A Trial of Erlotinib + Radiotherapy for Cutaneous Squamous Cell Carcinoma

Part of paid clinical trials in Birmingham, Alabama.

Sponsor
University of Alabama at Birmingham
Study ID
NCT00369512
Phase
PHASE2
Status
Completed

Conditions

  • Cancer

Eligibility Criteria

Sex
ALL
Age
19 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Erlotinib — DRUG
    Erlotinib therapy for 2 weeks (150 mg po qd)(for those who are enrolled before surgery is done), surgery/biopsy up to 8 weeks recovery, radiation/Erlotinib therapy for 6 weeks (150mg po qd).

Study Details

This is a phase II study designed to study the effectiveness of combined radiotherapy and erlotinib in the postoperative setting for patients with cutaneous SCC that are at high risk for recurrence. Participants enrolled in the study will be evaluated by a head and neck surgeon, and a radiation oncologist. Whenever possible, a preoperative biopsy will be performed after participant enrollment in the study for histological confirmation and for molecular correlates. Participants enrolled prior to surgical resection will begin erlotinib at 150 mg by mouth (PO) every day (QD) (14 tablets) to be taken 14 days prior to surgical resection. Following planned surgical resection, the participant will begin Erlotinib therapy and radiotherapy at the same time and within 4-8 weeks of the surgical resection.

Key Dates

First listed
Aug 29, 2006
Start date
Aug 31, 2006
Status verified
May 2017
Primary completion
Jan 31, 2012
Completion
Sep 30, 2012

Study Design

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

Arms

  • Experimental: Erlotinib
    Erlotinib therapy for 2 weeks (150 mg po qd)(for those who are enrolled before surgery is done), surgery/biopsy up to 8 weeks recovery, radiation/Erlotinib therapy for 6 weeks (150mg po qd).

Primary Outcome Measure

Toxicities Associated With Combined Radiotherapy and Erlotinib Treatments. [ Time Frame: 2 years ]

Locations (1)

FacilityCityStateZIPSite coordinators
University of Alabama at Birmingham Medical CenterBirminghamAlabama35233-

Find similar trials in Birmingham, AL

By research site
University of Alabama at Birmingham Medical Center· Birmingham, AL

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