Ignite Creation Date:
2024-05-05 @ 11:21 AM
Last Modification Date:
2024-10-26 @ 9:05 AM
Study NCT ID:
NCT00005974
Status:
COMPLETED
Last Update Posted:
2020-04-08
First Post:
2000-07-05
Brief Title:
Flavopiridol in Treating Patients With Recurrent Locally Advanced or Metastatic Soft Tissue Sarcoma
Sponsor:
NCIC Clinical Trials Group
Organization:
Canadian Cancer Trials Group
Study Overview
Official Title:
A Phase II Study of Flavopiridol HMR 1275 NSC 649890 in Patients With Previously Untreated Metastatic or Locally Advanced Soft Tissue Sarcoma
Status:
COMPLETED
Status Verified Date:
2020-04
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
PURPOSE Phase II trial to study the effectiveness of flavopiridol in treating patients who have recurrent locally advanced or metastatic soft tissue sarcoma
PURPOSE Phase II trial to study the effectiveness of flavopiridol in treating patients who have recurrent locally advanced or metastatic soft tissue sarcoma
Detailed Description:
OBJECTIVES I Determine the efficacy of flavopiridol in terms of response rate in patients with previously untreated metastatic or locally advanced soft tissue sarcoma II Determine the toxicity of this regimen in these patients III Determine the time to progression early progression rate and response duration in patients treated with this regimen
OUTLINE This is a multicenter study Patients receive flavopiridol IV over 1 hour daily on days 1-3 Treatment continues every 3 weeks in the absence of disease progression or unacceptable toxicity Patients are followed at 4 weeks and then every 3 months until disease progression or death
PROJECTED ACCRUAL A total of 15-30 patients will be accrued for this study over 12-18 months
OUTLINE This is a multicenter study Patients receive flavopiridol IV over 1 hour daily on days 1-3 Treatment continues every 3 weeks in the absence of disease progression or unacceptable toxicity Patients are followed at 4 weeks and then every 3 months until disease progression or death
PROJECTED ACCRUAL A total of 15-30 patients will be accrued for this study over 12-18 months
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
True
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| CDR0000067961 | OTHER | PDQ | None |
| CAN-NCIC-IND136 | OTHER | None | None |
| NCI-NCIC-136 | OTHER | None | None |