Clinical trial · Interventional
MITO-6: Capecitabine in Platinum Resistant Ovarian Cancer
Phase II Study With Capecitabine as Monotherapy in the Treatment of Platinum Resistant or Refractory Ovarian Cancer.
NCT00403429CI-TRIAL-00020537completedPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Ovarian Cancer | Malignant Ovarian Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| capecitabine | Drug | Capecitabine | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Capecitabine
- interventionNames
- Drug: capecitabine
Primary outcomes (2)
- measure
- objective response rate
- timeFrame
- 6 months
- measure
- toxicity
- timeFrame
- up to 6 months
Eligibility
Eligibility (as posted)
- Sex
- Female
- Maximum age
- 75 Years
Show eligibility criteria text
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
References
Publications (1)
- RESULTPisano C, Morabito A, Sorio R, Breda E, Lauria R, Gebbia V, Scaltriti L, Scalone S, Zagonel V, Greggi S, Beneduce G, Losito S, Gallo C, Di Maio M, Forestieri V, Pignata S. A phase II study of capecitabine in the treatment of ovarian cancer resistant or refractory to platinum therapy: a multicentre Italian trial in ovarian cancer (MITO-6) trial. Cancer Chemother Pharmacol. 2009 Oct;64(5):1021-7. doi: 10.1007/s00280-009-0958-0. Epub 2009 Mar 6. PMID 19266200