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
|
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Osteosarcoma | Drug: Cisplatin Drug: Doxorubicin Drug: Methotrexate | Phase 2 |
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 |
Arm | Intervention/treatment |
---|---|
Experimental: 1 |
Drug: Cisplatin
Cisplatin 120 mg/m^2
Drug: Doxorubicin
75mg/m^2
Drug: Methotrexate
Methotrexate 12g/m^2
|
- 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).

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Ages Eligible for Study: | Child, Adult, Senior |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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

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
United States, New York | |
Memorial Sloan-Kettering Cancer Center | |
New York, New York, United States, 10065 |
Principal Investigator: | Meyers Paul, MD | Memorial Sloan Kettering Cancer Center |
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 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 |