Status:
COMPLETED
MITO-6: Capecitabine in Platinum Resistant Ovarian Cancer
Lead Sponsor:
National Cancer Institute, Naples
Conditions:
Ovarian Cancer
Eligibility:
FEMALE
Up to 75 years
Phase:
PHASE2
Brief 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.
Detailed 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 i...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
March 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2008
Estimated Enrollment :
36 Patients enrolled
Trial Details
Trial ID
NCT00403429
Start Date
March 1 2006
End Date
July 1 2008
Last Update
January 14 2016
Active Locations (17)
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1
Clinica Malzoni, Reparto di Ginecologia Oncologica
Avellino, AV, Italy, 83100
2
Ospedale Regionale Miulli, Divisione Medicina Interna Sezione Oncologica
Acquaviva delle Fonti, BA, Italy, 70021
3
IRCCS Oncologico Bari, Oncologia Medica
Bari, BA, Italy, 70126
4
Ospedale Fatebenefratelli, U.O. di Oncologia
Benevento, BN, Italy, 82100