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

Phase 2

Completed

• Conditions: Osteosarcoma
• Interventions: Drug: Cisplatin; Drug: Doxorubicin; Drug: Methotrexate

• Registration Number: NCT00586846
• Lead Sponsor: Memorial Sloan Kettering Cancer Center

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2003-07
• Study First Submitted: 2007-12-21
• Study First Submitted QC: 2007-12-21
• Study First Posted: 2008-01-07
• Primary Completion: 2009-02
• Study Completion: 2009-02
• Status Verified: 2015-12
• Results First Submitted: 2015-12-15
• Results First Submitted QC: 2015-12-15
• Last Update Submitted: 2015-12-15
• Results First Posted: 2016-01-20
• Last Update Posted: 2016-01-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
1	Doxorubicin	-
1	Cisplatin	-
1	Methotrexate	-

Primary Outcome Measures

Name	Time	Method
Radiographic Response	2 years	to the induction chemotherapy in the primary tumor and in any metastatic lesions using the Response Evaluation Criteria (RECIST).

Trial Locations

Locations (1)

Memorial Sloan-Kettering Cancer Center; 🇺🇸 New York, New York, United States