New drug combo shows promise for rare penile cancer
NCT ID NCT00210041
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tested whether a combination of two chemotherapy drugs, gemcitabine and cisplatin, can shrink tumors in people with advanced or metastatic penile cancer. Fifty adults with inoperable or spreading disease took part. The main goal was to see how many patients responded to the treatment, while also monitoring side effects and how long the benefit lasted.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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About 50 people
The number the study aims to enrol. It can still change while the study runs.
- Start date
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Feb 2004
- Finished
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Dec 2012
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Male participants only
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * 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. * 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. Exclusion Criteria: * 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.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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CHU Grenoble
Grenoble, France
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Centre Eugène Marquis
Rennes, France
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Centre François Baclesse
Caen, France
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Centre Léon Bérard
Lyon, France
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Centre Médico-Chirurgical Foch
Suresnes, France
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Centre Paul Papin
Angers, France
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Institut Bergonie
Bordeaux, France
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Institut Claudius Regaud
Toulouse, France
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Institut Curie
Paris, France
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Institut Paoli Calmette
Marseille, France
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Institut Val d'aurelle
Montpellier, France
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