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

Study Description

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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

Arms and Interventions

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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, 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

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Additional Information:

Memorial Sloan-Kettering Cancer Center 

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
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