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

Phase 2
18 Years
Not Enrolling
Squamous Cell Carcinoma

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Trial Information

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

- Participants will take erlotinib everyday for about four to six weeks (28-42 days).
Erlotinib is a pill that is taken orally. Participants will receive a drug diary to
record each dose of erlotinib they take. While participants are taking erlotinib, they
will be contacted by telephone once a week.

- Participants will receive additional treatment that is standard for their stage of
cancer when they stop study treatment. If they are undergoing surgery to remove the
cancer the surgery will be performed on the day of their last dose of erlotinib. A
piece of tumor tissue will be saved for research-related tests. If they are receiving
chemotherapy and/or radiation therapy to treat the cancer, a biopsy will be done before
they begin chemotherapy or radiation. A piece of the biopsy sample will be used for
research-related tests.

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

- 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

Type of Study:


Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

To determine the safety and tolerability of oral erlotinib in women with locally advanced primary or recurrent vulvar squamous cell cancer

Outcome Time Frame:

2 years

Safety Issue:


Principal Investigator

Neil S. Horowitz, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

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


United States: Institutional Review Board

Study ID:




Start Date:

December 2006

Completion Date:

October 2012

Related Keywords:

  • Squamous Cell Carcinoma
  • Tarceva
  • erlotinib
  • squamous cell carcinoma of the vulvar
  • Carcinoma
  • Carcinoma, Squamous Cell



Beth Israel Deaconess Medical Center Boston, Massachusetts  02215
Dana-Farber Cancer Institute Boston, Massachusetts  02115
Women and Infants Hospital of Rhode Island Providence, Rhode Island  02905
Massachusetts General Hospital Boston, Massachusetts  02114-2617