Ignite Creation Date:
2024-05-05 @ 12:02 PM
Last Modification Date:
2024-10-26 @ 9:19 AM
Study NCT ID:
NCT00226941
Status:
TERMINATED
Last Update Posted:
2017-12-08
First Post:
2005-09-08
Brief Title:
A Phase 1-2 Trial of Cetuximab in Combination With Oxaliplatin Capecitabine and Radiation Therapy Followed by Surgery for Locally-advanced Rectal Cancer
Sponsor:
George Albert Fisher
Organization:
Stanford University
Study Overview
Official Title:
A Phase 1-2 Trial of Cetuximab in Combination With Oxaliplatin Capecitabine and Radiation Therapy Followed by Surgical Resection for Locally-Advanced Rectal Cancer
Status:
TERMINATED
Status Verified Date:
2017-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
The response rate observed in the phase 1 portion of the study did not merit further evaluation in phase 2 portion of the study
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The objectives of this study are to
1 To assess dose-limiting toxicities DLTs of capecitabine - oxaliplatin in a combination regimen with capecitabine and radiotherapy Phase 1
2 To determine the maximum-tolerated dose MTD when capecitabine
oxaliplatin in a combination regimen with capecitabine and radiotherapy Phase 1
3 To determine the pathologic response rate of cetuximab - oxaliplatin in combination with capecitabine and radiotherapy Phase 2
1 To assess dose-limiting toxicities DLTs of capecitabine - oxaliplatin in a combination regimen with capecitabine and radiotherapy Phase 1
2 To determine the maximum-tolerated dose MTD when capecitabine
oxaliplatin in a combination regimen with capecitabine and radiotherapy Phase 1
3 To determine the pathologic response rate of cetuximab - oxaliplatin in combination with capecitabine and radiotherapy Phase 2
Detailed Description:
Part of the treatment plan for this study is surgical removal of the tumor that is planned to occur 6 to 8 weeks after completion of radiotherapy XRT This study consists of 2 distinct phases Phase 1 and Phase 2
In Phase 1 the objectives are to
1 Assess dose-limiting toxicities DLTs and
2 Determine a maximum-tolerated dose MTD
The Phase 1 endpoints are assessed on an initial cohort of patients after the completion of the chemo-radiotherapy regimen at defined timepoints that precede surgery
Phase 2 is the efficacy assessment portion of this study In Phase 2 the objective is to accrue an expansion cohort Efficacy assessments for phase 2 are to be assessed across all study participants at the time of or after surgery as measured by the pathologic response rate downstaging and survival at 5 years from the start of treatment
In Phase 1 the objectives are to
1 Assess dose-limiting toxicities DLTs and
2 Determine a maximum-tolerated dose MTD
The Phase 1 endpoints are assessed on an initial cohort of patients after the completion of the chemo-radiotherapy regimen at defined timepoints that precede surgery
Phase 2 is the efficacy assessment portion of this study In Phase 2 the objective is to accrue an expansion cohort Efficacy assessments for phase 2 are to be assessed across all study participants at the time of or after surgery as measured by the pathologic response rate downstaging and survival at 5 years from the start of treatment
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?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 95054 | OTHER | Stanford IRB historical | None |
| COR0001 | OTHER | None | None |