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

• Conditions: ADVANCED AND/OR RECURRENT CERVICAL CANCER; MedDRA version: 9.1Level: LLTClassification code 10008363Term: Cervix uteri cancer recurrent

• Registration Number: EUCTR2009-010099-74-IT
• Lead Sponsor: ISTITUTO NAZIONALE PER LO STUDIO E LA CURA DEI TUMORI - FONDAZIONE G. PASCALE

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2009-04-17
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: Female
• Target Recruitment: Not specified

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
*: ≤ 5 times ULN if liver metastases are present
-Renal: Creatinine clearance ≥ 45 mL/min
·No other invasive malignancy within the past 5 years except non-melanoma skin cancer
·All radiology studies must be performed within 28 days prior to randomization.
·Absence of any psychological, familial, sociological or geographical conditions potentially hampering compliance with the study protocol and follow-up schedule.
·Written informed consent.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

·Pregnant (potentially fertile patients must use contraceptive measures to avoid pregnancy during and for at least 3 months after study participation and must have a negative serum pregnancy test at baseline).
·Patients should not be breast-feeding during treatment and for 2 months following the end of treatment.
·More than one previous chemotherapy line.
·Active infection requiring antibiotics.
·Symptomatic peripheral neuropathy >grade 2 according to the CTCAE.
·Congestive heart failure or angina pectoris even if it is medically controlled. Previous history of myocardial infarction within 1 year from study entry, uncontrolled high risk hypertension or arrhythmia.
·Known hypersensitivity to the study drugs or to drugs with similar chemical structures.
·Concurrent treatment with other experimental drugs.
·Participation in another clinical trial with any investigational drug within 30 days prior to study screening.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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).;Secondary Objective: ·Toxicity<br>·Overall survival (OAS)<br>·Skin toxicity and correlation with cetuximab activity<br>·EGFR/KRAS expression and correlation with cetuximab activity;Primary end point(s): Event-free survival (EFS)