NCT00997009

Study of Adding Cetuximab to Chemotherapy for the Treatment of Advanced and/or Recurrent Cervical Cancer

Randomized Phase II Study of Carboplatin and Paclitaxel +/- Cetuximab, in Advanced and/or Recurrent Cervical Cancer

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 108 (estimated)
• Sponsor: National Cancer Institute, Naples · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This study aims to assess the activity of a combination of cetuximab (weekly) with carboplatin + paclitaxel (every three weeks) comparing it to chemotherapy alone in terms of event-free survival (EFS).

Detailed description

The poor long-term results in the standard treatment of chemotherapy for cervical cancer make research into new, more beneficial treatment strategies necessary. Cetuximab is a new type of drug that blocks the epidermal growth factor receptor (anti-EFGR), and has shown significant activity in other cancers (colon, head and neck) where expression of EGFR is high. Cervical cancer cells express EGFR in a very high proportion of cases, especially in recurrent or resistant disease. This study evaluates the activity of the addition of cetuximab to full doses of carboplatin and paclitaxel.

Conditions

• Cervical Cancer

Interventions

Type	Name	Description
DRUG	paclitaxel	175 mg/m2 IV day 1, every 21 days
DRUG	carboplatin	AUC 5 IV day 1 every 21 days
DRUG	cetuximab	400 mg/m2 IV, one week before starting carboplatin and paclitaxel; then 250 mg/m2 IV day 1, weekly

Timeline

• Start date: 2009-10-01
• Primary completion: 2024-12-01
• Completion: 2024-12-01
• First posted: 2009-10-16
• Last updated: 2023-11-14

Locations

15 sites across 1 country: Italy