Cervix CancerPhase 1NCT00251888
CAmpto-CISplatine Plus Radiotherapy in Advanced Cervix Cancer : Search of Tolerated Maximum Dose of Campto
A Phase 1 study testing campto (irinotecan) and cisplatin (cisplatyl) in people with Cervix Cancer, run by ARCAGY/ GINECO GROUP at 2 sites in France.
Trial summary
Search of maximum tolerated irinotecan dose in association with cisplatin and pelvic radiotherapy in patients with an advanced 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?
- campto (irinotecan) and cisplatin (cisplatyl)
- How many people
- 15 participants
- Where
- 2 sitesFrance
- Study dates
- Nov 2002to Nov 2005
- Phase
- Phase 1
- 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
- Histologically proven primitive epidermoid or andenocarcinoma Cervix
- FIGO stage IIB (obviously parameter attack), III or IVA
- No previous chemotherapy nor radiotherapy
- Patient for whom a radiochemotherapy is envisaged as first intention treatmentof her cervix carcinoma
- PS ECOG < 2
- Life expectancy > 12 weeks
- Written consent given
Who cannot join
- Other malignant cervix tumor histology
- Visceral remotly metastasis
- Other malignant tumor since 5 years, except spino or baso-cellular treaten and cured cancer
- Anormal labs values
- Peripheric neuropathy CTC > 2
- Auditory loss > 2
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- Cardiopathy
- Inflammatory digestive pathology
- Evolutive infection
- Other experimental concommitant treatment
- Lacting or pregnant women
Trial locations and contacts
2 sites in 1 country.
France2 sites
CRLC Val d'Aurelle
Montpellier, 34298
Centre Claudius Régaud
Toulouse, 31052
About this study
Official title: Etude de Recherche de Dose de l'Association Irinotecan (Campto(R)) - Cisplatine (Cisplatyl(R)) Avec la radiothérapie Pelvienne Dans Les Cancers avancés du Col de l'utérus.
Search of maximum tolerated irinotecan dose in association with cisplatin and pelvic radiotherapy in patients with an advanced cervix cancer.
Read the detailed description
To determine the maximum and the recommended tolerated dose of irinotecan with increasing doses associated with weekly cisplatin and combinated with pelvic radiotherapy in patients with an advanced cervix cancer, IIB-IVA FIGO stage.
- Conditions
- Cervix Cancer
- Being tested
- campto (irinotecan), cisplatin (cisplatyl)
- Keywords
- cervix cancer, advanced cervix cancer, radiochemotherapy, pelvic radiotherapy, campto, cisplatin, irinotecan, cisplatyl, maximum dose search
- 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.
campto (irinotecan)Drug
cisplatin (cisplatyl)Drug
What is being measured
The primary outcome is the main question the study is designed to answer.
To determine the maximum tolerated dose of irinotecan associated with cisplatin and combinated with pelvic radiotherapy in patients with an advanced cervix cancer
Secondary outcomes (5)
To evaluate :
the global response rate judged on standard clinical criteria, echography, tomodensiometry, and MRI. The histologic response rate will be appreciated in patients who had a second surgery after pelvic radiochemotherapy
local and general relapse frequency
progression free survival
global survival
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Nov 2005 (estimated)
- Study startNov 2002
- Study completionNov 2005
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 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 15 participants
Sponsor and investigators
- Lead sponsor
- ARCAGY/ GINECO GROUP
- Sponsor type
- University, hospital or other
- Investigators
- Christophe Hennequin, Physician, Principal investigator, Hôpital St Louis, Paris, FranceNadine Dohollou, physician, Principal investigator, Clinique Bordeaux Nord, Bordeaux, France
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00251888
- Sponsor's protocol ID
- CACIS
- Status last verified
- Feb 2011
- First submitted
- 10 Nov 2005
- Last updated
- 25 Jan 2017
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Etude de Recherche de Dose de l'Association Irinotecan (Campto(R)) - Cisplatine (Cisplatyl(R)) Avec la radiothérapie Pelvienne Dans Les Cancers avancés du Col de l'utérus.
- ClinicalTrials.gov ID
- NCT00251888
- Acronym / sponsor ID
- CACIS
- Conditions
- Cervix Cancer
- Keywords
- cervix cancer, advanced cervix cancer, radiochemotherapy, pelvic radiotherapy, campto, cisplatin, irinotecan, cisplatyl
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants
- Lead sponsor
- ARCAGY/ GINECO GROUPUniversity, hospital or other
- Study start
- Nov 2002
- Study completion
- Nov 2005 (actual)
- First posted
- 11 Nov 2005 (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.
Search of maximum tolerated irinotecan dose in association with cisplatin and pelvic radiotherapy in patients with an advanced cervix cancer.
Detailed description
To determine the maximum and the recommended tolerated dose of irinotecan with increasing doses associated with weekly cisplatin and combinated with pelvic radiotherapy in patients with an advanced cervix cancer, IIB-IVA FIGO stage.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- 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 (7 listed)
- Histologically proven primitive epidermoid or andenocarcinoma Cervix
- FIGO stage IIB (obviously parameter attack), III or IVA
- No previous chemotherapy nor radiotherapy
- Patient for whom a radiochemotherapy is envisaged as first intention treatmentof her cervix carcinoma
- PS ECOG < 2
Key exclusion criteria (11 listed)
- Other malignant cervix tumor histology
- Visceral remotly metastasis
- Other malignant tumor since 5 years, except spino or baso-cellular treaten and cured cancer
- Anormal labs values
- Peripheric neuropathy CTC > 2
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 |
|---|---|---|
| campto (irinotecan) | Drug | – |
| cisplatin (cisplatyl) | Drug | – |
Primary outcome
To determine the maximum tolerated dose of irinotecan associated with cisplatin and combinated with pelvic radiotherapy in patients with an advanced cervix cancer
5 secondary outcomes
To evaluate :
the global response rate judged on standard clinical criteria, echography, tomodensiometry, and MRI. The histologic response rate will be appreciated in patients who had a second surgery after pelvic radiochemotherapy
local and general relapse frequency
progression free survival
global survival
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 25 Jan 2017.
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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.
Christophe Hennequin, Physician principal investigator
Hôpital St Louis, Paris, France
Nadine Dohollou, physician principal investigator
Clinique Bordeaux Nord, Bordeaux, France
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing campto (irinotecan) and cisplatin (cisplatyl) in people with Cervix Cancer, run by ARCAGY/ GINECO GROUP at 2 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 7 inclusion and 11 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 25 Jan 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
To determine the maximum tolerated dose of irinotecan associated with cisplatin and combinated with pelvic radiotherapy in patients with an advanced cervix cancer. 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 25 Jan 2017.