Erlotinib in Women With Squamous Cell Carcinoma of the Vulvar

• Status: Completed
• Trial end date: 2012-10-01
• Target enrollment: 0
• Participant gender: Female

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Dana-Farber Cancer Institute
• Collaborators: Beth Israel Deaconess Medical Center; Brigham and Women's Hospital; Genentech, Inc.; Women and Infants Hospital of Rhode Island
• Treatments: Erlotinib Hydrochloride

Criteria

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