The anti-tumor activity of cetuximab prior to chemoradiotherapy and the safety and tolerability of cetuximab with concurrent chemoradiation will be determined in women with locally advanced or metastatic cervical carcinoma.
* Women with Federation of Gynecology and Obstetrics (FIGO) Clinical Stage IB2-IVB carcinoma of the cervix * Baseline cervical biopsy, blood samples, and FDG-PET/computed tomography (CT) scan * Cetuximab 400 mg/m2 on day 1 followed by cetuximab 250 mg/m2 on days 8 and 15 * Repeat cervical biopsy and FDG-PET/CT scan following cetuximab monotherapy * Radiation and weekly cisplatin 40 mg/m2 and cetuximab 250 mg/2 for 6 weeks * Cetuximab 250 mg/m2 weekly for 12 weeks * Repeat cervical biopsy (if tumor present) and FDG-PET/CT scan after completion of therapy * Follow for tumor recurrence and survival
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
30
monotherapy (day 1), then weekly thereafter along with radiation. dose is at 200mg/m2.
Washinton University School of Medicine
St Louis, Missouri, United States
SUSPENDEDUniversity of Virginia Cancer Center
Charlottesville, Virginia, United States
RECRUITINGTo identify genes that may be identified as predictive of response to cetuximab
Time frame: completion
To sequence the epidermal growth factor receptor (EGFR) to describe mutations in the receptor that may predict tumor response to cetuximab
Time frame: completion
To evaluate the validity of fluorodeoxyglucose (FDG) uptake, as determined by positron emission tomography (PET) imaging, as a surrogate marker for response to cetuximab
Time frame: completion
To determine the safety and tolerability of cetuximab with concurrent chemoradiation in women with locally advanced cervical carcinoma
Time frame: weekly
To determine the progression-free and overall survival in women with locally advanced or metastatic cervical carcinoma treated with concurrent chemoradiation and cetuximab
Time frame: every three months
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