Clinical trial NCT00403429: 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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Ovarian Cancer
Keywords: oral chemotherapy
platinum resistant
platinum refractory
second line
Lead sponsor: National Cancer Institute, Naples
Sponsor class: OTHER
First posted: 2006-11-23
Enrollment: 36
Sex: FEMALE
Maximum age (years): 75
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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 criteria: 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

Primary outcomes:
measure: objective response rate
timeFrame: 6 months
measure: toxicity
timeFrame: up to 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Avellino
country: Italy
facility: Clinica Malzoni, Reparto di Ginecologia Oncologica
state: AV
city: Acquaviva delle Fonti
country: Italy
facility: Ospedale Regionale Miulli, Divisione Medicina Interna Sezione Oncologica
state: BA
city: Bari
country: Italy
facility: IRCCS Oncologico Bari, Oncologia Medica
state: BA
city: Benevento
country: Italy
facility: Ospedale Fatebenefratelli, U.O. di Oncologia
state: BN
city: Catania
country: Italy
facility: Ospedale Cannizzaro, Divisione di Ostetricia e Ginecologia
state: CT
city: San Giovanni Rotondo
country: Italy
facility: IRCCS Casa Solllievo della Sofferenza
state: FG
city: Mantova
country: Italy
facility: Azienda Ospedaliera Carlo Poma, Divisione di Oncologia ed Ematologia
state: MN
city: Carpi
country: Italy
facility: Ospedale Ramazzini, Day Hospital Oncologico
state: MO
city: Palermo
country: Italy
facility: Policlinico Universitario P. Giaccone
state: PA
city: Palermo
country: Italy
facility: Casa di Cura La Maddalena S.p.A., Dipartimento Oncologico
state: PA
city: Penne
country: Italy
facility: Ospedale S. Massimo, Day Hospital Oncologico
state: PE
city: Aviano
country: Italy
facility: Centro di Riferimento Oncologico, Divisione di Oncolgia Medica C
state: PN
city: Pordenone
country: Italy
facility: Azienda Ospedaliera S. Maria degli Angeli, Servizio di Oncologia
state: PN
city: Vicenza
country: Italy
facility: Ospedale S. Bortolo ULSS 6, U.O. di Oncologia Medica
state: VI
city: Napoli
country: Italy
facility: Istituto Nazionale dei Tumori , Divisione di Oncologia Medica B
city: Napoli
country: Italy
facility: Istituto Nazionale dei Tumori, Divisione di Oncologia Medica C
city: Roma
country: Italy
facility: Ospedale S. Giovanni Calibita Fatebenefratelli
Study officials:
affiliation: National Cancer Institute, Naples
name: Sandro Pignata, M.D., Ph.D
role: PRINCIPAL_INVESTIGATOR
affiliation: National Cancer Institute, Naples
name: Francesco Perrone, M.D., Ph.D
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.