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

This study has been completed.
Sponsor:
Information provided by:
Memorial Sloan-Kettering Cancer Center
ClinicalTrials.gov Identifier:
NCT00586846
First received: December 21, 2007
Last updated: February 12, 2009
Last verified: February 2009
  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: Endpoint Classification: Safety Study
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:


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
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/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 < 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:
No publications provided

Responsible Party: Paul Meyers, 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
Last Updated: February 12, 2009
Health Authority: United States: Food and Drug Administration

Keywords provided by Memorial Sloan-Kettering Cancer Center:
Cisplatin
Doxorubicin
Methotrexate
Osteosarcoma
03-074

Additional relevant MeSH terms:
Osteosarcoma
Neoplasms
Neoplasms by Histologic Type
Neoplasms, Bone Tissue
Neoplasms, Connective Tissue
Neoplasms, Connective and Soft Tissue
Sarcoma
Cisplatin
Doxorubicin
Liposomal doxorubicin
Methotrexate
Abortifacient Agents
Abortifacient Agents, Nonsteroidal
Antibiotics, Antineoplastic
Antimetabolites
Antimetabolites, Antineoplastic
Antineoplastic Agents
Antirheumatic Agents
Dermatologic Agents
Enzyme Inhibitors
Folic Acid Antagonists
Immunologic Factors
Immunosuppressive Agents
Molecular Mechanisms of Pharmacological Action
Nucleic Acid Synthesis Inhibitors
Pharmacologic Actions
Physiological Effects of Drugs
Radiation-Sensitizing Agents
Reproductive Control Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on November 24, 2014