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.
Interventional
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
To determine the safety and tolerability of oral erlotinib in women with locally advanced primary or recurrent vulvar squamous cell cancer
2 years
Yes
Neil S. Horowitz, MD
Principal Investigator
Dana-Farber Cancer Institute/Brigham and Women's Hospital
United States: Institutional Review Board
06-174
NCT00476476
December 2006
October 2012
Name | Location |
---|---|
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 |