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

This study has been completed.

Sponsor:

Information provided by (Responsible Party):

Memorial Sloan Kettering Cancer Center

ClinicalTrials.gov Identifier:

NCT00586846

First received: December 21, 2007

Last updated: December 15, 2015

Last verified: December 2015

History of Changes

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 2


Study Type:	Interventional
Study Design:	Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	Phase II Study of Chemotherapy and Pamidronate for the Treatment of Newly Diagnosed Osteosarcoma

Resource links provided by NLM:

Genetic and Rare Diseases Information Center resources: Osteosarcoma Soft Tissue Sarcoma

U.S. FDA Resources

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

Primary Outcome Measures:

Radiographic Response [ Time Frame: 2 years ]
to the induction chemotherapy in the primary tumor and in any metastatic lesions using the Response Evaluation Criteria (RECIST).


Enrollment:	40
Study Start Date:	July 2003
Study Completion Date:	February 2009
Primary Completion Date:	February 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: 1	Drug: Cisplatin Cisplatin 120 mg/m^2 Drug: Doxorubicin 75mg/m^2 Drug: Methotrexate Methotrexate 12g/m^2

Eligibility


Ages Eligible for Study:	Child, Adult, Senior
Sexes Eligible for Study:	All
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 < 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

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Locations


United States, New York
Memorial Sloan-Kettering Cancer Center
New York, New York, United States, 10065

Sponsors and Collaborators

Memorial Sloan Kettering Cancer Center

Investigators


Principal Investigator:	Meyers Paul, MD	Memorial Sloan Kettering Cancer Center

More Information

Additional Information:

Memorial Sloan-Kettering Cancer Center This link exits the ClinicalTrials.gov site


Responsible Party:	Memorial Sloan Kettering Cancer Center
ClinicalTrials.gov Identifier:	NCT00586846 History of Changes
Obsolete Identifiers:	NCT00072306
Other Study ID Numbers:	03-074
Study First Received:	December 21, 2007
Results First Received:	December 15, 2015
Last Updated:	December 15, 2015

Keywords provided by Memorial Sloan Kettering Cancer Center:


Cisplatin Doxorubicin Methotrexate Osteosarcoma 03-074

Additional relevant MeSH terms:


Osteosarcoma Neoplasms, Bone Tissue Neoplasms, Connective Tissue Neoplasms, Connective and Soft Tissue Neoplasms by Histologic Type Neoplasms Sarcoma Liposomal doxorubicin Cisplatin Methotrexate Doxorubicin Antineoplastic Agents Abortifacient Agents, Nonsteroidal Abortifacient Agents Reproductive Control Agents	Physiological Effects of Drugs Antimetabolites, Antineoplastic Antimetabolites Molecular Mechanisms of Pharmacological Action Dermatologic Agents Enzyme Inhibitors Folic Acid Antagonists Immunosuppressive Agents Immunologic Factors Antirheumatic Agents Nucleic Acid Synthesis Inhibitors Antibiotics, Antineoplastic Topoisomerase II Inhibitors Topoisomerase Inhibitors

ClinicalTrials.gov processed this record on July 27, 2017

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