Combination Chemotherapy Before and After Surgery in Treating Patients With Osteosarcoma
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00019864|
Recruitment Status : Terminated
First Posted : January 27, 2003
Last Update Posted : June 8, 2015
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Giving chemotherapy before surgery may shrink the tumor so that it can be removed during surgery. Giving chemotherapy after surgery may kill more tumor cells.
PURPOSE: This phase II trial is studying how well giving chemotherapy before and after surgery works in treating patients with osteosarcoma.
|Condition or disease||Intervention/treatment||Phase|
|Cardiac Toxicity Sarcoma||Biological: filgrastim Drug: cisplatin Drug: dexrazoxane hydrochloride Drug: doxorubicin hydrochloride Drug: leucovorin calcium Drug: methotrexate Procedure: adjuvant therapy Procedure: conventional surgery Procedure: neoadjuvant therapy||Phase 2|
- Determine the rate of in vivo histologic response in patients with osteosarcoma treated with neoadjuvant cisplatin, methotrexate, and doxorubicin with dexrazoxane (as cardioprotection).
- Determine the event-free and overall survival of patients with nonmetastatic disease who show good response to neoadjuvant therapy and receive adjuvant therapy with the same regimen.
- Determine the event-free survival of patients with nonmetastatic disease who show poor response to neoadjuvant therapy and receive adjuvant therapy with the same regimen.
- Determine the event-free survival and overall survival of patients with metastatic disease who receive neoadjuvant therapy.
OUTLINE: This is a multicenter study.
- Neoadjuvant therapy: Patients receive neoadjuvant chemotherapy comprising dexrazoxane IV over 15 minutes, doxorubicin IV over 15 minutes, and cisplatin IV over 4 hours on days 1 and 2 in week 0. Patients also receive methotrexate IV over 4 hours followed by leucovorin calcium in weeks 3 and 4. Patients then receive filgrastim (G-CSF) subcutaneously (SC) once daily beginning 24 hours after completion of chemotherapy and continuing until blood counts recover. Treatment repeats every 5 weeks for 2 courses in the absence of disease progression or unacceptable toxicity.
- Surgical resection: Patients undergo definitive surgery in week 11.
- Adjuvant therapy: Patients receive dexrazoxane, doxorubicin, cisplatin, methotrexate, and leucovorin calcium as in neoadjuvant therapy*. Treatment repeats every 5 weeks for up to 4 courses in the absence of disease progression or unacceptable toxicity.
NOTE: *Cisplatin is not administered in courses 3 and 4 of adjuvant therapy
Patients are followed within 4 weeks, every 3 months for 2 years, every 6 months for 2 years, and then annually thereafter.
PROJECTED ACCRUAL: Approximately 100 patients will be accrued for this study.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||100 participants|
|Masking:||None (Open Label)|
|Official Title:||Osteosarcoma: Outcome of Therapy Based on Histologic Response. A Collaborative Effort of the POB/NCI, Texas Children's Hospital and University of Oklahoma.|
|Study Start Date :||March 2000|
|Actual Primary Completion Date :||December 2006|
|Actual Study Completion Date :||October 2011|
- Rate of in vivo histologic response
- Event-free survival
- Overall survival
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00019864
|United States, Maryland|
|Warren Grant Magnuson Clinical Center - NCI Clinical Trials Referral Office|
|Bethesda, Maryland, United States, 20892-1182|
|United States, Oklahoma|
|Oklahoma University Cancer Institute|
|Oklahoma City, Oklahoma, United States, 73104|
|United States, Texas|
|Cook Children's Medical Center - Fort Worth|
|Fort Worth, Texas, United States, 76104|
|Texas Children's Cancer Center and Hematology Service at Texas Children's Hospital|
|Houston, Texas, United States, 77030-2399|
|Study Chair:||Ramzi Dagher, MD||National Cancer Institute (NCI)|