"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

Centre Leon Berard

Adult and pediatric patients with newly diagnosed acute myeloid leukemia, both eligible and not eligible for intensive chemotherapy. Since this is a non-interventional study, therapeutic strategies remains related to local guidelines. Will be treated as cases all patients with acute leukemia in first induction developing an Invasive Fungal Infection according to international EORTC criteria for possible/probable/proven infections. Patients who do not develop the infection will be used as a control group.

Acute Myeloid Leukemia

Aspergillosis

Candidiasis

Mycoses

University of Ancona

University of Bary

University of Bologna

University of Firenze

Tricase Hospital

Niguarda Hospital

Catholic University

S.Camillo Hospital

S.Giovanni Hospital

University of Tor Vergata

Le Molinette Hospital

Hospital of Brescia

University of Cagliari

Cuneo Hospital

Istotuto Meyer

Gaslini Hospital

La Spezia Hospital

Lecce Hospital

Lecce Pediatric Hospital

University of Modena e Reggio

Monza Hospital

San Gerardo Hospital

"Federico II" University

Cardarelli Hospital

Pausilion Hospital

University of Palermo

University of Parma

S.Matteo Hospital, Department of Hematology

S.Matteo Hospital, Department of Medicine

University of Perugia, Pediatric Hematology

University of Perugia

Pescara Hospital

Reggio Calabria Hospital

Reggio Emilia Hospital

"Padre Pio" Hospital

Regina Margherita Hospital

S.Anna Hospital

University of Udine

University of Verona

Verona Hospital

Pre-hospital Risk Factors for Invasive Fungal Infection

SEIFEM 2010: Epidemiological Survey on Possible Pre-Hospital Risk Factors for Developing Invasive Fungal Infections in Patients Affected by Acute Myeloid Leukemia

To identify possible fungal infections sources for the period preceding the diagnosis of leukemia, in particular those related to normal activities of daily life (e.g. occupation, location and type of residence, consume of tobacco, alcohol or illicit drugs and others).

Livio Pagano, MD

Catholic University of the Sacred Heart

neutropenia

nicotine

neutropenia/nicotine

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

Pre-hospital Risk Factors for Invasive Fungal Infection

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