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

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2003-07-31

Study Completion Date

2009-02-28

Brief Summary

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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.

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Detailed Description

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Conditions

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Osteosarcoma

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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1

Group Type EXPERIMENTAL

Cisplatin

Intervention Type DRUG

Cisplatin 120 mg/m\^2

Doxorubicin

Intervention Type DRUG

75mg/m\^2

Methotrexate

Intervention Type DRUG

Methotrexate 12g/m\^2

Interventions

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Cisplatin

Cisplatin 120 mg/m\^2

Intervention Type DRUG

Doxorubicin

75mg/m\^2

Intervention Type DRUG

Methotrexate

Methotrexate 12g/m\^2

Intervention Type DRUG

Eligibility Criteria

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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

Eligible Sex

ALL

Accepts Healthy Volunteers

No