Cetuximab, Cisplatin, and Radiotherapy in Women With Locally Advanced Cervical Carcinoma

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

Status Recruiting

Clinical Trial Summary

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.

Clinical Trial Description

• 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 Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cancer of the Cervix
• Uterine Cervical Neoplasms

• NCT number: NCT00292955
• Study type: Interventional
• Source: University of Virginia
• Contact: Meredith Gross, M.S.
• Phone: 434-924-0436
• Email: mpg8b@virginia.edu
• Status: Recruiting
• Phase: Phase 2
• Start date: February 2006