Ignite Creation Date:
2024-05-05 @ 5:30 PM
Last Modification Date:
2024-10-26 @ 9:33 AM
Study NCT ID:
NCT00476476
Status:
COMPLETED
Last Update Posted:
2015-05-07
First Post:
2007-05-18
Brief Title:
Erlotinib in Women With Squamous Cell Carcinoma of the Vulvar
Sponsor:
Dana-Farber Cancer Institute
Organization:
Dana-Farber Cancer Institute
Study Overview
Official Title:
A Phase II Trial of Tarceva Erlotinib in Women With Squamous Cell Carcinoma of the Vulvar
Status:
COMPLETED
Status Verified Date:
2015-03
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:
In this research study we are looking to see how vulvar cancer responds to erlotinib therapy Two distinct patient populations are targeted women with locally advanced measurable squamous cell carcinoma of the vulva primary or recurrent who are candidates for definitive treatment with surgery or chemoradiation Cohort 1 and women with radiographically measurable distant metastatic cancer either at time of presentation or with recurrence Cohort 2 Another goal of this study is to learn more about the proteins and genes present in vulvar cancer and how they may affect response to erlotinib Erlotinib treats cancer by preventing cancer cells from growing and multiplying It does this by blocking certain proteins that are on the surface of some types of cancer cells Laboratory tests show that vulvar cancer cells have high levels of these proteins
Detailed Description:
OBJECTIVES
Primary
To determine the clinical efficacy of erlotinib in reducing the size of vulvar squamous cell cancer and or metastatic lesions
Secondary
To determine the safety and tolerability of oral erlotinib
To evaluate apoptosis and assess the Ki67 phospho-EGFR EGFR mutation and EGFR amplification status of the vulvar cancer prior to and after therapy and correlate observed changes with response to therapy
To evaluate the impact of medical treatment on the subsequent surgery for vulvar cancer when surgery is chosen as the definitive therapy
STATISTICAL DESIGN
This study used a two-stage design to evaluate efficacy of erlotinib based on response determined prior to definitive surgery or chemoradiation cohort 1 or after every 2 cycles of erlotinib cohort 2 The null and alternative response rates defined as achieving partial response PR or better were 35 and 15 If 1 or more patients enrolled in stage one n17 patients achieved PR or better than accrual would proceed to stage two n24 patients There was 055 probability of stopping the trial at stage one if the true OR rate was 35 If 3 or fewer responses were observed by the end of stage two erlotinib would be deemed ineffective The significance level of the study design was 00495 with a power of 85 to rule out a poor response rate of less than 35
Primary
To determine the clinical efficacy of erlotinib in reducing the size of vulvar squamous cell cancer and or metastatic lesions
Secondary
To determine the safety and tolerability of oral erlotinib
To evaluate apoptosis and assess the Ki67 phospho-EGFR EGFR mutation and EGFR amplification status of the vulvar cancer prior to and after therapy and correlate observed changes with response to therapy
To evaluate the impact of medical treatment on the subsequent surgery for vulvar cancer when surgery is chosen as the definitive therapy
STATISTICAL DESIGN
This study used a two-stage design to evaluate efficacy of erlotinib based on response determined prior to definitive surgery or chemoradiation cohort 1 or after every 2 cycles of erlotinib cohort 2 The null and alternative response rates defined as achieving partial response PR or better were 35 and 15 If 1 or more patients enrolled in stage one n17 patients achieved PR or better than accrual would proceed to stage two n24 patients There was 055 probability of stopping the trial at stage one if the true OR rate was 35 If 3 or fewer responses were observed by the end of stage two erlotinib would be deemed ineffective The significance level of the study design was 00495 with a power of 85 to rule out a poor response rate of less than 35
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