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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborators:
Novartis
Information provided by (Responsible Party):
Southwest Oncology Group
ClinicalTrials.gov Identifier:
NCT00874211
First received: April 1, 2009
Last updated: February 10, 2014
Last verified: February 2014
  Purpose

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.


Condition Intervention
Breast Cancer
Lung Cancer
Metastatic Cancer
Multiple Myeloma
Plasma Cell Neoplasm
Prostate Cancer
Unspecified Adult Solid Tumor, Protocol Specific
Procedure: assessment of therapy complications

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: S0702: A Prospective Observational Multicenter Cohort Study to Assess the Incidence of Osteonecrosis of the Jaw (ONJ) in Cancer Patients With Bone Metastases Starting Zoledronic Acid Treatment

Resource links provided by NLM:


Further study details as provided by Southwest Oncology Group:

Primary Outcome Measures:
  • Diagnosis of confirmed osteonecrosis of the jaw (ONJ) [ Time Frame: 3 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Disease-specific estimates of the confirmed cumulative incidence at 3 years of ONJ [ Time Frame: 3 years ] [ Designated as safety issue: No ]
  • Clinical presentation and natural history of ONJ [ Time Frame: 3 years ] [ Designated as safety issue: No ]
  • Overall and disease-specific cumulative incidence [ Time Frame: 3 years ] [ Designated as safety issue: No ]
  • Association of baseline factors with cumulative incidence of confirmed ONJ [ Time Frame: 3 years ] [ Designated as safety issue: No ]
  • Association between patient-related outcomes and confirmed incidence [ Time Frame: 3 years ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples With DNA

Serum for banking & whole blood for DNA analysis and banking.


Estimated Enrollment: 3500
Study Start Date: December 2008
Estimated Study Completion Date: April 2015
Estimated Primary Completion Date: April 2015 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Observation
Patients will be observed and will undergo assessment of therapy complications.
Procedure: assessment of therapy complications
By dental and medical assessments.

Detailed Description:

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

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

SWOG membership and CCOP participants through CTSU.

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00874211

  Show 453 Study Locations
Sponsors and Collaborators
Southwest Oncology Group
Novartis
Investigators
Study Chair: Catherine Van Poznak, MD University of Michigan Cancer Center
Study Chair: Julie R. Gralow, MD Seattle Cancer Care Alliance
  More Information

Additional Information:
No publications provided

Responsible Party: Southwest Oncology Group
ClinicalTrials.gov Identifier: NCT00874211     History of Changes
Other Study ID Numbers: CDR0000611929, S0702, U10CA037429
Study First Received: April 1, 2009
Last Updated: February 10, 2014
Health Authority: United States: Federal Government

Keywords provided by Southwest Oncology Group:
bone metastases
unspecified adult solid tumor, protocol specific
refractory multiple myeloma
stage I multiple myeloma
stage II multiple myeloma
stage III multiple myeloma
male breast cancer
recurrent breast cancer
stage IA breast cancer
stage IB breast cancer
stage II breast cancer
stage IIIA breast cancer
stage IIIB breast cancer
stage IIIC breast cancer
stage IV breast cancer
recurrent prostate cancer
stage I prostate cancer
stage IIB prostate cancer
stage IIA prostate cancer
stage III prostate cancer
stage IV prostate cancer
recurrent non-small cell lung cancer
stage I non-small cell lung cancer
stage II non-small cell lung cancer
stage IIIA non-small cell lung cancer
stage IIIB non-small cell lung cancer
stage IV non-small cell lung cancer
extensive stage small cell lung cancer
limited stage small cell lung cancer
recurrent small cell lung cancer

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms
Lung Neoplasms
Multiple Myeloma
Neoplasms, Plasma Cell
Plasmacytoma
Neoplasm Metastasis
Neoplasms, Second Primary
Osteonecrosis
Prostatic Neoplasms
Bone Neoplasms
Bone Marrow Diseases
Neoplasms by Site
Breast Diseases
Skin Diseases
Respiratory Tract Neoplasms
Thoracic Neoplasms
Lung Diseases
Respiratory Tract Diseases
Neoplasms by Histologic Type
Hemostatic Disorders
Vascular Diseases
Cardiovascular Diseases
Paraproteinemias
Blood Protein Disorders
Hematologic Diseases
Hemorrhagic Disorders
Lymphoproliferative Disorders
Immunoproliferative Disorders
Immune System Diseases

ClinicalTrials.gov processed this record on July 26, 2014