Cervical CancerPhase 2MITO CERV 2NCT00997009
Study of Adding Cetuximab to Chemotherapy for the Treatment of Advanced and/or Recurrent Cervical Cancer
A Phase 2 study testing paclitaxel, carboplatin and cetuximab in people with Cervical Cancer, run by National Cancer Institute, Naples at 15 sites in Italy.
Trial summary
This study aims to assess the activity of a combination of cetuximab (weekly) with carboplatin + paclitaxel (every three weeks) comparing it to chemotherapy alone in terms of event-free survival (EFS). Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Cervical Cancer
- What is being tested?
- paclitaxel, carboplatin and cetuximab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 108 participants
- Where
- 15 sitesItaly
- Study dates
- Oct 2009to Dec 2024
- 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 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Advanced and/or metastatic cervical cancer patients untreated or having failed only one previous chemotherapy (with at least 6 months of progression free interval, with or without concomitant or sequential radiotherapy).
- At baseline, presence of at least one measurable target lesion (a lesion that can be accurately measured in at least one dimension i.e. longest diameter at least 20 mm with conventional CT scan or at least 10 mm with spiral CT scan according to RECIST Criteria).
- Not amenable to surgery and/or radiotherapy.
- PS 0-1 according to ECOG.
- Age >18.
- Life expectancy of at least 3 months.
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- Adequate organ functions
- Hematopoietic: Leukocytes > 3,000/mm3; Absolute neutrophil count > or = 1,500/mm3; Platelets count > or = 100,000/mm3; Hemoglobin > or = 9 g/dL
- Hepatic: AST and ALT < or = 3 times upper limit of normal (ULN)*; Alkaline phosphatase < or = 3 times ULN*; Bilirubin < or = 1.5 times ULN
- : < or = 5 times ULN if liver metastases are present
- Renal: Creatinine clearance > or = 45 mL/min
- No other invasive malignancy within the past 5 years except non-melanoma skin cancer.
- All radiology studies must be performed within 28 days prior to randomization.
- Absence of any psychological, familial, sociological or geographical conditions potentially hampering compliance with the study protocol and follow-up schedule.
- Written informed consent.
Who cannot join
- Pregnant (potentially fertile patients must use contraceptive measures to avoid pregnancy during and for at least 3 months after study participation and must have a negative serum pregnancy test at baseline).
- Patients should not be breast-feeding during treatment and for 2 months following the end of treatment.
- More than one previous chemotherapy line.
- Active infection requiring antibiotics.
- Symptomatic peripheral neuropathy >grade 2 according to the CTCAE.
- Congestive heart failure or angina pectoris even if it is medically controlled. Previous history of myocardial infarction within 1 year from study entry, uncontrolled high risk hypertension or arrhythmia.
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- Known hypersensitivity to the study drugs or to drugs with similar chemical structures.
- Concurrent treatment with other experimental drugs.
- Participation in another clinical trial with any investigational drug within 30 days prior to study screening.
Trial locations and contacts
15 sites in 1 country.
15 sites in 1 country
Italy15 sites
Ospedale Senatore Antonio Perrino
Brindisi
Ospedale Oncologico A. Businco
Cagliari
Universita Cattolica del Sacro Cuore
Campobasso
Istituto Romagnolo per lo Studio e la Cura dei Tumori
Meldola
Istituto Nazionale Tumori
Milan
A.O. Unversitaria Policlinico
Modena
Istituto Nazionale dei Tumori , Oncologia Medica - Dipartimento Uro-Ginecologico
Naples, 80131
A.O. Universitaria Federico II
Naples
Seconda Università di Napoli
Naples
Istituto Oncologico Veneto
Padova
Ospedale Silvestrini
Perugia
Istituto Regina Elena
Roma
Universita Cattolica del Sacro Cuore
Roma
Ospedale S. Chiara
Trento
A.O. di Udine S. Maria della Misericordia
Udine
About this study
Official title: Randomized Phase II Study of Carboplatin and Paclitaxel +/- Cetuximab, in Advanced and/or Recurrent Cervical Cancer
This study aims to assess the activity of a combination of cetuximab (weekly) with carboplatin + paclitaxel (every three weeks) comparing it to chemotherapy alone in terms of event-free survival (EFS).
Read the detailed description
The poor long-term results in the standard treatment of chemotherapy for cervical cancer make research into new, more beneficial treatment strategies necessary. Cetuximab is a new type of drug that blocks the epidermal growth factor receptor (anti-EFGR), and has shown significant activity in other cancers (colon, head and neck) where expression of EGFR is high. Cervical cancer cells express EGFR in a very high proportion of cases, especially in recurrent or resistant disease. This study evaluates the activity of the addition of cetuximab to full doses of carboplatin and paclitaxel.
