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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

Ovarian Cancer

Interventions

capecitabine

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

Useful links and downloads for this trial

Clinicaltrials.gov

Google Search Results

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