MITO-6: Capecitabine in Platinum Resistant Ovarian Cancer

• Status: Completed
• Trial end date: 2008-07-01
• Target enrollment: 0
• Participant gender: Female

Summary

The purpose of this study is to evaluate the activity and the toxicity of capecitabine as monotherapy in the treatment of platinum resistant or refractory ovarian cancer.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: National Cancer Institute, Naples
• Treatments: Capecitabine

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 (³ 20 mm with conventional techniques or ³ 10 mm with spiral CT scan)

• Life expectancy of at least 3 months

• Written informed consent

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 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 (Creatinine ³ 1.25 times the upper normal limit) or liver function (SGOT or SGPT ³ 1.25 times the upper normal limit)

• Present or suspected haemorrhagic syndromes

• Uncooperative and/or unreliable patients

• Patients' inability to access the centre