Genital Neoplasms, MalePhase 2NCT00210041
Phase 2 Study of Association Gemcitabine-Cisplatin to Treat Penis Epidermoid Carcinoma
A Phase 2 study testing Gemcitabine and Cisplatin in people with Genital Neoplasms, Male, run by Institut Claudius Regaud at 11 sites in France.
Trial summary
The purpose of this study is to determine whether association Gemcitabine-Cisplatin is effective in the treatment of penis epidermoid carcinoma loco-regionally advanced or metastatic. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Genital Neoplasms, Male
- What is being tested?
- Gemcitabine and Cisplatin
- Type of treatment
- Injection or infusion
- How many people
- 50 participants
- Where
- 11 sitesFrance
- Study dates
- Feb 2004to Dec 2012
- 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
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥ 18 years
- OMS ≤ 2
- Penis epidermoid carcinoma histologically proved. Tumor with ganglionic loco-regional injury inextirpable and/or metastatic (M1, all T , all N), at initial diagnostic or at relapse after first treatment with curative aim (surgery and / or radiotherapy)
- Disease measurable with RECIST criteria
- Absence of all former chemotherapy during 5 years between inclusion.
- If former radiotherapy, necessity to have appreciated targets outside the irradiation fields. If former radiotherapy, it must have been done more than 4 weeks before inclusion in the study.
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- Biologicals values required : polynuclear neutrophils ≥ 1500/mm3, blood-platelets ≥ 100000/mm3, Hb ≥ 10 g/dl, Transaminases < 3N, TP ≥ 70%, total bilirubin < 1,5 N, creatinine in the blood ≤ 110 micromoles/l.
- Normal clearance of creatinine, according to Cockroft and Gault's formulae.
- Calcemia : normal or anomaly without clinical meaning.
- Well-informed written consent, signed by the patient.
Who cannot join
- Uncontrolled cerebral known metastasis
- All former chemotherapy administration during 5 years between inclusion
- Other cancer (except baso-cellular cancer of skin correctly treated, or cancerous disease considered with good prognosis and on remission until 5 years at least)
- Uncontrolled cardiac insufficiency or all other severe and uncontrolled pathology.
- Peripheric neuropathy ≥ grade 2 OMS
- Anormal audiogram
- Patient difficult to follow for geographical, psychological or family reasons.
- Persons protected by law.
Trial locations and contacts
11 sites in 1 country.
11 sites in 1 country
France11 sites
Centre Paul Papin
Angers
Institut Bergonie
Bordeaux
Centre François Baclesse
Caen
CHU Grenoble
Grenoble
Centre Léon Bérard
Lyon
Institut Paoli Calmette
Marseille
Institut Val d'aurelle
Montpellier
Institut Curie
Paris
Centre Eugène Marquis
Rennes
Centre Médico-Chirurgical Foch
Suresnes
Institut Claudius Regaud
Toulouse
About this study
Official title: Phase 2 Study for Treatment of Penis Epidermoid Carcinoma Loco-regionally Advanced or Metastatic by Association Gemcitabine-Cisplatin
The purpose of this study is to determine whether association Gemcitabine-Cisplatin is effective in the treatment of penis epidermoid carcinoma loco-regionally advanced or metastatic.
- Conditions
- Genital Neoplasms, Male
- Being tested
- Gemcitabine, Cisplatin
- Keywords
- Genital Neoplasms, Male
- Medical subject headings
- Genital Neoplasms, Male
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GemcitabineDrug
Gemzar IV infusion 30 minutes Day 1/ Day 15 1250 mg/m²/j
CisplatinDrug
Cisplatin 50 mg/m²/day 1 h IV infusion at Day 1 / Day 15
What is being measured
The primary outcome is the main question the study is designed to answer.
