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Phase II Study of Chemotherapy and Pamidronate for the Treatment of Newly Diagnosed Osteosarcoma

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ClinicalTrials.gov Identifier: NCT00586846
Recruitment Status : Completed
First Posted : January 7, 2008
Results First Posted : January 20, 2016
Last Update Posted : January 20, 2016
Sponsor:
Information provided by (Responsible Party):
Memorial Sloan Kettering Cancer Center

Study Description
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Brief Summary:
This study is designed to test the safety and feasibility of the simultaneous administration of a biphosphonate with chemotherapy for the treatment of osteosarcoma in newly diagnosed patients.

Condition or disease Intervention/treatment Phase
Osteosarcoma Drug: Cisplatin Drug: Doxorubicin Drug: Methotrexate Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 40 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase II Study of Chemotherapy and Pamidronate for the Treatment of Newly Diagnosed Osteosarcoma
Study Start Date : July 2003
Actual Primary Completion Date : February 2009
Actual Study Completion Date : February 2009

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Arms and Interventions
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Arm Intervention/treatment
Experimental: 1 Drug: Cisplatin
Cisplatin 120 mg/m^2

Drug: Doxorubicin
75mg/m^2

Drug: Methotrexate
Methotrexate 12g/m^2


Outcome Measures
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Primary Outcome Measures :
  1. Radiographic Response [ Time Frame: 2 years ]
    to the induction chemotherapy in the primary tumor and in any metastatic lesions using the Response Evaluation Criteria (RECIST).


Eligibility Criteria
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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Newly diagnosed, previously untreated biopsy proven high-grade osteosarcoma. Patient who have undergone a definitive surgical resection as their primary surgery are still eligible for participation in this study.
  • No prior chemotherapy or radiation therapy
  • Adequate renal function: creatinine < or = to 1.5 upper limit of normal
  • Adequate liver function as defined by bilirubin < or = to 1.5 X upper limit of normal and AST < or = to 3 X upper limit of normal institutional range Adequate hematopoietic function as defined by platelet count > or = to 100,000/ram3 an absolute neutrophil count > or = to 1,000/mm3.
  • Adequate cardiac function as defined by shortening fraction > or = to 28% by echocardiogram OR ejection fraction > or = to 50% by radionuclide angiogram
  • Performance status < or = to 2

Exclusion Criteria:

  • Prior history of cancer
  • Prior treatment for cancer
  • Prior history of Paget's disease
  • Prior history of pericarditis, myocarditis, symptomatic arrhythmia or symptomatic cardiac conduction abnormalities
  • Pregnancy or breast feeding
Contacts and Locations
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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00586846


Locations
United States, New York
Memorial Sloan-Kettering Cancer Center
New York, New York, United States, 10065
Sponsors and Collaborators
Memorial Sloan Kettering Cancer Center
Investigators
Principal Investigator: Meyers Paul, MD Memorial Sloan Kettering Cancer Center
More Information
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Additional Information:
Memorial Sloan-Kettering Cancer Center  This link exits the ClinicalTrials.gov site

Responsible Party: Memorial Sloan Kettering Cancer Center
ClinicalTrials.gov Identifier: NCT00586846     History of Changes
Obsolete Identifiers: NCT00072306
Other Study ID Numbers: 03-074
First Posted: January 7, 2008    Key Record Dates
Results First Posted: January 20, 2016
Last Update Posted: January 20, 2016
Last Verified: December 2015

Keywords provided by Memorial Sloan Kettering Cancer Center:
Cisplatin
Doxorubicin
Methotrexate
Osteosarcoma
03-074

Additional relevant MeSH terms:
Osteosarcoma
Neoplasms, Bone Tissue
Neoplasms, Connective Tissue
Neoplasms, Connective and Soft Tissue
Neoplasms by Histologic Type
Neoplasms
Sarcoma
Liposomal doxorubicin
Cisplatin
Doxorubicin
Methotrexate
Antineoplastic Agents
Antibiotics, Antineoplastic
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
 Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Abortifacient Agents, Nonsteroidal
Abortifacient Agents
Reproductive Control Agents
Physiological Effects of Drugs
Antimetabolites, Antineoplastic
Antimetabolites
Dermatologic Agents
Folic Acid Antagonists
Immunosuppressive Agents
Immunologic Factors
Antirheumatic Agents
Nucleic Acid Synthesis Inhibitors