Overview

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