Phase 2
N=40
Phase II Study of Chemotherapy and Pamidronate for the Treatment of Newly Diagnosed Osteosarcoma
Osteosarcoma
Bottom Line
View on ClinicalTrials.gov: NCT00586846 ↗Enrolled (actual)
40
Serious AEs
62.5%
Results posted
Jan 2016
Primary outcome: Primary: Radiographic Response — 21; 5; 5; 3 participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Cisplatin (Drug); Doxorubicin (Drug); Methotrexate (Drug)
- Age
- Pediatric, Adult, Older Adult
- Sex
- All
- Sponsor
- Memorial Sloan Kettering Cancer Center
- Primary completion
- Feb 2009
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Radiographic Response |
21; 5; 5; 3 | — |
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.
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 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
Data sourced from ClinicalTrials.gov (NCT00586846). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.