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

NCT02014831 · Status: WITHDRAWN · Phase: PHASE2 · Type: INTERVENTIONAL

Last updated 2016-02-25

No results posted yet for this study

Summary

The purpose of this study is to evaluate the efficacy and safety of Cetuximab in metastatic penile carcinoma

Conditions

  • Squamous Cell Carcinoma of the Penis

Interventions

DRUG

Cetuximab

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

DRUG

TIP

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

Sponsors & Collaborators

  • Centre Leon Berard

    lead OTHER

Principal Investigators

  • Helen BOYLE, Doctor · Centre Leon Berard

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-02-29
Primary Completion
2016-02-29
Completion
2016-02-29

Countries

  • France

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02014831 on ClinicalTrials.gov