ADVANCED AND/OR RECURRENT CERVICAL CANCER MedDRA version: 9.1 Level: LLT Classification code 10008363 Term: Cervix uteri cancer recurrent
Conditions
Interventions
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-
Trad
Sponsors
ISTITUTO NAZIONALE PER LO STUDIO E LA CURA DEI TUMORI - FONDAZIONE "G. PASCALE"
Eligibility
Sex/Gender
All
Inclusion criteria
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
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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 ·Overall survival (OAS) ·Skin toxicity and correlation with cetuximab activity ·EGFR/KRAS expression and correlation with cetuximab activity;Primary end point(s): Event-free survival (EFS) | — |
Countries
Italy
Outcome results
None listed