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

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2006-001724-40-IT

Enrollment

Registered

2006-06-23

Start date

2005-10-18

Completion date

Unknown

Last updated

2025-01-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Interventions

Pharmaceutical Form: Coated tablet INN or Proposed INN: Capecitabine Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 500- Pharmaceutical Form: Coated tablet INN or

Eligibility

Sex/Gender

All

Inclusion criteria

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

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

Design outcomes

Primary

Measure	Time frame
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	—

Countries

Italy

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026