NCT00292955

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

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: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 30 (estimated)
• Sponsor: University of Virginia · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed 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

Conditions

• Cancer of the Cervix

Interventions

Type	Name	Description
DRUG	Cetuximab	monotherapy (day 1), then weekly thereafter along with radiation. dose is at 200mg/m2.

Timeline

• Start date: 2006-02-01
• Primary completion: 2012-02-01
• First posted: 2006-02-16
• Last updated: 2011-05-30

Locations

2 sites across 1 country: United States