To evaluate objective response rate
Measured: until desease progression
Secondary outcomes (3)
To evaluate tolerance of the association,
Measured: during all participation of the subject
time to progression,
Measured: untill progression
global survival
Measured: untill death
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2005 (estimated)
- Study startFeb 2004
- Primary completionDec 2011
- Study completionDec 2012
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 Genital Neoplasms, MaleStudies 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
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Institut Claudius Regaud
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Christine Chevreau, Doctor, Principal investigator, Institut Claudius Regaud
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00210041
- Sponsor's protocol ID
- 03 GENH 06
- Other IDs
- 02 GENM 02
- Status last verified
- May 2026
- First submitted
- 2 Sep 2005
- Last updated
- 15 May 2026
- Results posted
- No
Publications
Houede N, Dupuy L, Flechon A, Beuzeboc P, Gravis G, Laguerre B, Theodore C, Culine S, Filleron T, Chevreau C. Intermediate analysis of a phase II trial assessing gemcitabine and cisplatin in locoregional or metastatic penile squamous cell carcinoma. BJU Int. 2016 Mar;117(3):444-9. doi: 10.1111/bju.13054. Epub 2015 Apr 27.
PubMed 25601543
Study at a glance
From the registry record, last updated by the sponsor on 15 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 2 Study for Treatment of Penis Epidermoid Carcinoma Loco-regionally Advanced or Metastatic by Association Gemcitabine-Cisplatin
- ClinicalTrials.gov ID
- NCT00210041
- Acronym / sponsor ID
- 03 GENH 06
- Conditions
- Genital Neoplasms, Male
- Keywords
- Genital Neoplasms, Male
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Institut Claudius RegaudUniversity, hospital or other
- Study start
- Feb 2004
- Primary completion
- Dec 2011 (actual)
- Study completion
- Dec 2012 (actual)
- First posted
- 21 Sep 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.
The purpose of this study is to determine whether association Gemcitabine-Cisplatin is effective in the treatment of penis epidermoid carcinoma loco-regionally advanced or metastatic.
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
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Age ≥ 18 years
- OMS ≤ 2
- Penis epidermoid carcinoma histologically proved. Tumor with ganglionic loco-regional injury inextirpable and/or metastatic (M1, all T , all N), at initial diagnostic or at relapse after first treatment with curative aim (surgery and / or radiotherapy)
- Disease measurable with RECIST criteria
- Absence of all former chemotherapy during 5 years between inclusion.
Key exclusion criteria (8 listed)
- Uncontrolled cerebral known metastasis
- All former chemotherapy administration during 5 years between inclusion
- Other cancer (except baso-cellular cancer of skin correctly treated, or cancerous disease considered with good prognosis and on remission until 5 years at least)
- Uncontrolled cardiac insufficiency or all other severe and uncontrolled pathology.
- Peripheric neuropathy ≥ grade 2 OMS
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 |
|---|---|---|
| GemcitabineGemzar IV infusion 30 minutes Day 1/ Day 15 1250 mg/m²/j | Drug | – |
| CisplatinCisplatin 50 mg/m²/day 1 h IV infusion at Day 1 / Day 15 | Drug | – |
Primary outcome
To evaluate objective response rate
Time frame: until desease progression
3 secondary outcomes
To evaluate tolerance of the association,
Time frame: during all participation of the subject
time to progression,
Time frame: untill progression
global survival
Time frame: untill death
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 15 May 2026.
- Results publication: PubMed 25601543Houede N, Dupuy L, Flechon A, Beuzeboc P, Gravis G, Laguerre B, Theodore C, Culine S, Filleron T, Chevreau C. Intermediate analysis of a phase II trial assessing gemcitabine and cisplatin in locoregional or metastatic penile squamous cell carcinoma. BJU Int. 2016 Mar;117(3):444-9. doi: 10.1111/bju.13054. Epub 2015 Apr 27.
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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.
Christine Chevreau, Doctor principal investigator
Institut Claudius Regaud
11 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 Gemcitabine and Cisplatin in people with Genital Neoplasms, Male, run by Institut Claudius Regaud at 11 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 10 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: finished, as of the sponsor's last update on 15 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 11 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 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 evaluate objective response rate (time frame: until desease progression). 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 NCT00210041, 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 15 May 2026.