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

Study Status: Withdrawn
Recruit Status: Withdrawn
Study Type: Interventional

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

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

Detailed Summary:

Penile carcinoma is a rare cancer type, particularly in our industrialized countries. Incidence is not well established but is estimated around 26000 annual new cases all around the world [1]. We don't have accurate estimation for France but regarding data from the literature, incidence rates in developed countries vary from 0.7 to 1.0/100000 men [2]. The mean age at diagnosis is about 60 years [3].

Different causes have been identified like history of Human PapillomaVirus (essentially HPV16), phymosis, absence of circumcision, tobacco use, and history of condyloma [1]. In addition, a lot of molecular genetic alterations are also responsible for penile cancer occurrence and development [4].

Histologically, most of these tumors are epidermoid cancers. Tumor spreads into inguinal lymphnodes, then into pelvic lymphnodes. Then retroperitoneal lymphnodes are involves before metastatic dissemination, often in lungs, liver and bones.

According to the French urology recommendations, treatment of localized penis cancer should be conservative, as far as possible [5]; Even if local recurrences rate varies from 15% to 30% of patients, no reduction of overall survival is observed in these patients [7].

The investigations regarding involvement of inguinal lymphnodes and distant organs are a key-point. Among the 10% of patients with loco regional recurrence [6], lymphadenectomy should be preferred to chemotherapy which should be recommended for metastatic patients or unresectable patients with regional lymphnodes involvement [5].

Numbers of treatments (monotherapy or associations) have been tested in penis cancer but the rarity of these tumors is a major obstacle to clinical research, due t
Sponsor: Centre Leon Berard

Current Primary Outcome: Evaluation of the antitumor activity of Cetuximab treatment in terms of Objective Response Rate (ORR) at the end of treatment [ Time Frame: 4 weeks after the day 1 of the last cycle administered (i.e between 4 weeks to 20 weeks after randomization, according to the amount of administered cycles) ]

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



Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Evaluation of the Safety Profile of Cetuximab treatment [ Time Frame: From patient randomization up to the end of study i.e 28 months maximum after first patient inclusion ]
    Safety profile is assessed throughout the study by incidence and intensity of Adverse Events displayed by patients using the CTCAE version 4.0
  • Evaluation of the antitumor activity of Cetuximab treatment in terms of Overall Survival (OS) at the end of the study [ Time Frame: From patient randomization up to the end of study i.e 28 months maximum after first patient inclusion ]
    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.
  • Evaluation of the antitumor activity of Cetuximab treatment in terms of Progression-Free Survival (PFS) at the end of the study [ Time Frame: From patient randomization up to the end of study i.e 28 months maximum after first patient inclusion ]
    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.
  • Evaluation of Quality of Life during the Cetuximab treatment [ Time Frame: From patient randomization up to the end of treatment (i.e between 4 weeks to 20 weeks after randomization, according to the amount of administered cycles) ]
    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


Original Secondary Outcome: Same as current

Information By: Centre Leon Berard

Dates:
Date Received: December 5, 2013
Date Started: February 2016
Date Completion:
Last Updated: February 24, 2016
Last Verified: February 2016