Ignite Creation Date:
2024-05-05 @ 11:08 AM
Last Modification Date:
2024-10-26 @ 9:04 AM
Study NCT ID:
NCT00003776
Status:
COMPLETED
Last Update Posted:
2013-06-21
First Post:
1999-11-01
Brief Title:
Combination Chemotherapy and Surgery in Treating Patients With Newly Diagnosed Metastatic Osteosarcoma
Sponsor:
Memorial Sloan Kettering Cancer Center
Organization:
Memorial Sloan Kettering Cancer Center
Study Overview
Official Title:
A Phase II Window Study of Trimetrexate With Simultaneous Leucovorin Protection in the Treatment of Newly Diagnosed Patients With Metastatic Osteosarcoma
Status:
COMPLETED
Status Verified Date:
2013-06
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 Combining more than one drug or combining chemotherapy with surgery may kill more tumor cells
PURPOSE Phase II trial to study the effectiveness of combination chemotherapy and surgery in treating patients who have newly diagnosed metastatic osteosarcoma
PURPOSE Phase II trial to study the effectiveness of combination chemotherapy and surgery in treating patients who have newly diagnosed metastatic osteosarcoma
Detailed Description:
OBJECTIVES I Determine the efficacy of oral trimetrexate glucuronate with simultaneous leucovorin calcium protection in patients with newly diagnosed metastatic osteogenic sarcoma II Evaluate the toxicity of this regimen when administered prior to and following standard chemotherapy in patients with osteogenic sarcoma III Correlate response with in vitro determinants of chemotherapy resistance in tumor samples obtained from these patients
OUTLINE Patients receive induction therapy of oral trimetrexate glucuronate TMTX and leucovorin calcium every 12 hours for 21 days weeks 0-2 Patients receive leucovorin calcium for 3 additional days after the last dose of TMTX If age prevents compliance with oral administration patients receive TMTX IV and leucovorin calcium IV Patients undergo definitive surgery 7-10 days after the induction therapy week 4 Patients undergo surgery for metastatic disease if indicated as soon as possible following recovery from definitive surgery Patients then receive maintenance therapy every 3 weeks for 8-9 months according to the following schedule Patients receive ifosfamide IV over 1 hour 4 times daily on days 1-4 plus doxorubicin IV over 48 hours on days 1-2 in weeks 6 14 and 22 and ifosfamide alone in week 30 Patients receive cisplatin IV over 4 hours for 1 day plus doxorubicin IV over 48 hours for 2 days beginning on the same day as the first dose of cisplatin in weeks 10 18 and 26 Patients receive cisplatin alone in week 34 Patients receive filgrastim subcutaneously daily for 2 weeks starting 24 hours after the completion of each course of ifosfamide and cisplatin therapy Patients receive methotrexate IV over 4 hours for 1 day plus oral leucovorin calcium every 6 hours for at least 10 doses beginning 20 hours after the last dose of methotrexate in weeks 9 13 17 21 25 29 33 and 37 In severe cases patients receive leucovorin calcium IV over 24 hours Patients who respond to induction therapy receive a second course of the same therapy in weeks 38-40 Patients are followed every 4 months for 1 year then every 6 months for 2 years
PROJECTED ACCRUAL A total of 18-33 patients will be accrued for this study over 2-3 years
OUTLINE Patients receive induction therapy of oral trimetrexate glucuronate TMTX and leucovorin calcium every 12 hours for 21 days weeks 0-2 Patients receive leucovorin calcium for 3 additional days after the last dose of TMTX If age prevents compliance with oral administration patients receive TMTX IV and leucovorin calcium IV Patients undergo definitive surgery 7-10 days after the induction therapy week 4 Patients undergo surgery for metastatic disease if indicated as soon as possible following recovery from definitive surgery Patients then receive maintenance therapy every 3 weeks for 8-9 months according to the following schedule Patients receive ifosfamide IV over 1 hour 4 times daily on days 1-4 plus doxorubicin IV over 48 hours on days 1-2 in weeks 6 14 and 22 and ifosfamide alone in week 30 Patients receive cisplatin IV over 4 hours for 1 day plus doxorubicin IV over 48 hours for 2 days beginning on the same day as the first dose of cisplatin in weeks 10 18 and 26 Patients receive cisplatin alone in week 34 Patients receive filgrastim subcutaneously daily for 2 weeks starting 24 hours after the completion of each course of ifosfamide and cisplatin therapy Patients receive methotrexate IV over 4 hours for 1 day plus oral leucovorin calcium every 6 hours for at least 10 doses beginning 20 hours after the last dose of methotrexate in weeks 9 13 17 21 25 29 33 and 37 In severe cases patients receive leucovorin calcium IV over 24 hours Patients who respond to induction therapy receive a second course of the same therapy in weeks 38-40 Patients are followed every 4 months for 1 year then every 6 months for 2 years
PROJECTED ACCRUAL A total of 18-33 patients will be accrued for this study over 2-3 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 |
|---|---|---|---|
| NCI-G99-1507 | Registry Identifier | PDQ Physician Data Query | None |
| CDR0000066905 | REGISTRY | None | None |