Squamous Cell Cutaneous Carcinoma of the Skin Clinical Trial
— C3Official title:
Cetuximab for Unresectable Cutaneous Squamous Cell Carcinoma - A National Retrospective Study
| NCT number | NCT03325738 |
| Other study ID # | 2017/05 |
| Secondary ID | |
| Status | Completed |
| Phase | |
| First received | |
| Last updated | |
| Start date | June 30, 2017 |
| Est. completion date | September 11, 2018 |
| Verified date | January 2019 |
| Source | Centre Antoine Lacassagne |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Observational |
Localized cutaneous squamous cell carcinoma (CSCC) is usually treated by radical surgery with
or without radiotherapy. The cure rate is high around 90% of cases (1). Unresectable CSCC
represents less than 10% of all CSCC. The prognosis of these advanced forms is poor, without
any proven treatment option. The number of studies investigating systemic treatment of
advanced or metastatic CSCC is limited, mostly based on phase II trials or case reports.
Systemic treatment includes cytotoxic chemotherapy such as cisplatin and 5-Fluoro-uracil
(5FU), immunotherapy (interferon alpha) or retinoic acid (13CRa) (1,2). Recently, epidermal
growth factor receptor (EGFR) targeting agents have been explored (1,2). The anti-EGFR
monoclonal antibody Cetuximab has shown some clinical efficacy in advanced CSCC alone or
concomitant with radiotherapy or chemotherapy (3-5). A recent phase II study aimed at
investigating the role of Cetuximab in 36 patients with unresectable CSCC (6). The authors
reported a disease control rate at 6 weeks of 69% (95% CI, 52% to 84%). The best responses
were eight partial responses and two complete responses. There were no Cetuximab-related
deaths. There were three related serious adverse events: two grade 4 infusion reactions and
one grade 3 interstitial pneumopathy. Grade 1 to 2 acne-like rash occurred in 78% of patients
and was associated with prolonged Progression Free Survival (PFS) (6). The authors concluded
that regarding the Cetuximab therapeutic index it could be interesting in this particular
situation mainly for elderly patient. Unfortunately, the small number of patient included not
allowed to draw definitive conclusion. It was interesting to note that the Disease rate
control (DRC) with Cetuximab increased of 15% comparatively of DRC with chemotherapy.
Additionally it seems that in case of efficacy the functional improvement of
Cetuximab-sensitive patients occurred after very few infusions.
Taking these data together it seemed logical to design a larger retrospective clinical trial
to confirm these results in "real life patients".
| Status | Completed |
| Enrollment | 60 |
| Est. completion date | September 11, 2018 |
| Est. primary completion date | June 30, 2017 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility |
Inclusion Criteria 1. Histologically Confirmed squamous cell cutaneous carcinoma of the skin (SCCS) 2. Locally advanced SCCS that is surgically unresectable, or metastatic SCCS, with documented progression, and who received a treatment of Cetuximab in monotherapy, 3. Patients have to be anti EGFR-naïve, 4. Age = 18 years 5. Eastern Cooperative Oncology Group performance status = 2; life expectancy = 3 months 6. Presence of at least one measurable target lesion, according to Response Evaluation Criteria in Solid Tumors (RECIST) criteria 7. Adequate hematologic, hepatic, and renal functions 8. Available medical data 9. Chemotherapy naïve patient in metastatic or locally advanced conditions (Cisplatinum used concomitantly with radiotherapy is allowed) Exclusion criteria 1. Prior radiotherapy within the last 4 weeks before the start of cetuximab (radiotherapy in concomitance with cetuximab is allowed if this is administrated in another lesion than the lesion treated by Cetuximab). 2. Prior therapy with an agent that targets EGFR 3. Instable systemic diseases or active uncontrolled infections. |
| Country | Name | City | State |
|---|---|---|---|
| France | PEYRADE Frédéric | Nice |
| Lead Sponsor | Collaborator |
|---|---|
| Centre Antoine Lacassagne |
France,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Clinical Benefit of Cetuximab at 6 weeks | To Assess the clinical benefit (complete response [CR], partial response [PR], or stable disease [SD]) after 6 weeks of treatment with Cetuximab | 6 weeks | |
| Secondary | Objective response rate ORR | The ORR will be defined as the sum of partial responses plus complete responses after 6 weeks of treatment with Cetuximab. | December 2017 | |
| Secondary | Overall survival OS | 2. The OS will be calculated between date of treatment beginning (Cetuximab) and the date of death for any reason. Patients who did not die at the time of analysis or are lost of follow-up will be censored at the date of the latest news. | December 2017 | |
| Secondary | Progression free survival PFS | The PFS will be calculated between date of treatment beginning (Cetuximab) and date of progression, death or starting another anticancer treatment. Patients who did not progress, did not die at the time of analysis or are lost of follow-up will be censored at the date of the latest news. | December 2017 | |
| Secondary | Cetuximab safety | The safety profile will be described using the common toxicity criteria from the NCI v4.03 and biological, including occurrence of acne-like rash. | December 2017 | |
| Secondary | Overall response delay | The DOR will be measured from the time measurement criteria are first met for CR/PR until the first date that progressive disease is objectively documented (without other anticancer treatment). | December 2017 | |
| Secondary | Disease stabilization delay | The DSD will be measured from the start of the treatment until the criteria for progression is objectively documented. | December 2017 | |
| Secondary | Best overall response BOR | The BOR will be recorded from the start of the treatment until the end of treatment taking into account any requirement for confirmation. | December 2017 |