Back to resultsPhase II Study of Chemotherapy and Pamidronate for the Treatment of Newly Diagnosed Osteosarcoma
Primary Purpose
Osteosarcoma
Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Cisplatin
Doxorubicin
Methotrexate
Sponsored by
About this trial
This is an interventional treatment trial for Osteosarcoma focused on measuring Cisplatin, Doxorubicin, Methotrexate, Osteosarcoma, 03-074
Eligibility 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
Sites / Locations
- Memorial Sloan-Kettering Cancer Center
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
1
Arm Description
Outcomes
Primary Outcome Measures
Radiographic Response
to the induction chemotherapy in the primary tumor and in any metastatic lesions using the Response Evaluation Criteria (RECIST).
Secondary Outcome Measures
Full Information
NCT ID
NCT00586846
First Posted
December 21, 2007
Last Updated
December 15, 2015
Sponsor
Memorial Sloan Kettering Cancer Center
1. Study Identification
Unique Protocol Identification Number
NCT00586846
Brief Title
Phase II Study of Chemotherapy and Pamidronate for the Treatment of Newly Diagnosed Osteosarcoma
Official Title
Phase II Study of Chemotherapy and Pamidronate for the Treatment of Newly Diagnosed Osteosarcoma
Study Type
Interventional
2. Study Status
Record Verification Date
December 2015
Overall Recruitment Status
Completed
Study Start Date
July 2003 (undefined)
Primary Completion Date
February 2009 (Actual)
Study Completion Date
February 2009 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Memorial Sloan Kettering Cancer Center
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Osteosarcoma
Keywords
Cisplatin, Doxorubicin, Methotrexate, Osteosarcoma, 03-074
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
40 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Cisplatin
Intervention Description
Cisplatin 120 mg/m^2
Intervention Type
Drug
Intervention Name(s)
Doxorubicin
Intervention Description
75mg/m^2
Intervention Type
Drug
Intervention Name(s)
Methotrexate
Intervention Description
Methotrexate 12g/m^2
Primary Outcome Measure Information:
Title
Radiographic Response
Description
to the induction chemotherapy in the primary tumor and in any metastatic lesions using the Response Evaluation Criteria (RECIST).
Time Frame
2 years
10. Eligibility
Sex
All
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Meyers Paul, MD
Organizational Affiliation
Memorial Sloan Kettering Cancer Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Memorial Sloan-Kettering Cancer Center
City
New York
State/Province
New York
ZIP/Postal Code
10065
Country
United States
12. IPD Sharing Statement
Links:
URL
http://www.mskcc.org
Description
Memorial Sloan-Kettering Cancer Center
Learn more about this trial
Phase II Study of Chemotherapy and Pamidronate for the Treatment of Newly Diagnosed Osteosarcoma
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