MITO-6: Capecitabine in Platinum Resistant Ovarian Cancer

National Cancer Institute, Naples

Status and phase

Completed

Phase 2

Conditions

Ovarian Cancer

Treatments

Drug: capecitabine

Study type

Interventional

Funder types

Other

Identifiers

NCT00403429

EudraCT number 2006-001724-40

MITO-6

Details and patient eligibility

About

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.

Full description

Ovarian cancer is the second most frequent and the most deadly gynaecologic cancer. Standard combination chemotherapy with a platinum derivative (cisplatin or carboplatin) and a taxane are effective in causing remission in 60 - 80 % of cases, yet recurrences are frequent and 5-year survival is only 20%. Current therapies for second line treatment of recurrence in patients who have platinum refractory (who experienced progression of the disease during first line platinum based therapy) or platinum resistant (who experienced a recurrence of the disease within 6 months of completing platinum based therapy)ovarian cancer are limited. Capecitabine, an oral chemotherapy already used in colon and breast cancers, has shown some promise in early clinical trials for treating recurrent ovarian cancer.

Patients entered into this trial will receive oral capecitabine 1250 mg/m2 on days 1-14 every 21 days for up to 6 cycles, depending on response.

Enrollment

36 patients

Sex

Female

Ages

Under 75 years old

Volunteers

No Healthy Volunteers

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