Ignite Creation Date:
2024-05-05 @ 11:20 AM
Last Modification Date:
2024-10-26 @ 9:04 AM
Study NCT ID:
NCT00003937
Status:
COMPLETED
Last Update Posted:
2014-08-05
First Post:
1999-11-01
Brief Title:
Combination Chemotherapy Plus Dexrazoxane in Treating Patients With Newly Diagnosed Nonmetastatic Osteosarcoma
Sponsor:
Childrens Oncology Group
Organization:
Childrens Oncology Group
Study Overview
Official Title:
Protocol for Patients With Newly-Diagnosed Non-Metastatic Osteosarcoma - A POGCCG Pilot Intergroup Study
Status:
COMPLETED
Status Verified Date:
2014-08
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 may kill more tumor cells Chemoprotective drugs such as dexrazoxane may protect normal cells from the side effects of chemotherapy
PURPOSE Phase III trial to study the effectiveness of three combination chemotherapy regimens plus dexrazoxane in treating patients who have newly diagnosed nonmetastatic osteosarcoma
PURPOSE Phase III trial to study the effectiveness of three combination chemotherapy regimens plus dexrazoxane in treating patients who have newly diagnosed nonmetastatic osteosarcoma
Detailed Description:
OBJECTIVES I Compare the efficacy of three intensification regimens doxorubicin vs doxorubicin plus ifosfamide vs doxorubicin plus ifosfamide and etoposide in patients with newly diagnosed previously untreated nonmetastatic osteosarcoma II Determine the effect of postoperative dose intensification on outcome in patients with standard response to preoperative chemotherapy III Determine the effect of dexrazoxane cardioprotection during standard induction therapy on histologic response in these patients IV Evaluate biological factors that may predict outcome in these patients V Determine the safety of dexrazoxane administered with doxorubicin in combination with cisplatin or cisplatin and ifosfamide in these patients VI Determine the effect of dexrazoxane on cytotoxicity as measured by tumor necrosis at definitive surgery in these patients VII Assess the feasibility of administering doxorubicin with dexrazoxane cardioprotection or high dose ifosfamide with etoposide to standard risk patients who are also receiving methotrexate and cisplatin
OUTLINE This is a multicenter study Patients are enrolled sequentially on 1 of 3 pilot intensification regimens After surgery to completely remove the primary tumor patients are assigned to 1 of 2 adjuvant chemotherapy groups based on percent necrosis at limb salvage Pilot 1 Closed to accrual as of 622000 Patients receive dexrazoxane IV followed immediately by doxorubicin IV over 20 minutes plus cisplatin IV over 4 hours on days 1 and 2 of weeks 1 and 6 Methotrexate IV over 4 hours is administered on day 1 of weeks 4 5 9 and 10 Patients undergo surgery on week 11 Adjuvant chemotherapy begins on day 1 of week 13 Group 1 good response to neoadjuvant chemotherapy Patients receive methotrexate IV over 4 hours every 3 weeks for 6 courses beginning on week 13 Patients also receive dexrazoxane and doxorubicin every 3 weeks for 4 courses beginning on week 14 Cisplatin is administered with the first 2 courses of dexrazoxane and doxorubicin Group 2 standard response to neoadjuvant chemotherapy Patients receive methotrexate and cisplatin as in group 1 plus dexrazoxane and doxorubicin for 6 courses Pilot 2 Patients receive preoperative therapy comprised of dexrazoxane doxorubicin and methotrexate as in pilot 1 Ifosfamide IV over 4 hours is also administered on days 1-5 of week 1 Patients undergo surgery on week 11 then begin adjuvant chemotherapy on week 13 Group 1 Patients receive methotrexate dexrazoxane and doxorubicin as in pilot 1 group 1 Ifosfamide is also administered on weeks 14 and 20 Cisplatin is administered on weeks 17 23 and 26 Group 2 