MITO-6: Capecitabine in Platinum Resistant Ovarian Cancer

Phase 2

Completed

• Conditions: Ovarian Cancer
• Interventions: Drug: capecitabine

• Registration Number: NCT00403429
• Lead Sponsor: National Cancer Institute, Naples

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.

Study Timeline

• Study Start: 2006-03
• Study First Submitted: 2006-11-22
• Study First Submitted QC: 2006-11-22
• Study First Posted: 2006-11-23
• Primary Completion: 2008-01
• Study Completion: 2008-07
• Status Verified: 2016-01
• Last Update Submitted: 2016-01-13
• Last Update Posted: 2016-01-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 36

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Capecitabine	capecitabine	-

Primary Outcome Measures

Name	Time	Method
objective response rate	6 months
toxicity	up to 6 months

Trial Locations

Locations (17)

Clinica Malzoni, Reparto di Ginecologia Oncologica; 🇮🇹 Avellino, AV, Italy

Ospedale Ramazzini, Day Hospital Oncologico; 🇮🇹 Carpi, MO, 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

Ospedale Regionale Miulli, Divisione Medicina Interna Sezione Oncologica; 🇮🇹 Acquaviva delle Fonti, BA, Italy

IRCCS Casa Solllievo della Sofferenza; 🇮🇹 San Giovanni Rotondo, FG, Italy

Ospedale S. Massimo, Day Hospital Oncologico; 🇮🇹 Penne, PE, Italy

Azienda Ospedaliera Carlo Poma, Divisione di Oncologia ed Ematologia; 🇮🇹 Mantova, MN, Italy

Policlinico Universitario P. Giaccone; 🇮🇹 Palermo, PA, Italy

Casa di Cura La Maddalena S.p.A., Dipartimento Oncologico; 🇮🇹 Palermo, PA, Italy

Centro di Riferimento Oncologico, Divisione di Oncolgia Medica C; 🇮🇹 Aviano, PN, Italy

Ospedale S. Bortolo ULSS 6, U.O. di Oncologia Medica; 🇮🇹 Vicenza, VI, Italy

Azienda Ospedaliera S. Maria degli Angeli, Servizio di Oncologia; 🇮🇹 Pordenone, PN, 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