A RANDOMIZED PHASE II STUDY OF CARBOPLATIN AND PACLITAXEL +/- CETUXIMAB, IN ADVANCED AND/OR RECURRENT CERVICAL CANCER - Cetuximab in cervical cancer

INTERVENTION: Trade Name: ERBITUX Pharmaceutical Form: Solution for infusion INN or Proposed INN: Cetuximab Concentration unit: mg/ml milligram(s)/millilitre Concentration type: equal Concentration number: 2‐ Trade Name: PARAPLATIN*IV 1F 150MG LIOF Pharmaceutical Form: Solution for infusion INN or Proposed INN: CARBOPLATINO Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 150‐ Trade Name: TAXOL 100*INF MULT 100MG+COLL Pharmaceutical Form: Solution for infusion INN or Proposed INN: Paclitaxel Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 100‐ CONDITION: ADVANCED AND/OR RECURRENT CERVICAL CANCER ; MedDRA version: 9.1 Level: LLT Classification code 10008363 Term: Cervix uteri cancer recurrent PRIMARY OUTCOME: Main Objective: 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). Primary end point(s): Event‐free survival (EFS) Secondary Objective: ·Toxicity; ·Overall survival (OAS); ·Skin toxicity and correlation with cetuximab activity; ·EGFR/KRAS expression and correlation with cetuximab activity INCLUSION CRITERIA: · Advanced and/or metastatic cervical cancer patients untreated or having failed only one previous chemotherapy (with at least 6 months of progression free interval, with or without concomitant or sequential radiotherapy). · At baseline, presence of at least one measurable target lesion (a lesion that can be accurately measured in at least one dimension i.e. longest diameter ³ 20 mm with conventional CT scan or ³ 10 mm with spiral CT scan according to RECIST Criteria). · Not amenable to surgery and/or radiotherapy. · PS 0‐1 according to ECOG. · Age >18. · Life expectancy of at least 3 months. · Adequate organ functions ‐ Hematopoietic: Leukocytes > 3,000/mm3; Absolute neutrophil count ≥ 1,500/mm3; Platelets count ≥ 100,000/mm3; Hemoglobin ≥ 9 g/dL ‐ Hepatic: AST and ALT ≤ 3 times upper limit of normal (ULN)*; Alkaline phosphatase ≤ 3 times ULN*; Bilirubin ≤ 1.5 times ULN *