Erlotinib in Women With Squamous Cell Carcinoma of the Vulvar

Part of paid clinical trials in Boston, Massachusetts.

Sponsor
Dana-Farber Cancer Institute
Study ID
NCT00476476
Phase
PHASE2
Status
Completed

Conditions

Eligibility Criteria

Sex
FEMALE
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Erlotinib — DRUG
    Orally every day for about 4-6 weeks

Study Details

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.

Key Dates

First listed
May 22, 2007
Start date
Dec 31, 2006
Status verified
Mar 2015
Primary completion
Oct 31, 2012
Completion
Oct 31, 2012

Study Design

Enrollment
41 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Erlotinib
    Patients rcvd oral erlotinib 150 mg/day. Cohort 1 pts would have at least 28 days and no more than 42 days of therapy in advance of definitive therapy (surgery or chemoradiation). Cohort 2 pts continued on therapy (28 days per cycle) until disease progression, unacceptable toxicity or withdrawal of consent. Two potential dose reductions were prescribed to 100 and 50 mg/day.

Primary Outcome Measure

Response Rate [ Time Frame: Assessed prior to definitive surgery or chemoradiation therapy (cohort 1 pts) or after 2 cycles of therapy (cohort 2 pts). ]

Locations (4)

FacilityCityStateZIPSite coordinators
Beth Israel Deaconess Medical CenterBostonMassachusetts02115-
Dana-Farber Cancer InstituteBostonMassachusetts02215-
Massachusetts General HospitalBostonMassachusetts02214-
Women and Infants Hospital of Rhode IslandProvidenceRhode Island02905-

Find similar trials in Boston, MA

By condition
Skin cancer
By specialty
OncologySkin cancerDermatology
By research site
Beth Israel Deaconess Medical Center· Boston, MADana-Farber Cancer Institute· Boston, MAMassachusetts General Hospital· Boston, MAWomen and Infants Hospital of Rhode Island· Providence, RI

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