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Erlotinib in Women With Squamous Cell Carcinoma of the Vulvar

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ClinicalTrials.gov Identifier: NCT00476476
Recruitment Status : Completed
First Posted : May 22, 2007
Results First Posted : March 19, 2015
Last Update Posted : May 7, 2015
Sponsor:
Collaborators:
Genentech, Inc.
Beth Israel Deaconess Medical Center
Brigham and Women's Hospital
Women and Infants Hospital of Rhode Island
Information provided by (Responsible Party):
Neil S. Horowitz, MD, Dana-Farber Cancer Institute

May 18, 2007
May 22, 2007
March 8, 2015
March 19, 2015
May 7, 2015
December 2006
October 2012   (Final data collection date for primary outcome measure)
Response Rate [ Time Frame: Assessed prior to definitive surgery or chemoradiation therapy (cohort 1 pts) or after 2 cycles of therapy (cohort 2 pts). ]
Response is defined as achieving complete or partial response.Complete response (CR) for both cohorts was defined as resolution of all identified tumor masses on the vulva or disappearance of all target and non-target lesions with no evidence of new lesions documented by two disease assessments at least 4 weeks apart. For cohort 1 pts, a partial response (PR) was defined as a 30% reduction in the product of all diameters of the vulva tumor/tumors compared to baseline measurements. For cohort 2 pts, PR defined according to Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1) was at least a 30% decrease in the sum of the longest diameter (LD) of all target measurable lesions (baseline sum LD reference).
  • To determine the safety and tolerability of oral erlotinib in women with locally advanced primary or recurrent vulvar squamous cell cancer
  • to determine the clinical efficacy of a 4-6 week course of erlotinib in reducing the size of vulvar squamous cell cancer.
Complete list of historical versions of study NCT00476476 on ClinicalTrials.gov Archive Site
Not Provided
  • 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 and subsequent surgery for vulvar cancer.
Not Provided
Not Provided
 
Erlotinib in Women With Squamous Cell Carcinoma of the Vulvar
A Phase II Trial of Tarceva (Erlotinib) in Women With Squamous Cell Carcinoma of the Vulvar
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.

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 3.5% and 15%. If 1 or more patients enrolled in stage one (n=17 patients) achieved PR or better than accrual would proceed to stage two (n=24 patients). There was 0.55 probability of stopping the trial at stage one if the true OR rate was 3.5%. 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 0.0495 with a power of 85% to rule out a poor response rate of less than 3.5%.

Interventional
Phase 2
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Squamous Cell Carcinoma
Drug: Erlotinib
Orally every day for about 4-6 weeks
Other Name: Tarceva
Experimental: Erlotinib
Patients rcvd oral erlotinib 150 mg/day. Cohort 1 pts would have at least 28 days and no more than 42 days of therapy in advance of definitive therapy (surgery or chemoradiation). Cohort 2 pts continued on therapy (28 days per cycle) until disease progression, unacceptable toxicity or withdrawal of consent. Two potential dose reductions were prescribed to 100 and 50 mg/day.
Intervention: Drug: Erlotinib
Horowitz NS, Olawaiye AB, Borger DR, Growdon WB, Krasner CN, Matulonis UA, Liu JF, Lee J, Brard L, Dizon DS. Phase II trial of erlotinib in women with squamous cell carcinoma of the vulva. Gynecol Oncol. 2012 Oct;127(1):141-6. doi: 10.1016/j.ygyno.2012.06.028. Epub 2012 Jun 26.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
41
Same as current
October 2012
October 2012   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Histologically confirmed measurable squamous cell carcinoma of the vulvar with an assessable lesion on the vulva or measurable metastatic disease. Tumors may be primary or recurrent. Patients must have plans for surgery or definitive treatment with chemotherapy +/-radiation unless they have measurable metastatic disease.
  • 18 years of age or older
  • No concurrent chemotherapy or radiotherapy
  • NO previous chemotherapy or radiotherapy within the preceding 1 month
  • ECOG performance status of 0-1

Exclusion Criteria:

  • Known hypersensitivity reaction to erlotinib
  • Other coexisting malignancies diagnosed within the last 5 years, with the exception of basal cell carcinoma
  • Treatment with a non-FDA approved or investigational drug within 30 days
  • Persistent toxicities (grade 2 or above) from previous treatment, expect alopecia or lymphedema
  • Serum creatinine level greater than CTC grade 2
  • Pregnancy or breast feeding
  • Severe or uncontrolled systemic disease
  • Significant clinical disorder or laboratory finding that makes it potentially unsafe for the subject to participate
Sexes Eligible for Study: Female
18 Years and older   (Adult, Older Adult)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00476476
06-174
Yes
Not Provided
Not Provided
Neil S. Horowitz, MD, Dana-Farber Cancer Institute
Dana-Farber Cancer Institute
  • Genentech, Inc.
  • Beth Israel Deaconess Medical Center
  • Brigham and Women's Hospital
  • Women and Infants Hospital of Rhode Island
Principal Investigator: Neil S. Horowitz, MD Dana-Farber Cancer Institute/Brigham and Women's Hospital
Dana-Farber Cancer Institute
March 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP