Conditions: Penile Squamous Cell Carcinoma (PSCC)
Keywords: Epidermal growth factor receptor (EGFR), Human Papillomavirus (HPV) Penile squamous cell carcinoma (PSCC) Gilotrif
Allocation: NA | Intervention model: SINGLE_GROUP
Enrollment: 8
Healthy volunteers: no

Brief summary:
Penile squamous cell carcinoma (PSCC) is a highly aggressive and relatively rare disease. Supportive evidence for the value of systemic therapy does not exist for this disease and there are no agents currently approved by regulatory agencies. This study will evaluate the drug Gilotrif in patients with metastatic progressive PSCC following chemotherapy. Gilotrif has shown supportive evidence in non-small cell lung cancer by inhibiting certain proteins that are also found in PSCC. The drug has the potential for some patients to exhibit a response contributing to a greater quality of life.

Detailed description:
This is a non-randomized trial phase 2 trial in which the drug Gilotrif will be administered at an oral dosage of 40 mg daily. This will continue until there is disease progression or severe toxicities. Patients will undergo a clinical exam every 4 weeks as well as have blood collected. Radiographic scans will be done every 8 weeks.

Arms:
arm 1: Gilotrif will be administered orally at 40 mg dosage once daily. Continuous administration of 4 weeks is considered one cycle. Therapy will continue until progression of the disease or severe toxicities. Labs will be monitored with routine blood collections every cycle and a CT scan will be done every two cycles (8 weeks).

Interventions: intervention 1: Gilotrif
Intervention descriptions: intervention 1: Patients will take a single oral dose of Gilotrif each day starting at 40 mg. Dose escalation and reductions can occur.

Protocol document:
Prot_SAP_ICF_000.pdf: