Ovarian CancerPhase 2MITO-5NCT00401674
MITO-5: Weekly Carboplatin and Paclitaxel as First Line Chemotherapy for Elderly Patients With Ovarian Cancer
A Phase 2 study testing carboplatin and paclitaxel in people with Ovarian Cancer, run by National Cancer Institute, Naples at 10 sites in Italy.
Trial 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 more about this study
- Who is it for?
- Ages 70 years and older, women only
- Conditions the study is for
- Ovarian Cancer
- What is being tested?
- carboplatin and paclitaxel
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 26 participants
- Where
- 10 sitesItaly
- Study dates
- Jun 2003to Jun 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 70 years and older
- Women only
- No healthy volunteers
- Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
10 sites in 1 country.
10 sites in 1 country
Italy10 sites
Ospedale Fatebenefratelli, U.O. di Oncologia
Benevento, BN, 82100
Università Cattolica del Sacro Cuore, Dipartimento di Oncologia
Campobasso, CB, 86100
Ospedale Cannizzaro
Cannizzaro, CT
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
Ospedale Civile Umberto I, Day Hospital Oncoematologico
Nocera Inferiore, SA, 84014
Ospedale S. Massimo
Penne, PE
Ospedale S. Giovanni Calibita Fatebenefratelli
Roma, Roma, 00186
Ospedale S. Bortolo ULSS 6, U.O. di Oncologia Medica
Vicenza, VI, 36100
About this study
Official title: Phase II Multicenter Study of the Combination of Weekly Carboplatin and Paclitaxel as First-line Chemotherapy for Elderly Patients With Ovarian Cancer.
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.
- Conditions
- Ovarian Cancer
- Being tested
- carboplatin, paclitaxel
- Keywords
- ovarian cancer, elderly, weekly chemotherapy, first-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.
carboplatinDrug
paclitaxelDrug
| Study group | Role | What they receive |
|---|---|---|
| SINGLE ARM | Experimental | Not described Receives: Drug: carboplatin; Drug: paclitaxel |
What is being measured
The primary outcome is the main question the study is designed to answer.
Objective response rate
Measured: 6 month
Toxicity
assessed weekly
Measured: up to 6 months
Secondary outcomes (1)
possible predictive factors of the geriatric ADL and IADL scales
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Nov 2006 (estimated)
- Study startJun 2003
- Primary completionJun 2008
- Study completionJun 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Ovarian CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- 26 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Cancer Institute, Naples
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Sandro Pignata, M.D., Ph.D, Principal investigator, National Cancer Institute, NaplesFrancesco Perrone, M.D., Ph.D, Principal investigator, National Cancer Institute, Naples
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00401674
- Sponsor's protocol ID
- MITO-5
- Acronym
- MITO-5
- Status last verified
- Jan 2016
- First submitted
- 17 Nov 2006
- Last updated
- 14 Jan 2016
- Results posted
- No
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
Study at a glance
From the registry record, last updated by the sponsor on 14 Jan 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Multicenter Study of the Combination of Weekly Carboplatin and Paclitaxel as First-line Chemotherapy for Elderly Patients With Ovarian Cancer.
- ClinicalTrials.gov ID
- NCT00401674
- Acronym / sponsor ID
- MITO-5 / MITO-5
- Conditions
- Ovarian Cancer
- Keywords
- ovarian cancer, elderly, weekly chemotherapy, first-line
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 26 participants (actual)
- Lead sponsor
- National Cancer Institute, NaplesUniversity, hospital or other
- Study start
- Jun 2003
- Primary completion
- Jun 2008 (actual)
- Study completion
- Jun 2008 (actual)
- First posted
- 20 Nov 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| SINGLE ARM | Experimental | Drug: carboplatin, Drug: paclitaxel |
Who may qualify
- Ages
- 70 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (6 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| carboplatin | Drug | SINGLE ARM |
| paclitaxel | Drug | SINGLE ARM |
Primary outcome
Objective response rate
Time frame: 6 month
Toxicity
Time frame: up to 6 months
assessed weekly
1 secondary outcome
possible predictive factors of the geriatric ADL and IADL scales
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jan 2016.
- Results publication: PubMed 18243011Pignata 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sandro Pignata, M.D., Ph.D principal investigator
National Cancer Institute, Naples
Francesco Perrone, M.D., Ph.D principal investigator
National Cancer Institute, Naples
10 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing carboplatin and paclitaxel in people with Ovarian Cancer, run by National Cancer Institute, Naples at 10 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 6 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 10 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 month). 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 NCT00401674, 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.