MITO-6: Capecitabine in Platinum Resistant Ovarian Cancer

January 13, 2016 updated by: National Cancer Institute, Naples

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Enrollment (Actual)

36

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

No older than 75 years (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Capecitabine
Drug: capecitabine

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
objective response rate
Time Frame: 6 months
6 months
toxicity
Time Frame: up to 6 months
up to 6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National Cancer Institute, Naples

Investigators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2006

Primary Completion (Actual)

January 1, 2008

Study Completion (Actual)

July 1, 2008

Study Registration Dates

First Submitted

November 22, 2006

First Submitted That Met QC Criteria

November 22, 2006

First Posted (Estimate)

November 23, 2006

Study Record Updates

Last Update Posted (Estimate)

January 14, 2016

Last Update Submitted That Met QC Criteria

January 13, 2016

Last Verified

January 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MITO-6
  • EudraCT number 2006-001724-40

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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