- Conditions
- Cervical Cancer
- Being tested
- paclitaxel, carboplatin, cetuximab
- Keywords
- EGFR, chemotherapy
- Medical subject headings
- Uterine Cervical Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
paclitaxelDrug
175 mg/m2 IV day 1, every 21 days
carboplatinDrug
AUC 5 IV day 1 every 21 days
cetuximabDrug
400 mg/m2 IV, one week before starting carboplatin and paclitaxel; then 250 mg/m2 IV day 1, weekly
| Study group | Role | What they receive |
|---|---|---|
| Arm A | Experimental | chemotherapy plus cetuximab Receives: Drug: paclitaxel; Drug: carboplatin; Drug: cetuximab |
| Arm B | Active comparator | chemotherapy Receives: Drug: paclitaxel; Drug: carboplatin |
What is being measured
The primary outcome is the main question the study is designed to answer.
event free survival
Measured: after 3 and 6 cycles of treatment (each cycle is 21 days), and every 3 months thereafter up to 18 months
Secondary outcomes (4)
adverse events
according CTCAE criteria
Measured: after each treatment cycle (each cycle is 21 days) up to 30days
overall survival
Measured: 18 months
skin toxicity and correlation with cetuximab activity
Measured: after 3 and 6 cycles of therapy (each cycle is 21 days), and every 3 months thereafter up to 18 months
EGFR/KRAS expression and correlation with cetuximab activity
Measured: at 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Oct 2009 (estimated)
- Study startOct 2009
- Primary completionDec 2024 (estimated)
- Study completionDec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cervical 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 108 participants (estimated)
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, NaplesAlessandro Morabito, M.D.,, Principal investigator, National Cancer Institute, NaplesCiro Gallo, M.D., Ph.D., Principal investigator, University of Campania Luigi Vanvitelli
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00997009
- Sponsor's protocol ID
- MITO CERV 2
- Other IDs
- 2009-010099-74, 2009
- Acronym
- MITO CERV 2
- Status last verified
- Mar 2023
- First submitted
- 15 Oct 2009
- Last updated
- 14 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Phase II Study of Carboplatin and Paclitaxel +/- Cetuximab, in Advanced and/or Recurrent Cervical Cancer
- ClinicalTrials.gov ID
- NCT00997009
- Acronym / sponsor ID
- MITO CERV 2 / MITO CERV 2
- Conditions
- Cervical Cancer
- Keywords
- EGFR, chemotherapy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 108 participants (estimated)
- Lead sponsor
- National Cancer Institute, NaplesUniversity, hospital or other
- Study start
- Oct 2009
- Primary completion
- Dec 2024 (estimated)
- Study completion
- Dec 2024 (estimated)
- First posted
- 16 Oct 2009 (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.
This study aims to assess the activity of a combination of cetuximab (weekly) with carboplatin + paclitaxel (every three weeks) comparing it to chemotherapy alone in terms of event-free survival (EFS).
Detailed description
The poor long-term results in the standard treatment of chemotherapy for cervical cancer make research into new, more beneficial treatment strategies necessary. Cetuximab is a new type of drug that blocks the epidermal growth factor receptor (anti-EFGR), and has shown significant activity in other cancers (colon, head and neck) where expression of EGFR is high. Cervical cancer cells express EGFR in a very high proportion of cases, especially in recurrent or resistant disease. This study evaluates the activity of the addition of cetuximab to full doses of carboplatin and paclitaxel.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm A | Experimental | Drug: paclitaxel, Drug: carboplatin, Drug: cetuximabchemotherapy plus cetuximab |
| Arm B | Active comparator | Drug: paclitaxel, Drug: carboplatinchemotherapy |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- Advanced and/or metastatic cervical cancer patients untreated or having failed only one previous chemotherapy (with at least 6 months of progression free interval, with or without concomitant or sequential radiotherapy).
- At baseline, presence of at least one measurable target lesion (a lesion that can be accurately measured in at least one dimension i.e. longest diameter at least 20 mm with conventional CT scan or at least 10 mm with spiral CT scan according to RECIST Criteria).
- Not amenable to surgery and/or radiotherapy.
- PS 0-1 according to ECOG.
- Age >18.
Key exclusion criteria (9 listed)
- Pregnant (potentially fertile patients must use contraceptive measures to avoid pregnancy during and for at least 3 months after study participation and must have a negative serum pregnancy test at baseline).
- Patients should not be breast-feeding during treatment and for 2 months following the end of treatment.
- More than one previous chemotherapy line.
- Active infection requiring antibiotics.
- Symptomatic peripheral neuropathy >grade 2 according to the CTCAE.
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 |
|---|---|---|
| paclitaxel175 mg/m2 IV day 1, every 21 days | Drug | Arm A, Arm B |
| carboplatinAUC 5 IV day 1 every 21 days | Drug | Arm A, Arm B |
| cetuximab400 mg/m2 IV, one week before starting carboplatin and paclitaxel; then 250 mg/m2 IV day 1, weekly | Drug | Arm A |
Primary outcome
event free survival
Time frame: after 3 and 6 cycles of treatment (each cycle is 21 days), and every 3 months thereafter up to 18 months
4 secondary outcomes
adverse events
Time frame: after each treatment cycle (each cycle is 21 days) up to 30days
overall survival
Time frame: 18 months
skin toxicity and correlation with cetuximab activity
Time frame: after 3 and 6 cycles of therapy (each cycle is 21 days), and every 3 months thereafter up to 18 months
EGFR/KRAS expression and correlation with cetuximab activity
Time frame: at 18 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Nov 2023.
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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
Alessandro Morabito, M.D., principal investigator
National Cancer Institute, Naples
15 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 paclitaxel, carboplatin and cetuximab in people with Cervical Cancer, run by National Cancer Institute, Naples at 15 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 15 inclusion and 9 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: status not confirmed, as of the sponsor's last update on 14 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 15 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?
Results are not available in the source record.
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?
event free survival (time frame: after 3 and 6 cycles of treatment (each cycle is 21 days), and every 3 months thereafter up to 18 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 Nov 2023.