MITO-6: Capecitabine in Platinum Resistant Ovarian Cancer

Ovarian Cancer Clinical Trial

Official title:

Phase II Study With Capecitabine as Monotherapy in the Treatment of Platinum Resistant or Refractory Ovarian Cancer.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00403429
• Other study ID #: MITO-6
• Secondary ID: EudraCT number 2
• Status: Completed
• Phase: Phase 2
• First received: November 22, 2006
• Last updated: January 13, 2016
• Start date: March 2006
• Est. completion date: July 2008

Study information

• Verified date: January 2016
• Source: National Cancer Institute, Naples
• Contact: n/a
• Is FDA regulated: No
• Health authority: Italy: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 36
• Est. completion date: July 2008
• Est. primary completion date: January 2008
• Accepts healthy volunteers: No
• Gender: Female
• Age group: N/A to 75 Years

Eligibility

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

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Ovarian Cancer
• Ovarian Neoplasms

Intervention

Drug:
• capecitabine

Locations

Country	Name	City	State
Italy	Ospedale Regionale Miulli, Divisione Medicina Interna Sezione Oncologica	Acquaviva delle Fonti	BA
Italy	Clinica Malzoni, Reparto di Ginecologia Oncologica	Avellino	AV
Italy	Centro di Riferimento Oncologico, Divisione di Oncolgia Medica C	Aviano	PN
Italy	IRCCS Oncologico Bari, Oncologia Medica	Bari	BA
Italy	Ospedale Fatebenefratelli, U.O. di Oncologia	Benevento	BN
Italy	Ospedale Ramazzini, Day Hospital Oncologico	Carpi	MO
Italy	Ospedale Cannizzaro, Divisione di Ostetricia e Ginecologia	Catania	CT
Italy	Azienda Ospedaliera Carlo Poma, Divisione di Oncologia ed Ematologia	Mantova	MN
Italy	Istituto Nazionale dei Tumori , Divisione di Oncologia Medica B	Napoli
Italy	Istituto Nazionale dei Tumori, Divisione di Oncologia Medica C	Napoli
Italy	Casa di Cura La Maddalena S.p.A., Dipartimento Oncologico	Palermo	PA
Italy	Policlinico Universitario P. Giaccone	Palermo	PA
Italy	Ospedale S. Massimo, Day Hospital Oncologico	Penne	PE
Italy	Azienda Ospedaliera S. Maria degli Angeli, Servizio di Oncologia	Pordenone	PN
Italy	Ospedale S. Giovanni Calibita Fatebenefratelli	Roma
Italy	IRCCS Casa Solllievo della Sofferenza	San Giovanni Rotondo	FG
Italy	Ospedale S. Bortolo ULSS 6, U.O. di Oncologia Medica	Vicenza	VI

Sponsors (1)

Lead Sponsor	Collaborator
National Cancer Institute, Naples

Country where clinical trial is conducted

Italy, 

References & 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 re — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	objective response rate		6 months	No
Primary	toxicity		up to 6 months	Yes