Erlotinib in Women With Squamous Cell Carcinoma of the Vulvar - Full Text View

Sponsors and Collaborators:	Dana-Farber Cancer Institute Genentech Beth Israel Deaconess Medical Center Brigham and Women's Hospital Women and Infants Hospital of Rhode Island
Information provided by:	Dana-Farber Cancer Institute
ClinicalTrials.gov Identifier:	NCT00476476

Purpose

In this research study we are looking to see how vulvar cancer responds to a short course (4-6 weeks) of erlotinib. 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.

Condition	Intervention	Phase
Squamous Cell Carcinoma	Drug: Erlotinib	Phase II

MedlinePlus related topics: Cancer Vulvar Cancer

Drug Information available for: Erlotinib Erlotinib hydrochloride

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Historical Control, Single Group Assignment, Safety/Efficacy Study
Official Title:	A Phase II Trial of Tarceva (Erlotinib) in Women With Squamous Cell Carcinoma of the Vulvar

Further study details as provided by Dana-Farber Cancer Institute:

Primary Outcome Measures:

To determine the safety and tolerability of oral erlotinib in women with locally advanced primary or recurrent vulvar squamous cell cancer [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
to determine the clinical efficacy of a 4-6 week course of erlotinib in reducing the size of vulvar squamous cell cancer. [ Time Frame: 2 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

To evaluate apoptosis and assess the Ki67, phospho-EGFR, EGFR mutation and EGFR amplification status of the vulvar cancer prior to and after therapy and correlate observed changes with response to therapy [ Time Frame: 2 years ] [ Designated as safety issue: No ]
to evaluate the impact of medical treatment and subsequent surgery for vulvar cancer. [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	41
Study Start Date:	December 2006
Estimated Study Completion Date:	December 2009
Estimated Primary Completion Date:	December 2008 (Final data collection date for primary outcome measure)

Intervention Details:

Orally every day for about 4-6 weeks

Detailed Description:

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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00476476

Contacts

Contact: Neil S. Horowitz, MD

617-732-8834

nhorowitz@partners.org

Locations

United States, Massachusetts
Beth Israel Deaconess Medical Center	Recruiting
Boston, Massachusetts, United States, 02115
Principal Investigator: Christopher Awtrey, MD
Massachusetts General Hospital	Recruiting
Boston, Massachusetts, United States, 02214
Principal Investigator: Linda Duska, MD
Dana-Farber Cancer Institute	Recruiting
Boston, Massachusetts, United States, 02115
Contact: Julie Lee, RN 617-632-4975
Contact: Kim MacNeill 617-632-3743
Principal Investigator: Neil Horowitz, MD
United States, Rhode Island
Women and Infants Hospital of Rhode Island	Recruiting
Providence, Rhode Island, United States
Principal Investigator: Don Dizon, MD

Sponsors and Collaborators

Dana-Farber Cancer Institute

Genentech

Beth Israel Deaconess Medical Center

Brigham and Women's Hospital

Women and Infants Hospital of Rhode Island

Investigators

Principal Investigator:

Neil S. Horowitz, MD

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

More Information

Responsible Party:	Dana-Farber Cancer Institute ( Neil S. Horowitz, MD )
Study ID Numbers:	06-174
Study First Received:	May 18, 2007
Last Updated:	January 6, 2009
ClinicalTrials.gov Identifier:	NCT00476476
Health Authority:	United States: Institutional Review Board

Keywords provided by Dana-Farber Cancer Institute:

Tarceva
erlotinib
squamous cell carcinoma of the vulvar

Study placed in the following topic categories:

Erlotinib
Epidermoid carcinoma
Squamous cell carcinoma
Carcinoma, squamous cell

Neoplasms, Squamous Cell
Carcinoma, Squamous Cell
Neoplasms, Glandular and Epithelial
Carcinoma

Additional relevant MeSH terms:

Neoplasms
Neoplasms by Histologic Type
Molecular Mechanisms of Pharmacological Action

Enzyme Inhibitors
Protein Kinase Inhibitors
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009