Osteosarcoma
Conditions
Keywords
Cisplatin, Doxorubicin, Methotrexate, Osteosarcoma, 03-074
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.
Interventions
DRUGCisplatin
Cisplatin 120 mg/m\^2
DRUGDoxorubicin
75mg/m\^2
DRUGMethotrexate
Methotrexate 12g/m\^2
Sponsors
Memorial Sloan Kettering Cancer Center
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Radiographic Response | 2 years | to the induction chemotherapy in the primary tumor and in any metastatic lesions using the Response Evaluation Criteria (RECIST). |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| All Patients Chemotherapy and Pamidronate for the Treatment of Newly Diagnosed Osteosarcoma | 40 |
| Total | 40 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Death | 1 |
| Overall Study | Evaluable for Toxicity Only | 4 |
| Overall Study | Physician Decision | 1 |
Baseline characteristics
| Characteristic | All Patients |
|---|---|
| Age, Categorical <=18 years | 31 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 9 Participants |
| Sex: Female, Male Female | 20 Participants |
| Sex: Female, Male Male | 20 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 40 / 40 |
| serious Total, serious adverse events | 25 / 40 |
Outcome results
Primary
Radiographic Response
to the induction chemotherapy in the primary tumor and in any metastatic lesions using the Response Evaluation Criteria (RECIST).
Time frame: 2 years
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| All Patients | Radiographic Response | Complete Response (CR) | 21 participants |
| All Patients | Radiographic Response | Partial Response (PR) | 5 participants |
| All Patients | Radiographic Response | Stable Disease (SD) | 5 participants |
| All Patients | Radiographic Response | Progression of Disease (POD) | 3 participants |