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A Placebo-Controlled Study of AZD0530 in Patients With Recurrent Osteosarcoma Localized to the Lung
This study is not yet open for participant recruitment.
Verified by Sarcoma Alliance for Research through Collaboration, December 2008
Sponsors and Collaborators: Sarcoma Alliance for Research through Collaboration
AstraZeneca
Information provided by: Sarcoma Alliance for Research through Collaboration
ClinicalTrials.gov Identifier: NCT00752206
  Purpose

The purpose of this study is to determine how long patients who undergo complete surgical removal of recurrent osteosarcoma in the lung will remain free of cancer after taking AZD0530 compared to patients taking placebo (a sugar pill).


Condition Intervention Phase
Osteosarcoma
Drug: AZD0530
Drug: Placebo
Phase II

MedlinePlus related topics: Cancer
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Randomized, Double Blind (Subject, Investigator), Parallel Assignment, Safety/Efficacy Study
Official Title: A Randomized, Double-Blinded, Placebo-Controlled, Multi-Institutional, Phase II.5 Study of AZD0530, a Selective Src Kinase Inhibitor, In Patients With Recurrent Osteosarcoma Localized to the Lung

Further study details as provided by Sarcoma Alliance for Research through Collaboration:

Primary Outcome Measures:
  • To determine the progression free survival rate among patients treated with AZD0530 and placebo. [ Time Frame: Evaluation for recurrence/progression will be made every 3 months for the 1st year, then every 6 months up to 2 years, then every year up to 5 years after starting treatment. ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 88
Study Start Date: January 2009
Estimated Study Completion Date: September 2014
Estimated Primary Completion Date: September 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
1: Active Comparator Drug: AZD0530
Oral Agent
2: Placebo Comparator Drug: Placebo
Oral Agent

Detailed Description:

Further details provided by SARC (Sarcoma Alliance for Research through Collaboration):

After complete surgical removal of their cancer, patients will be randomly assigned to receive either AZD0530 or placebo (a sugar pill) throughout the study. Patients will take AZD0530 (or placebo) once daily by mouth for a total of 364 days. The duration of treatment is divided into 13 cycles, 28 days each cycle with no breaks in between.

Patients will be seen for interim medical history, physical exam and laboratory studies prior to each cycle. To monitor for recurrence of tumor, patients will undergo thoracic CT scans at 3-4 weeks, 6-8 weeks, at 3 months, at 6 months, at 9 months, at 12 months, then every 6 months up to 2 years, and then every year up to 5 years after starting treatment. An electrocardiogram (ECG) will be taken at 3 months, and a bone scan will be performed at 12 months.

Blood and tumor samples for research purposes will be collected at the time the tumor is removed.

After completing all 13 cycles, patients will be followed for approximately every 3 months until 2 years from starting treatment, then approximately every 6 months until 4 years from starting treatment, and once at year 5.

  Eligibility

Ages Eligible for Study:   15 Years to 74 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patient had recurrence of osteosarcoma, localized to the lungs, had complete surgical removal of all lung nodules, or are deemed fully resectable.
  • Patient had histological confirmed diagnosis of osteosarcoma of the recurrent sample.
  • Patient had recurrence of osteosarcoma in the lung following standard therapy including: adriamycin, cisplatin, ifosfamide and methotrexate.
  • Patient is ≥ 15 and < 75 years of age.
  • Weight ≥ 34 kg.
  • ECOG performance score of 0-2.
  • Adequate bone marrow function.
  • Adequate renal function.
  • Adequate hepatic function.
  • Adequate cardiac function.
  • Women of childbearing potential must have had a negative pregnancy test (urine or serum) ≤ 7 days prior to enrollment, and willingness to use an acceptable method of contraception during participation in the study and for 3 months after the last dose.
  • Randomization must occur ≤ 6 weeks after complete surgical resection.
  • Patient or legal guardian has signed informed consent.

Exclusion Criteria:

  • Presence of metastatic disease in other locations in addition to the lung.
  • Disruption of the lung pleura by tumor.
  • Paget's disease.
  • Patient currently using, or has previously used CYP3A4 inducers or inhibitors within 2 to 14 days prior to the initiation of oral therapy.
  • Known hypersensitivity to other Src/Abl non-receptor kinase inhibitors.
  • Evidence of interstitial lung disease.
  • Any concurrent condition which in the investigator's opinion makes it undesirable for the patient to participate in the trial or which would jeopardize compliance with the protocol.
  • Myocardial infarction within one year prior to study entry.
  • Bleeding diathesis, resulting in symptomatic bleeding.
  • Patient is pregnant or nursing/breast-feeding.
  • Patient received chemotherapy, biological or investigational agent ≤ 28 days prior to enrollment.
  • Patient experiencing unresolved toxicity ≥ CTCAE grade 2 (except alopecia) from previous agents.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00752206

Contacts
Contact: Denise Reinke, MS, NP, President 734-930-7600 sarc@sarctrials.org
Contact: Kathleen Granlund 734-930-7607 kegranlund@sarctrials.org

Locations
United States, California
Cedars-Sinai Outpatient Cancer Center
Los Angeles, California, United States
Stanford University
Palo Alto, California, United States
United States, Iowa
University of Iowa Hospitals and Clinics
Iowa City, Iowa, United States
United States, Maryland
National Cancer Institute
Bethesda, Maryland, United States, 20892
Johns Hopkins Sidney Kimmel Comprehensive Cancer Center
Baltimore, Maryland, United States
United States, Minnesota
University of Minnesota
Minneapolis, Minnesota, United States
United States, New York
Memorial Sloan Kettering Cancer Center
New York, New York, United States
United States, North Carolina
Carolinas Hematology Oncology Associates
Charlotte, North Carolina, United States
United States, Pennsylvania
Pennsylvania Hematology Oncology Associates
Philadelphia, Pennsylvania, United States
University of Pittsburgh Cancer Institute
Pittsburgh, Pennsylvania, United States
United States, Texas
MD Anderson
Houston, Texas, United States
Sponsors and Collaborators
Sarcoma Alliance for Research through Collaboration
AstraZeneca
Investigators
Principal Investigator: Lee J Helman, MD National Cancer Institute - Pediatric Oncology Branch
  More Information

Related Info  This link exits the ClinicalTrials.gov site

Responsible Party: SARC (Sarcoma Alliance for Research through Collaboration) ( Denise Reinke, MS, NP / President )
Study ID Numbers: SARC012, D8180C00039
Study First Received: September 11, 2008
Last Updated: December 18, 2008
ClinicalTrials.gov Identifier: NCT00752206  
Health Authority: United States: Food and Drug Administration

Keywords provided by Sarcoma Alliance for Research through Collaboration:
AZD0530
Osteosarcoma
Recurrent
Osteosarcoma
Localized
to the Lung

Study placed in the following topic categories:
Neoplasms, Connective and Soft Tissue
Malignant mesenchymal tumor
Sarcoma
Osteosarcoma
Osteogenic sarcoma
Soft tissue sarcomas
Recurrence

Additional relevant MeSH terms:
Neoplasms
Neoplasms by Histologic Type
Neoplasms, Bone Tissue
Neoplasms, Connective Tissue

ClinicalTrials.gov processed this record on January 16, 2009