Clinical trial NCT03325738: Cetuximab for Unresectable Cutaneous Squamous Cell Carcinoma - A National Retrospective Study
Official title: Cetuximab for Unresectable Cutaneous Squamous Cell Carcinoma - A National Retrospective Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Squamous Cell Cutaneous Carcinoma of the Skin
Lead sponsor: Centre Antoine Lacassagne
Sponsor class: OTHER
First posted: 2017-10-30
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patient with a confirmed squamous cell cutaneous carcinoma of the skin, locally Advanced or metastatic and who received a monotherapy treatment by cetuximab

Brief summary: 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".


Eligibility criteria: 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.

Primary outcomes:
measure: Clinical Benefit of Cetuximab at 6 weeks
timeFrame: 6 weeks
Secondary outcomes:
measure: Objective response rate ORR
timeFrame: December 2017
measure: Overall survival OS
timeFrame: December 2017
measure: Progression free survival PFS
timeFrame: December 2017
measure: Cetuximab safety
timeFrame: December 2017
measure: Overall response delay
timeFrame: December 2017
measure: Disease stabilization delay
timeFrame: December 2017
measure: Best overall response BOR
timeFrame: December 2017
Other outcomes:
Locations:
city: Nice
country: France
facility: PEYRADE Frédéric
Study officials:
References: