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| Sponsors and Collaborators: |
Memorial Sloan-Kettering Cancer Center National Cancer Institute (NCI) |
| Information provided by: | National Cancer Institute (NCI) |
| ClinicalTrials.gov Identifier: | NCT00072306 |
Purpose
RATIONALE: Drugs used in chemotherapy, such as cisplatin, doxorubicin, and methotrexate, work in different ways to stop tumor cells from dividing so they stop growing or die. Combining pamidronate with chemotherapy may prevent bone metastases and reduce the chance of bone replacement problems by strengthening bones in patients who are undergoing surgery for osteosarcoma.
PURPOSE: Phase II trial to study the effectiveness of combining neoadjuvant and adjuvant pamidronate with induction and maintenance chemotherapy in treating patients who have newly diagnosed osteosarcoma.
| Condition | Intervention | Phase |
|
Sarcoma |
Drug: cisplatin Drug: doxorubicin hydrochloride Drug: methotrexate Drug: pamidronate disodium Procedure: adjuvant therapy Procedure: conventional surgery Procedure: neoadjuvant therapy |
Phase II |
| MedlinePlus related topics: | Cancer Soft Tissue Sarcoma |
| Drug Information available for: | Doxorubicin Doxorubicin hydrochloride Cisplatin Methotrexate Pamidronate disodium Amidronate |
| Study Type: | Interventional |
| Study Design: | Treatment, Open Label |
| Official Title: | A Phase II Study of Chemotherapy and Pamidronate for the Treatment of Newly Diagnosed Osteosarcoma |
| Estimated Enrollment: | 75 |
| Study Start Date: | July 2003 |
OBJECTIVES:
OUTLINE: Patients are stratified according to extent of disease (localized vs metastatic).
NOTE: *Patients who have undergone definitive surgical resection before study entry may proceed to maintenance therapy or, if appropriate, surgical resection of metastatic disease
Patients are followed monthly for 1 year.
PROJECTED ACCRUAL: A total of 75 patients (50 with localized disease; 25 with metastatic disease) will be accrued for this study within 3-4 years.
Eligibility
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically confirmed high-grade osteosarcoma
Previously untreated
PATIENT CHARACTERISTICS:
Age
Performance status
Life expectancy
Hematopoietic
Hepatic
Renal
Cardiovascular
Other
PRIOR CONCURRENT THERAPY:
Biologic therapy
Chemotherapy
Endocrine therapy
Radiotherapy
Surgery
Other
Contacts and Locations| United States, New York | |||||
| Memorial Sloan-Kettering Cancer Center | |||||
| New York, New York, United States, 10021 | |||||
| Memorial Sloan-Kettering Cancer Center |
| National Cancer Institute (NCI) |
| Principal Investigator: | Paul A. Meyers, MD | Memorial Sloan-Kettering Cancer Center |
More Information
Clinical trial summary from the National Cancer Institute's PDQ® database 
  |
| Study ID Numbers: | CDR0000339591, MSKCC-03074 |
| First Received: | November 4, 2003 |
| Last Updated: | June 21, 2008 |
| ClinicalTrials.gov Identifier: | NCT00072306 |
| Health Authority: | United States: Federal Government |
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