are recruiting patients for active trials, whereas ClinicalTrials.gov lists all sites for all trials. Questions and comments regarding the presented information should be directed to ClinicalTrials.gov.

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