Phase 2 N=41 Treatment

Erlotinib in Women With Squamous Cell Carcinoma of the Vulvar

Squamous Cell Carcinoma

Bottom Line

View on ClinicalTrials.gov: NCT00476476 ↗

Enrolled (actual)

Serious AEs

46.3%

Results posted

Mar 2015

Primary outcome: Primary: Response Rate — .35; .22 proportion of participants

Study Design & Population

Study type: Interventional
Phase: Phase 2
Interventions: Erlotinib (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: Female
Sponsor: Dana-Farber Cancer Institute
Primary completion: Oct 2012

Outcome Measures

Outcome	Result	p-value
PRIMARY Response Rate	.35; .22	—

Summary

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.

Eligibility 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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00476476). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.