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CompletedNCT00401674MITO-5Updated Jan 14, 2016

MITO-5: Weekly Carboplatin and Paclitaxel as First Line Chemotherapy for Elderly Patients With Ovarian Cancer

A Phase 2 interventional study of carboplatin and paclitaxel in Ovarian Cancer, sponsored by National Cancer Institute, Naples. Completed at 10 sites in Italy. Open to female participants aged 70 Years and older. Per ClinicalTrials.gov, last updated 2016-01-14.

Sponsored by National Cancer Institute, Naples · Phase 2, Interventional, and Treatment

Phase
Phase 2
Study type
Interventional
Enrollment
26
Allocation
Not applicable
Ages
70 Years and older
Sex
Female
01

Study summary

The purpose of this study is to evaluate the toxicity and activity of weekly administration of carboplatin and paclitaxel as first-line chemotherapy for elderly patients with ovarian cancer stage IC-IV.

Read the detailed description

This is a phase II multicenter study. The experimental treatment is carboplatin (AUC 2) and paclitaxel 60 mg/m2, on days 1, 8 and 15 every 28 days.

02

Conditions studied

  • Ovarian Cancer

Keywords

  • ovarian cancer
  • elderly
  • weekly chemotherapy
  • first-line
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In context

Ovarian Neoplasms

2,695 studies on the registry are indexed under Ovarian Neoplasms; 727 are open to participants now.

This study's enrollment of 26 is below the median of 60 across 2,030 interventional studies indexed under Ovarian Neoplasms.

Browse Ovarian Neoplasms studies →

Lead sponsor

National Cancer Institute, Naples is the lead sponsor of 112 studies on the registry; 39 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
70 Years and older
Sexes eligible
Female
Accepts healthy volunteers
No

Inclusion criteria

  • Age 70 years or greater
  • Cytologic / histologic diagnosis ovarian cancer
  • Stage of disease at diagnosis IC -IV
  • Performance status (ECOG) \< 3
  • Indication for chemotherapy treatment
  • Written informed consent

Exclusion criteria

Exclusion Criteria:

  • Previous or concomitant malignant neoplasia (not including basocellular or spinocellular skin carcinoma or in-situ carcinoma of the uterine cervix, provided they are being adequately treated)
  • Cerebral metastases
  • Neutrophils \< 1000/mm3, platelets \< 100000/mm3, hemoglobin \< 8g/dl
  • Creatinine > o = 1.25 times the upper normal limit
  • GOT or GPT > o = 1.25 times the upper normal limit, except in case of liver metastases)
  • Patient's inability to comply with followup
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Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
26 participants (actual)

Study arms

  • Experimental
    SINGLE ARM

    Drug: carboplatin · Drug: paclitaxel

Interventions

  • Drugcarboplatin
  • Drugpaclitaxel
06

What researchers measure

Primary outcomes

  1. Objective response rate

    Time frame: 6 month

  2. Toxicity

    assessed weekly

    Time frame: up to 6 months

Secondary outcomes

  1. possible predictive factors of the geriatric ADL and IADL scales

    Time frame: 6 months

07

Study locations

10 sites
  • Ospedale Fatebenefratelli, U.O. di Oncologia
    Benevento, BN 82100, Italy
  • Università Cattolica del Sacro Cuore, Dipartimento di Oncologia
    Campobasso, CB 86100, Italy
  • Ospedale Cannizzaro
    Cannizzaro, CT, Italy
  • Azienda Ospedaliera Carlo Poma, Divisione di Oncologia ed Ematologia
    Mantova, MN 46100, Italy
  • Ospedale S. Massimo
    Penne, PE, Italy
  • Ospedale Civile Umberto I, Day Hospital Oncoematologico
    Nocera Inferiore, SA 84014, Italy
  • Ospedale S. Bortolo ULSS 6, U.O. di Oncologia Medica
    Vicenza, VI 36100, Italy
  • Istituto Nazionale dei Tumori , Divisione di Oncologia Medica B
    Napoli, 80131, Italy
  • Istituto Nazionale dei Tumori, Divisione di Oncologia Medica C
    Napoli, 80131, Italy
  • Ospedale S. Giovanni Calibita Fatebenefratelli
    Roma, 00186, Italy
08

References and documents

Publications

  • Pignata S, Breda E, Scambia G, Pisano C, Zagonel V, Lorusso D, Greggi S, De Vivo R, Ferrandina G, Gallo C, Perrone F. A phase II study of weekly carboplatin and paclitaxel as first-line treatment of elderly patients with advanced ovarian cancer. A Multicentre Italian Trial in Ovarian cancer (MITO-5) study. Crit Rev Oncol Hematol. 2008 Jun;66(3):229-36. doi: 10.1016/j.critrevonc.2007.12.005. Epub 2008 Feb 1. PubMed 18243011 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 14, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT00401674
Lead sponsor
National Cancer Institute, Naples
Responsible party
Sponsor
First posted
Nov 20, 2006
Start date
Jun 2003
Primary completion
Jun 2008
Completion
Jun 2008
Last update
Jan 14, 2016

Study contacts

Sandro Pignata, M.D., Ph.D
principal investigator · National Cancer Institute, Naples
Francesco Perrone, M.D., Ph.D
principal investigator · National Cancer Institute, Naples
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Jan 2016. You cannot join it, but the record below documents what was studied.

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