Phase II Study of Chemotherapy and Pamidronate for the Treatment of Newly Diagnosed Osteosarcoma
This study has been completed.
Sponsor:
Memorial Sloan Kettering Cancer Center
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
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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:
Drug Information available for:
Methotrexate
Methotrexate sodium
Cisplatin
Doxorubicin
Doxorubicin hydrochloride
Genetic and Rare Diseases Information Center resources:
Bone Cancer
Osteosarcoma
Malignant Mesenchymal Tumor
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 ] [ Designated as safety issue: No ]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 |
| 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
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:
| 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 |
| 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, 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 September 28, 2016