MITO-6: Capecitabine in Platinum Resistant Ovarian Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00403429
Recruitment Status : Completed
First Posted : November 23, 2006
Last Update Posted : January 14, 2016
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Ovarian Cancer Drug: capecitabine Phase 2

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 Type : Interventional  (Clinical Trial)
Actual Enrollment : 36 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase II Study With Capecitabine as Monotherapy in the Treatment of Platinum Resistant or Refractory Ovarian Cancer.
Study Start Date : March 2006
Primary Completion Date : January 2008
Study Completion Date : July 2008

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Ovarian Cancer
U.S. FDA Resources

Arm Intervention/treatment
Experimental: Capecitabine Drug: capecitabine

Primary Outcome Measures :
  1. objective response rate [ Time Frame: 6 months ]
  2. toxicity [ Time Frame: up to 6 months ]

Information from the National Library of Medicine

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Ages Eligible for Study:   up to 75 Years   (Child, Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00403429

Clinica Malzoni, Reparto di Ginecologia Oncologica
Avellino, AV, Italy, 83100
Ospedale Regionale Miulli, Divisione Medicina Interna Sezione Oncologica
Acquaviva delle Fonti, BA, Italy, 70021
IRCCS Oncologico Bari, Oncologia Medica
Bari, BA, Italy, 70126
Ospedale Fatebenefratelli, U.O. di Oncologia
Benevento, BN, Italy, 82100
Ospedale Cannizzaro, Divisione di Ostetricia e Ginecologia
Catania, CT, Italy, 95126
IRCCS Casa Solllievo della Sofferenza
San Giovanni Rotondo, FG, Italy
Azienda Ospedaliera Carlo Poma, Divisione di Oncologia ed Ematologia
Mantova, MN, Italy, 46100
Ospedale Ramazzini, Day Hospital Oncologico
Carpi, MO, Italy, 41012
Policlinico Universitario P. Giaccone
Palermo, PA, Italy, 90100
Casa di Cura La Maddalena S.p.A., Dipartimento Oncologico
Palermo, PA, Italy, 90146
Ospedale S. Massimo, Day Hospital Oncologico
Penne, PE, Italy, 65017
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
Ospedale S. Bortolo ULSS 6, U.O. di Oncologia Medica
Vicenza, VI, Italy, 36100
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
Sponsors and Collaborators
National Cancer Institute, Naples
Principal Investigator: Sandro Pignata, M.D., Ph.D National Cancer Institute, Naples
Principal Investigator: Francesco Perrone, M.D., Ph.D National Cancer Institute, Naples

Publications of Results:
Responsible Party: National Cancer Institute, Naples Identifier: NCT00403429     History of Changes
Other Study ID Numbers: MITO-6
EudraCT number 2006-001724-40
First Posted: November 23, 2006    Key Record Dates
Last Update Posted: January 14, 2016
Last Verified: January 2016

Keywords provided by National Cancer Institute, Naples:
oral chemotherapy
platinum resistant
platinum refractory
second line

Additional relevant MeSH terms:
Ovarian Neoplasms
Endocrine Gland Neoplasms
Neoplasms by Site
Ovarian Diseases
Adnexal Diseases
Genital Diseases, Female
Genital Neoplasms, Female
Urogenital Neoplasms
Endocrine System Diseases
Gonadal Disorders
Antimetabolites, Antineoplastic
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents