Spots Global Cancer Trial Database for MITO-6: Capecitabine in Platinum Resistant Ovarian Cancer
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Trial Identification
Brief Title: MITO-6: Capecitabine in Platinum Resistant Ovarian Cancer
Official Title: Phase II Study With Capecitabine as Monotherapy in the Treatment of Platinum Resistant or Refractory Ovarian Cancer.
Study ID: NCT00403429
Conditions
Interventions
Study Description
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 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.
Eligibility
Minimum Age:
Eligible Ages: CHILD, ADULT, OLDER_ADULT
Sex: FEMALE
Healthy Volunteers: No
Locations
Clinica Malzoni, Reparto di Ginecologia Oncologica, Avellino, AV, Italy
Ospedale Regionale Miulli, Divisione Medicina Interna Sezione Oncologica, Acquaviva delle Fonti, BA, Italy
IRCCS Oncologico Bari, Oncologia Medica, Bari, BA, Italy
Ospedale Fatebenefratelli, U.O. di Oncologia, Benevento, BN, Italy
Ospedale Cannizzaro, Divisione di Ostetricia e Ginecologia, Catania, CT, Italy
IRCCS Casa Solllievo della Sofferenza, San Giovanni Rotondo, FG, Italy
Azienda Ospedaliera Carlo Poma, Divisione di Oncologia ed Ematologia, Mantova, MN, Italy
Ospedale Ramazzini, Day Hospital Oncologico, Carpi, MO, Italy
Policlinico Universitario P. Giaccone, Palermo, PA, Italy
Casa di Cura La Maddalena S.p.A., Dipartimento Oncologico, Palermo, PA, Italy
Ospedale S. Massimo, Day Hospital Oncologico, Penne, PE, Italy
Centro di Riferimento Oncologico, Divisione di Oncolgia Medica C, Aviano, PN, Italy
Azienda Ospedaliera S. Maria degli Angeli, Servizio di Oncologia, Pordenone, PN, Italy
Ospedale S. Bortolo ULSS 6, U.O. di Oncologia Medica, Vicenza, VI, Italy
Istituto Nazionale dei Tumori , Divisione di Oncologia Medica B, Napoli, , Italy
Istituto Nazionale dei Tumori, Divisione di Oncologia Medica C, Napoli, , Italy
Ospedale S. Giovanni Calibita Fatebenefratelli, Roma, , Italy
Contact Details
Name: Sandro Pignata, M.D., Ph.D
Affiliation: National Cancer Institute, Naples
Role: PRINCIPAL_INVESTIGATOR
Name: Francesco Perrone, M.D., Ph.D
Affiliation: National Cancer Institute, Naples
Role: PRINCIPAL_INVESTIGATOR
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