Ignite Creation Date:
2024-05-05 @ 11:24 AM
Last Modification Date:
2024-10-26 @ 9:06 AM
Study NCT ID:
NCT00023998
Status:
COMPLETED
Last Update Posted:
2013-02-04
First Post:
2001-09-13
Brief Title:
Chemotherapy With or Without Trastuzumab in Treating Patients With Metastatic Osteosarcoma
Sponsor:
National Cancer Institute NCI
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
A Groupwide Phase II Study of Trastuzumab Herceptin in Metastatic Osteosarcoma Patients With Tumors That Overexpress HER2
Status:
COMPLETED
Status Verified Date:
2013-01
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:
Drugs used in chemotherapy work in different ways to stop tumor cells from dividing so they stop growing or die Monoclonal antibodies such as trastuzumab can locate tumor cells and kill them without harming normal cells Combining monoclonal antibody therapy with chemotherapy may kill more tumor cells Phase II trial to study the effectiveness of chemotherapy with or without trastuzumab in treating patients who have metastatic osteosarcoma
Detailed Description:
PRIMARY OBJECTIVES
I Determine the feasibility and safety of trastuzumab Herceptin and chemotherapy in patients with HER2-overexpressing 2 level of expression metastatic osteosarcoma
II Determine the response rate and 3-year event-free survival of patients treated with this regimen
III Determine the cardiac toxicity and late effects of this regimen in these patients
IV Determine the response rate and 3-year event-free survival of poor-risk patients with HER2-negative tumors treated with chemotherapy without the addition of trastuzumab
OUTLINE This is a multicenter study Patients are stratified according to tumor HER2 status positive vs negative
Patients receive induction therapy comprising doxorubicin IV over 20 minutes followed by cisplatin IV over 4 hours on days 1 and 2 of weeks 1 and 6 and methotrexate IV over 4 hours on day 1 of weeks 4 5 9 and 10 Patients also receive leucovorin calcium IV or orally every 6 hours beginning 24 hours after each methotrexate dose and continuing for at least 10 doses until methotrexate levels sufficiently decrease Within 24-36 hours after completion of induction therapy patients receive filgrastim G-CSF daily until blood counts recover
Patients undergo resection of any remaining primary tumor andor metastatic lesions during week 11 Patients who are unable to undergo resection receive radiotherapy between weeks 11 and 17
Patients receive post-induction therapy comprising doxorubicin IV over 20 minutes on days 1 and 2 of weeks 17 25 and 29 cisplatin IV over 4 hours on days 1 and 2 of weeks 17 and 25 methotrexate IV over 4 hours on day 1 of weeks 16 20 24 28 32 and 33 etoposide IV over 1 hour on days 1-5 of weeks 13 21 and 34 and ifosfamide IV over 4 hours on days 1-5 of weeks 13 21 29 and 34 Patients also receive leucovorin calcium and G-CSF as in induction therapy Patients whose tumors are found to over express HER2 2 level of expression also receive trastuzumab IV over 30-90 minutes once a week for a total of 34 weeks in addition to the chemotherapy regimen
Patients are followed monthly for 1 year every 2 months for 1 year every 6 months for 2 years and then annually thereafter
PROJECTED ACCRUAL A total of 80 patients 40 patients per stratum will be accrued for this study within 25 years
I Determine the feasibility and safety of trastuzumab Herceptin and chemotherapy in patients with HER2-overexpressing 2 level of expression metastatic osteosarcoma
II Determine the response rate and 3-year event-free survival of patients treated with this regimen
III Determine the cardiac toxicity and late effects of this regimen in these patients
IV Determine the response rate and 3-year event-free survival of poor-risk patients with HER2-negative tumors treated with chemotherapy without the addition of trastuzumab
OUTLINE This is a multicenter study Patients are stratified according to tumor HER2 status positive vs negative
Patients receive induction therapy comprising doxorubicin IV over 20 minutes followed by cisplatin IV over 4 hours on days 1 and 2 of weeks 1 and 6 and methotrexate IV over 4 hours on day 1 of weeks 4 5 9 and 10 Patients also receive leucovorin calcium IV or orally every 6 hours beginning 24 hours after each methotrexate dose and continuing for at least 10 doses until methotrexate levels sufficiently decrease Within 24-36 hours after completion of induction therapy patients receive filgrastim G-CSF daily until blood counts recover
Patients undergo resection of any remaining primary tumor andor metastatic lesions during week 11 Patients who are unable to undergo resection receive radiotherapy between weeks 11 and 17
Patients receive post-induction therapy comprising doxorubicin IV over 20 minutes on days 1 and 2 of weeks 17 25 and 29 cisplatin IV over 4 hours on days 1 and 2 of weeks 17 and 25 methotrexate IV over 4 hours on day 1 of weeks 16 20 24 28 32 and 33 etoposide IV over 1 hour on days 1-5 of weeks 13 21 and 34 and ifosfamide IV over 4 hours on days 1-5 of weeks 13 21 29 and 34 Patients also receive leucovorin calcium and G-CSF as in induction therapy Patients whose tumors are found to over express HER2 2 level of expression also receive trastuzumab IV over 30-90 minutes once a week for a total of 34 weeks in addition to the chemotherapy regimen
Patients are followed monthly for 1 year every 2 months for 1 year every 6 months for 2 years and then annually thereafter
PROJECTED ACCRUAL A total of 80 patients 40 patients per stratum will be accrued for this study within 25 years
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| CDR0000068882 | REGISTRY | PDQ Physician Data Query | httpsreporternihgovquickSearchU10CA098543 |
| AOST0121 | None | None | None |
| U10CA098543 | NIH | None | None |