Phase II Study of Chemotherapy and Pamidronate for the Treatment of Newly Diagnosed Osteosarcoma - Full Text View

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

This study is ongoing, but not recruiting participants.

Sponsored by:	Memorial Sloan-Kettering Cancer Center
Information provided by:	Memorial Sloan-Kettering Cancer Center
ClinicalTrials.gov Identifier:	NCT00586846

Purpose

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.

Condition	Intervention	Phase
Osteosarcoma	Drug: Cisplatin Drug: Doxorubicin Drug: Methotrexate	Phase II

ChemIDplus related topics:

Doxorubicin Doxorubicin hydrochloride Cisplatin Methotrexate

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Open Label, Single Group Assignment, Safety Study

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

Further study details as provided by Memorial Sloan-Kettering Cancer Center:

Primary Outcome Measures:

Determine the safety and feasibility of administration of pamidronate with conventional chemotherapy for osteosarcoma. [ Time Frame: Conclusion of the study ] [ Designated as safety issue: Yes ]

Enrollment:	40
Study Start Date:	July 2003
Estimated Study Completion Date:	December 2008
Estimated Primary Completion Date:	December 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental	Drug: Cisplatin Cisplatin 120 mg/m2 Drug: Doxorubicin 75mg/m2 Drug: Methotrexate Methotrexate 12g/m2

Eligibility

Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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 <_1.5 upper limit of normal
Adequate liver function as defined by bilirubin <_ 1.5 X upper limit of normal and AST <_ 3 X upper limit of normal institutional range Adequate hematopoietic function as defined by platelet count >_ 100,000/ram3 an absolute neutrophil count >_ 1,000/mm3.
Adequate cardiac function as defined by shortening fraction >_ 28% by echocardiogram OR ejection fraction >_ 50% by radionuclide angiogram
Performance status <_ 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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00586846

Sponsors and Collaborators

Memorial Sloan-Kettering Cancer Center

Investigators


Principal Investigator:	Meyers Paul, Md	Memorial Sloan-Kettering Cancer Center

More Information

Responsible Party:	Memorial Sloan-Kettering Cancer Center ( Paul Meyers )
Study ID Numbers:	03-074
First Received:	December 21, 2007
Last Updated:	December 21, 2007
ClinicalTrials.gov Identifier:	NCT00586846
Health Authority:	United States: Food and Drug Administration

Keywords provided by Memorial Sloan-Kettering Cancer Center:

Cisplatin

Doxorubicin

Methotrexate

Osteosarcoma

03-074

Study placed in the following topic categories:

Folic Acid

Neoplasms, Connective and Soft Tissue

Cisplatin

Malignant mesenchymal tumor

Sarcoma

Methotrexate

Pamidronate

Osteosarcoma

Osteogenic sarcoma

Doxorubicin

Soft tissue sarcomas

Additional relevant MeSH terms:

Antimetabolites

Antimetabolites, Antineoplastic

Neoplasms by Histologic Type

Immunologic Factors

Molecular Mechanisms of Pharmacological Action

Antineoplastic Agents

Physiological Effects of Drugs

Enzyme Inhibitors

Reproductive Control Agents

Folic Acid Antagonists

Antibiotics, Antineoplastic

Abortifacient Agents, Nonsteroidal

Immunosuppressive Agents

Pharmacologic Actions

Neoplasms

Neoplasms, Bone Tissue

Radiation-Sensitizing Agents

Therapeutic Uses

Abortifacient Agents

Neoplasms, Connective Tissue

Antirheumatic Agents

Dermatologic Agents

Nucleic Acid Synthesis Inhibitors

ClinicalTrials.gov processed this record on October 03, 2008