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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00586846
First Posted: January 7, 2008
Last Update Posted: January 20, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Memorial Sloan Kettering Cancer Center
  Purpose
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 Intervention Phase
Osteosarcoma Drug: Cisplatin Drug: Doxorubicin Drug: Methotrexate Phase 2

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Memorial Sloan Kettering Cancer Center:

Primary Outcome Measures:
  • 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).


Enrollment: 40
Study Start Date: July 2003
Study Completion Date: February 2009
Primary Completion Date: February 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 Drug: Cisplatin
Cisplatin 120 mg/m^2
Drug: Doxorubicin
75mg/m^2
Drug: Methotrexate
Methotrexate 12g/m^2

  Eligibility

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   Child, Adult, Senior
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
Information from the National Library of Medicine

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

Additional Information:
Responsible Party: Memorial Sloan Kettering Cancer Center
ClinicalTrials.gov Identifier: NCT00586846     History of Changes
Obsolete Identifiers: NCT00072306
Other Study ID Numbers: 03-074
First Submitted: December 21, 2007
First Posted: January 7, 2008
Results First Submitted: December 15, 2015
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


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