Cervix CancerPhase 2ERBUSNCT00518193
Phase II Study , Association of Cisplatine Topotecan and Cetuximab in Patients Whith Late or in Progress Epithelial Cancer of the Cervix
A Phase 2 study testing ERBITUX in people with Cervix Cancer, run by ARCAGY/ GINECO GROUP at 4 sites in France.
Trial summary
The efficacy of chimiotherapy in cervix epithelial cancer is low even with the association cisplatine - topotecan . News thérapeutics are needed in the goal of increase the survival and quality of life in patients with cervix cancer. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Cervix Cancer
- What is being tested?
- ERBITUX
- Type of treatment
- Injection or infusion
- How many people
- 44 participants
- Where
- 4 sitesFrance
- Study dates
- Apr 2007to Sep 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 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- More than 18 years old.
- Epidermoïde carcinoma or adenocarcinoma of the cervix, hystologic proved
- Patientes in a late stage or with progresive desease.
- One mesurable lesion in irradiated zone.
- Patient who have already treated radio-chimiothérapy with platine should have a 6 month free interval.
- Index status of ECOG (" Eastern Cooperative Oncology Group ")less than 2.
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- Good biologicals and hematologicals fonctions:
- Neutrophiles noless than 1,5.109/L.
- Platelets nolss than 100.109/L.
- Total bilirubin no more than 1,5 time the normal superior range.
- Transaminases no mote than 3 x Time NSR
- Creatinine clairance Cockroft) more than 50 mL/min .
- Inform consent signed.
Who cannot join
- Previous cytotoxic traitement exept radio-chaemiotherapy of the pelvis cerebrals metastasis.
- Other cancer in the last 5 years exept treated BCC.
- Dermatologic desease.
- Crohn desease or Hemorragic rectal-Colitis.
- Neuropathy.
- Psychologic disorder.
- Social troubles.
- Pregnant women.
Trial locations and contacts
4 sites in 1 country.
France4 sites
CRLC Val d'Aurelle
Montpellier, 34298
Hôpital HOTEL DIEU
Paris, 75004
Oncologie, Hôtel-Dieu, 1 place du parvis Notre-Dame
Paris, 75004
Centre Claudius Régaud
Toulouse, 31052
About this study
The efficacy of chimiotherapy in cervix epithelial cancer is low even with the association cisplatine - topotecan .
News thérapeutics are needed in the goal of increase the survival and quality of life in patients with cervix cancer.
Cetuximab has shown the potentialisation on the efficacy of cisplatine and irinotecan.
Cisplatine and topotecan have shown an efficacy in cervix cancer. Cetuximab is well tolerate. Many clinical trials shown the faisability of the association of cetuximab and cisplatine in cancer.
Many clinical trials have shown the faisability of association of cetuximab and irinotecan in colorectals metastatiques cancers .
- Conditions
- Cervix Cancer
- Being tested
- ERBITUX
- 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.
ERBITUXDrug
400 mg/m² 2h injection at week 1, then 250 mg/m² in one hour injection the following weeks
What is being measured
The primary outcome is the main question the study is designed to answer.
responses rate regarding the RECIST criteria.
Measured: up to progression
Secondary outcomes (1)
Quality of life, free interval, safety.
Measured: up to progression
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Aug 2007 (estimated)
- Study startApr 2007
- Primary completionJul 2007
- Study completionSep 2008
Why it stopped: high rate of medullar aplasia with infectious troubles.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cervix 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
- 44 participants (actual)
Sponsor and investigators
- Lead sponsor
- ARCAGY/ GINECO GROUP
- Sponsor type
- University, hospital or other
- Investigators
- Pr KURTZ Jean Emmanuel, Principal investigator, STRASBOURG
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00518193
- Sponsor's protocol ID
- ERBUS
- Acronym
- ERBUS
- Status last verified
- Jun 2011
- First submitted
- 14 Aug 2007
- Last updated
- 30 Jun 2011
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 30 Jun 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Study , Association of Cisplatine Topotecan and Cetuximab in Patients Whith Late or in Progress Epithelial Cancer of the Cervix
- ClinicalTrials.gov ID
- NCT00518193
- Acronym / sponsor ID
- ERBUS / ERBUS
- Conditions
- Cervix Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: high rate of medullar aplasia with infectious troubles.
- Enrolment
- 44 participants (actual)
- Lead sponsor
- ARCAGY/ GINECO GROUPUniversity, hospital or other
- Study start
- Apr 2007
- Primary completion
- Jul 2007 (actual)
- Study completion
- Sep 2008 (actual)
- First posted
- 20 Aug 2007 (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 efficacy of chimiotherapy in cervix epithelial cancer is low even with the association cisplatine - topotecan .
News thérapeutics are needed in the goal of increase the survival and quality of life in patients with cervix cancer.
Cetuximab has shown the potentialisation on the efficacy of cisplatine and irinotecan.
Cisplatine and topotecan have shown an efficacy in cervix cancer. Cetuximab is well tolerate. Many clinical trials shown the faisability of the association of cetuximab and cisplatine in cancer.
Many clinical trials have shown the faisability of association of cetuximab and irinotecan in colorectals metastatiques cancers .
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- More than 18 years old.
- Epidermoïde carcinoma or adenocarcinoma of the cervix, hystologic proved
- Patientes in a late stage or with progresive desease.
- One mesurable lesion in irradiated zone.
- Patient who have already treated radio-chimiothérapy with platine should have a 6 month free interval.
Key exclusion criteria (8 listed)
- Previous cytotoxic traitement exept radio-chaemiotherapy of the pelvis cerebrals metastasis.
- Other cancer in the last 5 years exept treated BCC.
- Dermatologic desease.
- Crohn desease or Hemorragic rectal-Colitis.
- Neuropathy.
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 |
|---|---|---|
| ERBITUX400 mg/m² 2h injection at week 1, then 250 mg/m² in one hour injection the following weeks | Drug | – |
Primary outcome
responses rate regarding the RECIST criteria.
Time frame: up to progression
1 secondary outcome
Quality of life, free interval, safety.
Time frame: up to progression
Results and safety
The study was stopped early (reason given: high rate of medullar aplasia with infectious troubles.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jun 2011.
- Related InfoLink provided by the sponsor.
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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.
Pr KURTZ Jean Emmanuel principal investigator
STRASBOURG
4 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 ERBITUX in people with Cervix Cancer, run by ARCAGY/ GINECO GROUP at 4 sites in France.
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 13 inclusion and 8 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: stopped early, as of the sponsor's last update on 30 Jun 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in France. 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 was stopped early (reason given: high rate of medullar aplasia with infectious troubles.). 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?
responses rate regarding the RECIST criteria. (time frame: up to progression). 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 30 Jun 2011; AzTrials last refreshed its copy on 8 Nov 2026.