"Reference" arm; Patients will be treated with 6 cycles of Paclitaxel + Ifosfamide + Cisplatin (TIP treatment)

"Experimental" arm: Patients will be treated with 6 cycles of Paclitaxel + Ifosfamide + Cisplatin (TIP treatment) and weekly infusion of Cetuximab.

Squamous Cell Carcinoma of the Penis

Cetuximab treatment will be administered on specific days within a 21-days-cycle and for a maximum of 6 cycles as follow :
CETUXIMAB I.V infusion of 400 mg/m2 on cycle 1 Day 0 for 2 hours, then 250 mg/m2 for subsequent infusions for 1 hour on Day 8, Day 15 and next cycles Day1, Day8, Day15.
In case of documented toxicities, 2 drugs doses reductions are allowed according specific algorithms indicated in protocol

Cetuximab

The TIP combination of treatments will be administered on specific days within a 21-days-cycle and for a maximum of 6 cycles as follow :
PACLITAXEL I.V infusion of 175 mg/m2, for 3 hours, on Day 1 of the cycle.
IFOSFAMIDE I.V infusion of 1200 mg/m2, for 2 hours, on Day 1, Day 2, Day 3 of the cycle.
CISPLATINE I.V infusion of 25 mg/m2, for 1 hour, on Day 1, Day 2, Day 3.
In case of documented toxicities, 2 drugs doses reductions are allowed according specific algorithms indicated in protocol

CHRU Strasbourg

Institut Paoli Calmettes

Institut Bergonié

Institut Claudius Regaud

Institut Curie

APHP Hôpital Saint Louis

Centre Léon Bérard

Efficacy and Safety of Cetuximab in Metastatic Penile Carcinoma (PENILANE)

A Randomized Phase II Study to Evaluate the Efficacy and Safety of Cetuximab in Metastatic Penile Carcinoma

Patients will be treated by TIP +/- Cetuximab for 1 cycle of 21 days. Subsequent treatment cycles will be performed only if patients meet correct biological analyses as defined by protocol, with a maximum of 5 more cycles of 21 days. Thus, the treatment duration will vary between patients from 3 weeks to 18 weeks. The treatment efficacy will be evaluated 28 days after the day 1 of the last cycle administered. Thus ORR will be evaluated between 4 weeks to 20 weeks after randomization, according to the amount of administered cycles.
ORR is defined as the proportion of patients with best response consisting in a Complete Response (CR) or a Partial Response (PR) from the date of randomization to the date of the end of treatment visit (i.e 6 cycles of treatment as maximum) evaluated according to the Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1

Safety profile is assessed throughout the study by incidence and intensity of Adverse Events displayed by patients using the CTCAE version 4.0

OS is defined as the time from the date of randomization to the date of death due to any cause. If a patient is not known to have died at the time of the analysis, OS will be censored at the date of last contact.

PFS is defined as the time from the date of randomization to the date of event defined as the first documented progression or death due to any cause. If a patient has not had an event at the time of the analysis, PFS will be censored at the date of last adequate tumor assessment.

Quality of life is assessed using the European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ) C30. It will be evaluated at Screening, at the beginning of cycle 4, and at the end of treatment i.e after 6 cycles maximum

penile neoplasms/никотин

Efficacy and Safety of Cetuximab in Metastatic Penile Carcinoma (PENILANE)

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