Ignite Creation Date:
2024-05-05 @ 11:07 AM
Last Modification Date:
2024-10-26 @ 9:03 AM
Study NCT ID:
NCT00002492
Status:
COMPLETED
Last Update Posted:
2016-12-15
First Post:
1999-11-01
Brief Title:
Combination Chemotherapy in Treating Patients With Soft Tissue Sarcoma
Sponsor:
University of Miami
Organization:
University of Miami
Study Overview
Official Title:
CLINICAL AND PHARMACOLOGICAL STUDY OF CHEMOTHERAPY IN SOFT TISSUE SARCOMA
Status:
COMPLETED
Status Verified Date:
2016-12
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
PURPOSE Phase II trial to study the effectiveness of combining cisplatin and doxorubicin in treating patients who have soft tissue sarcoma
PURPOSE Phase II trial to study the effectiveness of combining cisplatin and doxorubicin in treating patients who have soft tissue sarcoma
Detailed Description:
OBJECTIVES I Determine the response in patients with resectable soft tissue sarcoma of the extremity treated with neoadjuvant intra-arterial cisplatin and IV doxorubicin followed by limb-sparing procedure or amputation adjuvant IV cisplatin and IV doxorubicin and radiotherapy II Determine the chemotherapeutic response in tumor specimens of patients treated with this regimen
OUTLINE Neoadjuvant chemotherapy Patients undergo arterial cannulation followed by cisplatin intra-arterially over 4 hours on day 1 and doxorubicin IV beginning 15 minutes after completion of cisplatin infusion on days 1-3 Treatment continues every 3 weeks for 2 courses in the absence of unacceptable toxicity Patients undergo amputation or limb-sparing wide excision as feasible approximately 4 weeks after the second course If surgery cannot be scheduled at this time for logistical reasons a third course may be administered Patients with an estimated tumor kill of at least 50 receive adjuvant chemotherapy as outlined below Patients undergoing limb-sparing wide excision receive post-operative radiotherapy as outlined below Adjuvant chemotherapy Beginning 3-4 weeks after surgery patients receive cisplatin IV over 4 hours on day 1 and doxorubicin as above on days 1-3 Treatment continues every 3 weeks for 4 courses in the absence of disease progression stable disease or unacceptable toxicity Patients undergoing radiotherapy receive the final 3 courses of chemotherapy after completion of radiotherapy Post-operative radiotherapy Beginning after the first postoperative chemotherapy course and within 8 weeks after surgery patients receive radiotherapy 5 days a week for 7-8 weeks An interstitial implant using iridium Ir 192 may be used to administer the final doses of radiotherapy
PROJECTED ACCRUAL A total of 40 patients will be accrued for this study within 4 years
OUTLINE Neoadjuvant chemotherapy Patients undergo arterial cannulation followed by cisplatin intra-arterially over 4 hours on day 1 and doxorubicin IV beginning 15 minutes after completion of cisplatin infusion on days 1-3 Treatment continues every 3 weeks for 2 courses in the absence of unacceptable toxicity Patients undergo amputation or limb-sparing wide excision as feasible approximately 4 weeks after the second course If surgery cannot be scheduled at this time for logistical reasons a third course may be administered Patients with an estimated tumor kill of at least 50 receive adjuvant chemotherapy as outlined below Patients undergoing limb-sparing wide excision receive post-operative radiotherapy as outlined below Adjuvant chemotherapy Beginning 3-4 weeks after surgery patients receive cisplatin IV over 4 hours on day 1 and doxorubicin as above on days 1-3 Treatment continues every 3 weeks for 4 courses in the absence of disease progression stable disease or unacceptable toxicity Patients undergoing radiotherapy receive the final 3 courses of chemotherapy after completion of radiotherapy Post-operative radiotherapy Beginning after the first postoperative chemotherapy course and within 8 weeks after surgery patients receive radiotherapy 5 days a week for 7-8 weeks An interstitial implant using iridium Ir 192 may be used to administer the final doses of radiotherapy
PROJECTED ACCRUAL A total of 40 patients will be accrued for this study within 4 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-V92-0066 | Other Identifier | University of Miami Sylvester Comprehensive Cancer Center | None |
| SCCC-1989032 | OTHER | None | None |