MITO-6: Capecitabine in Platinum Resistant Ovarian Cancer - Full Text View

Sponsored by:	National Cancer Institute, Naples
Information provided by:	National Cancer Institute, Naples
ClinicalTrials.gov Identifier:	NCT00403429

Purpose

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.

Condition	Intervention	Phase
Ovarian Cancer	Drug: capecitabine	Phase II

MedlinePlus related topics: Cancer Ovarian Cancer

Drug Information available for: Capecitabine

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
Official Title:	Phase II Study With Capecitabine as Monotherapy in the Treatment of Platinum Resistant or Refractory Ovarian Cancer.

Further study details as provided by National Cancer Institute, Naples:

Primary Outcome Measures:

objective response rate
toxicity

Estimated Enrollment:	32
Study Start Date:	March 2006

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

Ages Eligible for Study:	up to 75 Years
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00403429

Locations

Italy
Istituto Nazionale dei Tumori , Divisione di Oncologia Medica B
Napoli, Italy, 80131
Istituto Nazionale dei Tumori, Divisione di Oncologia Medica C
Napoli, Italy, 80131
Ospedale S. Giovanni Calibita Fatebenefratelli
Roma, Italy, 00186
Italy, AV
Clinica Malzoni, Reparto di Ginecologia Oncologica
Avellino, AV, Italy, 83100
Italy, BA
IRCCS Oncologico Bari, Oncologia Medica
Bari, BA, Italy, 70126
Ospedale Regionale Miulli, Divisione Medicina Interna Sezione Oncologica
Acquaviva delle Fonti, BA, Italy, 70021
Italy, BN
Ospedale Fatebenefratelli, U.O. di Oncologia
Benevento, BN, Italy, 82100
Italy, CT
Ospedale Cannizzaro, Divisione di Ostetricia e Ginecologia
Catania, CT, Italy, 95126
Italy, FG
IRCCS Casa Solllievo della Sofferenza
San Giovanni Rotondo, FG, Italy
Italy, MN
Azienda Ospedaliera Carlo Poma, Divisione di Oncologia ed Ematologia
Mantova, MN, Italy, 46100
Italy, MO
Ospedale Ramazzini, Day Hospital Oncologico
Carpi, MO, Italy, 41012
Italy, PA
Policlinico Universitario P. Giaccone
Palermo, PA, Italy, 90100
Casa di Cura La Maddalena S.p.A., Dipartimento Oncologico
Palermo, PA, Italy, 90146
Italy, PE
Ospedale S. Massimo, Day Hospital Oncologico
Penne, PE, Italy, 65017
Italy, PN
Centro di Riferimento Oncologico, Divisione di Oncolgia Medica C
Aviano, PN, Italy, 33081
Azienda Ospedaliera S. Maria degli Angeli, Servizio di Oncologia
Pordenone, PN, Italy, 33170
Italy, VI
Ospedale S. Bortolo ULSS 6, U.O. di Oncologia Medica
Vicenza, VI, Italy, 36100

Sponsors and Collaborators

National Cancer Institute, Naples

Investigators

Principal Investigator:	Sandro Pignata, M.D., Ph.D	National Cancer Institute, Naples
Principal Investigator:	Francesco Perrone, M.D., Ph.D	National Cancer Institute, Naples

More Information

Study ID Numbers:	MITO-6, EudraCT number 2006-001724-40
Study First Received:	November 22, 2006
Last Updated:	October 1, 2007
ClinicalTrials.gov Identifier:	NCT00403429
Health Authority:	Italy: Ethics Committee

Keywords provided by National Cancer Institute, Naples:

oral chemotherapy
platinum resistant
platinum refractory
second line

Study placed in the following topic categories:

Genital Diseases, Female
Ovarian cancer
Capecitabine
Ovarian Neoplasms
Gonadal Disorders
Genital Neoplasms, Female

Endocrine System Diseases
Urogenital Neoplasms
Endocrinopathy
Ovarian Diseases
Endocrine Gland Neoplasms

Additional relevant MeSH terms:

Antimetabolites
Neoplasms
Antimetabolites, Antineoplastic
Neoplasms by Site
Molecular Mechanisms of Pharmacological Action

Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Adnexal Diseases

ClinicalTrials.gov processed this record on January 14, 2009