Ignite Creation Date:
2024-05-05 @ 11:23 AM
Last Modification Date:
2024-10-26 @ 9:06 AM
Study NCT ID:
NCT00019864
Status:
TERMINATED
Last Update Posted:
2015-06-08
First Post:
2001-07-11
Brief Title:
Combination Chemotherapy Before and After Surgery in Treating Patients With Osteosarcoma
Sponsor:
National Cancer Institute NCI
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
Osteosarcoma Outcome of Therapy Based on Histologic Response A Collaborative Effort of the POBNCI Texas Childrens Hospital and University of Oklahoma
Status:
TERMINATED
Status Verified Date:
2007-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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
PURPOSE This phase II trial is studying how well giving chemotherapy before and after surgery works in treating patients with osteosarcoma
Detailed Description:
OBJECTIVES
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
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 Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?:
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| NCI-99-C-0125I | None | None | None |