Ignite Creation Date:
2024-05-05 @ 9:53 AM
Last Modification Date:
2024-10-26 @ 9:03 AM
Study NCT ID:
NCT00003549
Status:
COMPLETED
Last Update Posted:
2012-10-08
First Post:
1999-11-01
Brief Title:
S9716 Combination Chemotherapy in Treating Patients With Merkel Cell Cancer
Sponsor:
SWOG Cancer Research Network
Organization:
SWOG Cancer Research Network
Study Overview
Official Title:
A Phase II Trial of Cyclophosphamide Methotrexate and 5-Fluorouracil CMF in Neuroendocrine Carcinoma of the Skin Merkel Cell Carcinoma
Status:
COMPLETED
Status Verified Date:
2012-10
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 Combining more than one drug may kill more tumor cells
PURPOSE Phase II trial to study the effectiveness of combining cyclophosphamide methotrexate and fluorouracil in treating patients with Merkel cell cancer
PURPOSE Phase II trial to study the effectiveness of combining cyclophosphamide methotrexate and fluorouracil in treating patients with Merkel cell cancer
Detailed Description:
OBJECTIVES I Investigate the ability of the Southwest Oncology Group Melanoma Committee to enroll patients with unresectable Merkel cell carcinoma that is local-regional or metastatic II Determine the overall survival rate and objective response rate of these patients after treatment with cyclophosphamide methotrexate and fluorouracil
OUTLINE Patients are stratified according to local-regional disease versus metastatic disease Patients receive cyclophosphamide IV methotrexate IV and fluorouracil IV on day 1 Courses repeat every 21 days for up to 2 years in the absence of disease progression or unacceptable toxicities Patients are followed every 6 months for 2 years then annually thereafter
PROJECTED ACCRUAL A total of 80 patients 40 patients per stratum will be accrued for this study
OUTLINE Patients are stratified according to local-regional disease versus metastatic disease Patients receive cyclophosphamide IV methotrexate IV and fluorouracil IV on day 1 Courses repeat every 21 days for up to 2 years in the absence of disease progression or unacceptable toxicities Patients are followed every 6 months for 2 years then annually thereafter
PROJECTED ACCRUAL A total of 80 patients 40 patients per stratum will be accrued for this study
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 |
|---|---|---|---|
| S9716 | OTHER | SWOG | httpsreporternihgovquickSearchU10CA032102 |
| U10CA032102 | NIH | None | None |