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

Phase 2
Not Enrolling

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Trial Information

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

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

Type of Study:


Study Design:

Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Determine the safety and feasibility of administration of pamidronate with conventional chemotherapy for osteosarcoma.

Outcome Time Frame:

Conclusion of the study

Safety Issue:


Principal Investigator

Meyers Paul, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Memorial Sloan-Kettering Cancer Center


United States: Food and Drug Administration

Study ID:




Start Date:

July 2003

Completion Date:

February 2009

Related Keywords:

  • Osteosarcoma
  • Cisplatin
  • Doxorubicin
  • Methotrexate
  • Osteosarcoma
  • 03-074
  • Osteosarcoma



Memorial Sloan-Kettering Cancer Center New York, New York  10021