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Ovarian CancerPhase 2NCT00403429

MITO-6: Capecitabine in Platinum Resistant Ovarian Cancer

A Phase 2 study testing capecitabine in people with Ovarian Cancer, run by National Cancer Institute, Naples at 17 sites in Italy.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Ages Up to 75 years, women only
Conditions the study is for
Ovarian Cancer
What is being tested?
capecitabine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
36 participants
Where
17 sitesItaly
Study dates
Mar 2006to Jul 2008
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages Up to 75 years
  • Women only
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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
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  • 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

Trial locations and contacts

17 sites in 1 country.

17 sites in 1 country

Italy17 sites

  • Ospedale Regionale Miulli, Divisione Medicina Interna Sezione Oncologica

    Acquaviva delle Fonti, BA, 70021

  • Clinica Malzoni, Reparto di Ginecologia Oncologica

    Avellino, AV, 83100

  • Centro di Riferimento Oncologico, Divisione di Oncolgia Medica C

    Aviano, PN, 33081

  • IRCCS Oncologico Bari, Oncologia Medica

    Bari, BA, 70126

  • Ospedale Fatebenefratelli, U.O. di Oncologia

    Benevento, BN, 82100

  • Ospedale Ramazzini, Day Hospital Oncologico

    Carpi, MO, 41012

  • Ospedale Cannizzaro, Divisione di Ostetricia e Ginecologia

    Catania, CT, 95126

  • Azienda Ospedaliera Carlo Poma, Divisione di Oncologia ed Ematologia

    Mantua, MN, 46100

  • Istituto Nazionale dei Tumori , Divisione di Oncologia Medica B

    Naples, 80131

  • Istituto Nazionale dei Tumori, Divisione di Oncologia Medica C

    Naples, 80131

  • Policlinico Universitario P. Giaccone

    Palermo, PA, 90100

  • Casa di Cura La Maddalena S.p.A., Dipartimento Oncologico

    Palermo, PA, 90146

  • Ospedale S. Massimo, Day Hospital Oncologico

    Penne, PE, 65017

  • Azienda Ospedaliera S. Maria degli Angeli, Servizio di Oncologia

    Pordenone, PN, 33170

  • Ospedale S. Giovanni Calibita Fatebenefratelli

    Roma, Roma, 00186

  • IRCCS Casa Solllievo della Sofferenza

    San Giovanni Rotondo, FG

  • Ospedale S. Bortolo ULSS 6, U.O. di Oncologia Medica

    Vicenza, VI, 36100

Other trials in Italy

About this study

Official title: 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.

Read the 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.

Conditions
Ovarian Cancer
Being tested
capecitabine
Keywords
oral chemotherapy, platinum resistant, platinum refractory, second line
Medical subject headings
Ovarian Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT00403429
Study groupRoleWhat they receive
CapecitabineExperimentalNot described
Receives: Drug: capecitabine

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. objective response rate

    Measured: 6 months

  2. toxicity

    Measured: up to 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted23 Nov 2006 (estimated)
  2. Study startMar 2006
  3. Primary completionJan 2008
  4. Study completionJul 2008

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
36 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00403429
Sponsor's protocol ID
MITO-6
Other IDs
EudraCT number 2006-001724-40
Status last verified
Jan 2016
First submitted
22 Nov 2006
Last updated
14 Jan 2016
Results posted
No

Publications

  • 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.

    PubMed 19266200

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing capecitabine in people with Ovarian Cancer, run by National Cancer Institute, Naples at 17 sites in Italy.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 14 Jan 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 17 sites in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

objective response rate (time frame: 6 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00403429, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jan 2016.

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