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.
2 other identifiers
interventional
36
1 country
17
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_2 ovarian-cancer
Started Mar 2006
Shorter than P25 for phase_2 ovarian-cancer
17 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2006
CompletedFirst Submitted
Initial submission to the registry
November 22, 2006
CompletedFirst Posted
Study publicly available on registry
November 23, 2006
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2008
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2008
CompletedJanuary 14, 2016
January 1, 2016
1.8 years
November 22, 2006
January 13, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
objective response rate
6 months
toxicity
up to 6 months
Study Arms (1)
Capecitabine
EXPERIMENTALInterventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (17)
Clinica Malzoni, Reparto di Ginecologia Oncologica
Avellino, AV, 83100, Italy
Ospedale Regionale Miulli, Divisione Medicina Interna Sezione Oncologica
Acquaviva delle Fonti, BA, 70021, Italy
IRCCS Oncologico Bari, Oncologia Medica
Bari, BA, 70126, Italy
Ospedale Fatebenefratelli, U.O. di Oncologia
Benevento, BN, 82100, Italy
Ospedale Cannizzaro, Divisione di Ostetricia e Ginecologia
Catania, CT, 95126, Italy
IRCCS Casa Solllievo della Sofferenza
San Giovanni Rotondo, FG, Italy
Azienda Ospedaliera Carlo Poma, Divisione di Oncologia ed Ematologia
Mantova, MN, 46100, Italy
Ospedale Ramazzini, Day Hospital Oncologico
Carpi, MO, 41012, Italy
Policlinico Universitario P. Giaccone
Palermo, PA, 90100, Italy
Casa di Cura La Maddalena S.p.A., Dipartimento Oncologico
Palermo, PA, 90146, Italy
Ospedale S. Massimo, Day Hospital Oncologico
Penne, PE, 65017, Italy
Centro di Riferimento Oncologico, Divisione di Oncolgia Medica C
Aviano, PN, 33081, Italy
Azienda Ospedaliera S. Maria degli Angeli, Servizio di Oncologia
Pordenone, PN, 33170, Italy
Ospedale S. Giovanni Calibita Fatebenefratelli
Roma, Roma, 00186, Italy
Ospedale S. Bortolo ULSS 6, U.O. di Oncologia Medica
Vicenza, VI, 36100, Italy
Istituto Nazionale dei Tumori , Divisione di Oncologia Medica B
Napoli, 80131, Italy
Istituto Nazionale dei Tumori, Divisione di Oncologia Medica C
Napoli, 80131, Italy
Related Publications (1)
Pisano 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: 19266200RESULT
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Sandro Pignata, M.D., Ph.D
National Cancer Institute, Naples
- PRINCIPAL INVESTIGATOR
Francesco Perrone, M.D., Ph.D
National Cancer Institute, Naples
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 22, 2006
First Posted
November 23, 2006
Study Start
March 1, 2006
Primary Completion
January 1, 2008
Study Completion
July 1, 2008
Last Updated
January 14, 2016
Record last verified: 2016-01