Phase II study with capecitabine as monotherapy in the treatment of platinum resistant or refractory ovarian cancer - MITO-6

Conditions: Cytologic or histologic diagnosis of relapsed ovarian cancer, refractory or resistant to platinum salts.
MedDRA version: 6.1Level: PTClassification code 10061328

Registration Number: EUCTR2006-001724-40-IT

Lead Sponsor: ISTITUTO NAZIONALE PER LO STUDIO E LA CURA DEI TUMORI - FONDAZIONE G. PASCALE

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Authorised-recruitment may be ongoing or finished

Sex: Female

Target Recruitment: 32

Inclusion Criteria

Cytologic or histologic diagnosis of relapsed ovarian cancer Refractory or resistant to platinum salts disease Age 75 years At least one measurable lesion 20 mm with conventional techniques or 10 mm with spiral CT scan Life expectancy of at least 3 months 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) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

Previous or concomitant malignant neoplasia within 5 years prior to basal evaluation excluding adequately treated basocellular or spinocellular skin carcinoma or in situ carcinoma of the uterine cervix . Performance Status ECOG 3 Previous chemotherapy treatment with capecitabine More than 3 lines of chemotherapy Heart disease heart failure, heart attack during the 6 months prior to the trial, atrioventricular block of any degree, serious arrhythmia Leukocytes 4000/mm3, platelets 100000/mm3 Modifications of renal function Creatininaemia 1.25 times the upper normal limit or liver function SGOT or SGPT 1.25 times the upper normal limit Present or suspected haemorrhagic syndromes Uncooperative and/or unreliable patients Patients inability to access the centre

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To evaluate the activity and the toxicity of capecitabine as monotherapy in the treatment of platinum resistant or refractory ovarian cancer;Secondary Objective: ND;Primary end point(s): Response Rate Complete response partial response

Secondary Outcome Measures