Erlotinib in Women With Squamous Cell Carcinoma of the Vulvar

NCT00476476 | Completed Phase 2 Results DMC

• 1 other identifier: 06-174
• Study Type: interventional
• Target: 41
• Locations: 1 country
• Sites: 4

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.

Conditions

Squamous Cell Carcinoma

Keywords

Tarceva; erlotinib; squamous cell carcinoma of the vulvar

Outcome Measures

Primary Outcomes (1)

• Response Rate

  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).

  Assessed prior to definitive surgery or chemoradiation therapy (cohort 1 pts) or after 2 cycles of therapy (cohort 2 pts).

Study Arms (1)

Erlotinib

EXPERIMENTAL

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.

Drug: Erlotinib

Interventions

Erlotinib DRUG

Orally every day for about 4-6 weeks

Also known as: Tarceva

Erlotinib

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Dana-Farber Cancer Institute: lead
• Genentech, Inc.: collaborator
• Beth Israel Deaconess Medical Center: collaborator
• Brigham and Women's Hospital: collaborator
• Women and Infants Hospital of Rhode Island: collaborator

Study Sites (4)

Beth Israel Deaconess Medical Center

Boston, Massachusetts, 02115, United States

Location

Massachusetts General Hospital

Boston, Massachusetts, 02214, United States

Location

Dana-Farber Cancer Institute

Boston, Massachusetts, 02215, United States

Location

Women and Infants Hospital of Rhode Island

Providence, Rhode Island, 02905, United States

Location

Related Publications (1)

• 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.

  PMID: 22750258 RESULT

MeSH Terms

Conditions

Carcinoma, Squamous Cell

Interventions

Erlotinib Hydrochloride

Condition Hierarchy (Ancestors)

Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Squamous Cell

Intervention Hierarchy (Ancestors)

Quinazolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Results Point of Contact

• Title: Neil Horowitz MD
• Organization: Dana-Farber Cancer Institute

NHOROWITZ@mgh.harvard.edu

617.732.8843

Study Officials

• Neil S. Horowitz, MD

  Dana-Farber Cancer Institute/Brigham and Women's Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: May 18, 2007
• First Posted: May 22, 2007
• Study Start: December 1, 2006
• Primary Completion: October 1, 2012
• Study Completion: October 1, 2012
• Last Updated: May 7, 2015
• Results First Posted: March 19, 2015

Record last verified: 2015-03

Locations

US (4)