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).
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
108
175 mg/m2 IV day 1, every 21 days
AUC 5 IV day 1 every 21 days
400 mg/m2 IV, one week before starting carboplatin and paclitaxel; then 250 mg/m2 IV day 1, weekly
Ospedale Senatore Antonio Perrino
Brindisi, Italy
Ospedale Oncologico A. Businco
Cagliari, Italy
Universita Cattolica del Sacro Cuore
Campobasso, Italy
event free survival
Time frame: after 3 and 6 cycles of treatment (each cycle is 21 days), and every 3 months thereafter up to 18 months
adverse events
according CTCAE criteria
Time frame: after each treatment cycle (each cycle is 21 days) up to 30days
overall survival
Time frame: 18 months
skin toxicity and correlation with cetuximab activity
Time frame: after 3 and 6 cycles of therapy (each cycle is 21 days), and every 3 months thereafter up to 18 months
EGFR/KRAS expression and correlation with cetuximab activity
Time frame: at 18 months
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Istituto Romagnolo per lo Studio e la Cura dei Tumori
Meldola, Italy
Istituto Nazionale Tumori
Milan, Italy
A.O. Unversitaria Policlinico
Modena, Italy
Istituto Nazionale dei Tumori , Oncologia Medica - Dipartimento Uro-Ginecologico
Naples, Italy
A.O. Universitaria Federico II
Naples, Italy
Seconda Università di Napoli
Naples, Italy
Istituto Oncologico Veneto
Padova, Italy
...and 5 more locations