A Phase II Trial of Tarceva (Erlotinib) in Women With Squamous Cell Carcinoma of the Vulvar

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