Cancer of the Cervix Clinical Trial
Official title:
An Exploratory Pharmacogenomic Study of Neoadjuvant Cetuximab Followed by Cisplatin, Radiotherapy, and Cetuximab in Women With Newly Diagnosed Locally Advanced or Metastatic Cervical Carcinoma
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
;
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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