Ignite Creation Date:
2024-05-05 @ 4:40 PM
Last Modification Date:
2024-10-26 @ 9:23 AM
Study NCT ID:
NCT00292955
Status:
UNKNOWN
Last Update Posted:
2011-05-30
First Post:
2006-02-14
Brief Title:
Cetuximab Cisplatin and Radiotherapy in Women With Locally Advanced Cervical Carcinoma
Sponsor:
University of Virginia
Organization:
University of Virginia
Study Overview
Official Title:
An Exploratory Pharmacogenomic Study of Neoadjuvant Cetuximab Followed by Cisplatin Radiotherapy and Cetuximab in Women With Newly Diagnosed Locally Advanced or Metastatic Cervical Carcinoma
Status:
UNKNOWN
Status Verified Date:
2011-05
Last Known Status:
RECRUITING
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 anti-tumor activity of cetuximab prior to chemoradiotherapy and the safety and tolerability of cetuximab with concurrent chemoradiation will be determined in women with locally advanced or metastatic cervical carcinoma
Detailed Description:
Women with Federation of Gynecology and Obstetrics FIGO Clinical Stage IB2-IVB carcinoma of the cervix
Baseline cervical biopsy blood samples and FDG-PETcomputed tomography CT scan
Cetuximab 400 mgm2 on day 1 followed by cetuximab 250 mgm2 on days 8 and 15
Repeat cervical biopsy and FDG-PETCT scan following cetuximab monotherapy
Radiation and weekly cisplatin 40 mgm2 and cetuximab 250 mg2 for 6 weeks
Cetuximab 250 mgm2 weekly for 12 weeks
Repeat cervical biopsy if tumor present and FDG-PETCT scan after completion of therapy
Follow for tumor recurrence and survival
Baseline cervical biopsy blood samples and FDG-PETcomputed tomography CT scan
Cetuximab 400 mgm2 on day 1 followed by cetuximab 250 mgm2 on days 8 and 15
Repeat cervical biopsy and FDG-PETCT scan following cetuximab monotherapy
Radiation and weekly cisplatin 40 mgm2 and cetuximab 250 mg2 for 6 weeks
Cetuximab 250 mgm2 weekly for 12 weeks
Repeat cervical biopsy if tumor present and FDG-PETCT scan after completion of therapy
Follow for tumor recurrence and survival
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 |
|---|---|---|---|
| HRPO 05-0702 | None | None | None |
| CA225243 | None | None | None |