Ignite Creation Date:
2024-05-05 @ 11:47 AM
Last Modification Date:
2024-10-26 @ 9:13 AM
Study NCT ID:
NCT00134641
Status:
COMPLETED
Last Update Posted:
2007-12-21
First Post:
2005-08-24
Brief Title:
Study of Gemcitabine and Vinorelbine in Soft Tissue Sarcomas
Sponsor:
Dana-Farber Cancer Institute
Organization:
Dana-Farber Cancer Institute
Study Overview
Official Title:
A Phase II Study Evaluating Efficacy of the Combination of Gemcitabine and Vinorelbine in Advanced Soft Tissue Sarcoma
Status:
COMPLETED
Status Verified Date:
2007-12
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:
The purpose of this study is to determine if the combination of gemcitabine and vinorelbine is effective in treating patients with advanced soft tissue sarcoma
Detailed Description:
Patients will receive both gemcitabine and vinorelbine once a week for two weeks and then one week with no chemotherapy 1 cycle equals 21 days Gemcitabine and vinorelbine will be administered on day 1 and day 8 of each cycle
Blood tests will be performed on each day chemotherapy is administered A CT scan will be done after every 2 cycles approximately every 6 weeks to determine the effects of the chemotherapy on the sarcoma
A physical exam will be performed at the start of chemotherapy and at least every three weeks thereafter
Patients will remain on this study as long as the disease does not progress or there are no unacceptable side effects
Blood tests will be performed on each day chemotherapy is administered A CT scan will be done after every 2 cycles approximately every 6 weeks to determine the effects of the chemotherapy on the sarcoma
A physical exam will be performed at the start of chemotherapy and at least every three weeks thereafter
Patients will remain on this study as long as the disease does not progress or there are no unacceptable side effects
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