Patients receive methotrexate dexrazoxane and doxorubicin as in pilot 1 group 2 Ifosfamide is administered on weeks 14 20 26 and 31 Cisplatin is administered on weeks 17 23 and 29 Pilot 3 Open to accrual as of 622000 Patients receive preoperative therapy comprised of methotrexate dexrazoxane doxorubicin ifosfamide and cisplatin as in pilot 2 Patients undergo surgery on week 11 then begin adjuvant chemotherapy on week 13 Group 1 Patients receive methotrexate dexrazoxane doxorubicin ifosfamide and cisplatin as in pilot 2 group 1 Group 2 Patients receive methotrexate on weeks 13 19 29 32 35 and 36 high dose ifosfamide and etoposide IV over 4 hours on days 1-5 of weeks 14 23 and 26 and cisplatin on weeks 20 30 and 33 Dexrazoxane and doxorubicin are administered on weeks 17 20 30 and 33 Patients are followed every 3 months for 1 year every 6 months for 4 years and then annually thereafter
PROJECTED ACCRUAL Approximately 180 patients will be accrued for this study within 2 years
OUTLINE This is a multicenter study Patients are enrolled sequentially on 1 of 3 pilot intensification regimens After surgery to completely remove the primary tumor patients are assigned to 1 of 2 adjuvant chemotherapy groups based on percent necrosis at limb salvage Pilot 1 Closed to accrual as of 622000 Patients receive dexrazoxane IV followed immediately by doxorubicin IV over 20 minutes plus cisplatin IV over 4 hours on days 1 and 2 of weeks 1 and 6 Methotrexate IV over 4 hours is administered on day 1 of weeks 4 5 9 and 10 Patients undergo surgery on week 11 Adjuvant chemotherapy begins on day 1 of week 13 Group 1 good response to neoadjuvant chemotherapy Patients receive methotrexate IV over 4 hours every 3 weeks for 6 courses beginning on week 13 Patients also receive dexrazoxane and doxorubicin every 3 weeks for 4 courses beginning on week 14 Cisplatin is administered with the first 2 courses of dexrazoxane and doxorubicin Group 2 standard response to neoadjuvant chemotherapy Patients receive methotrexate and cisplatin as in group 1 plus dexrazoxane and doxorubicin for 6 courses Pilot 2 Patients receive preoperative therapy comprised of dexrazoxane doxorubicin and methotrexate as in pilot 1 Ifosfamide IV over 4 hours is also administered on days 1-5 of week 1 Patients undergo surgery on week 11 then begin adjuvant chemotherapy on week 13 Group 1 Patients receive methotrexate dexrazoxane and doxorubicin as in pilot 1 group 1 Ifosfamide is also administered on weeks 14 and 20 Cisplatin is administered on weeks 17 23 and 26 Group 2 Patients receive methotrexate dexrazoxane and doxorubicin as in pilot 1 group 2 Ifosfamide is administered on weeks 14 20 26 and 31 Cisplatin is administered on weeks 17 23 and 29 Pilot 3 Open to accrual as of 622000 Patients receive preoperative therapy comprised of methotrexate dexrazoxane doxorubicin ifosfamide and cisplatin as in pilot 2 Patients undergo surgery on week 11 then begin adjuvant chemotherapy on week 13 Group 1 Patients receive methotrexate dexrazoxane doxorubicin ifosfamide and cisplatin as in pilot 2 group 1 Group 2 Patients receive methotrexate on weeks 13 19 29 32 35 and 36 high dose ifosfamide and etoposide IV over 4 hours on days 1-5 of weeks 14 23 and 26 and cisplatin on weeks 20 30 and 33 Dexrazoxane and doxorubicin are administered on weeks 17 20 30 and 33 Patients are followed every 3 months for 1 year every 6 months for 4 years and then annually thereafter
PROJECTED ACCRUAL Approximately 180 patients will be accrued for this study within 2 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 |
|---|---|---|---|
| CDR0000067129 | OTHER | Clinical Trialsgov | None |
| COG-P9754 | OTHER | None | None |
| POG-P9754 | OTHER | None | None |
| CCG-P9754 | OTHER | None | None |