Afatinib for Advanced Skin Cancer
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial explores whether Afatinib, a daily medication, can treat advanced skin cancer, specifically cutaneous squamous cell carcinoma (cSCC), which cannot be treated with further surgery or radiation. Participants will take Afatinib and undergo regular check-ups, including scans and biopsies, to assess the treatment's effectiveness. Those with cSCC that has spread or cannot be surgically removed, and who have already tried other treatments like immunotherapy, may be suitable candidates. As a Phase 2 trial, the research focuses on measuring the treatment's effectiveness in an initial, smaller group of people.
Do I need to stop my current medications to join the trial?
The trial protocol does not specify if you need to stop taking your current medications. However, you must be at least 2 weeks from any prior systemic therapy before starting the study treatment.
Is there any evidence suggesting that Afatinib is likely to be safe for humans?
Research shows that afatinib, a cancer treatment, can cause some side effects. Studies have found that patients might experience skin rash, diarrhea, and other skin problems. Some reports also mention a loss of appetite, nausea, and vomiting.
However, afatinib is already approved for other uses, indicating it is generally safe when used properly. Awareness of these side effects can aid in better management. Considering these factors is important when deciding to join a trial.12345Why do researchers think this study treatment might be promising?
Unlike most treatments for advanced skin cancer, which typically involve chemotherapy or targeted therapies against specific mutations, afatinib is a pan-ErbB inhibitor. This means it targets multiple receptors in the ErbB family, potentially offering broader anti-cancer effects. Researchers are excited about afatinib because it may work for patients whose tumors have not responded to other treatments by attacking cancer cell growth through a different pathway. Additionally, its once-daily oral administration offers a convenient alternative to more invasive treatment methods.
What evidence suggests that Afatinib might be an effective treatment for advanced skin cancer?
Research has shown that Afatinib may help treat certain cancers. In studies with non-small cell lung cancer (NSCLC), Afatinib stopped the cancer from worsening for about 7.3 months on average. Earlier research also found that it controlled the disease in 87.6% of NSCLC patients and shrank tumors in 58.9% of them. Afatinib blocks specific proteins that aid cancer cell growth. This trial will investigate whether Afatinib might also be effective in treating advanced skin cancer similarly.678910
Who Is on the Research Team?
Zeynep Eroglu
Principal Investigator
Moffitt Cancer Center
Are You a Good Fit for This Trial?
Adults with advanced cutaneous squamous cell carcinoma (cSCC) not suitable for surgery/radiation, who've had prior immunotherapy if eligible. Must have good organ function and performance status, a measurable lesion, and be at least 2 weeks post any major treatment or surgery. Those with treated brain metastases can join; however, those with severe liver issues, mixed cancer types, untreated HIV/HCV or pregnancy are excluded.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive afatinib 40 mg once a day. Each cycle is 4 weeks. CT imaging and/or digital photography is done at baseline and every 8 weeks. Tumor biopsies are conducted at baseline, at 4 weeks, and at disease progression if feasible.
Follow-up
Participants are monitored for safety and effectiveness after treatment, including assessment of treatment-related adverse events up to 40 days after end of treatment.
Long-term follow-up
Participants are monitored for progression-free survival and overall survival.
What Are the Treatments Tested in This Trial?
Interventions
- Afatinib
Afatinib is already approved in United States, European Union, Canada, Japan for the following indications:
- Non-small cell lung cancer
- Non-small cell lung cancer
- Non-small cell lung cancer
- Non-small cell lung cancer
Find a Clinic Near You
Who Is Running the Clinical Trial?
H. Lee Moffitt Cancer Center and Research Institute
Lead Sponsor
Boehringer Ingelheim
Industry Sponsor