NCT07361133

Cyclophosphamide and Etoposide as a Metronomic Therapy in Advanced Head and Neck Squamous Cell Cancer

Cyclophosphamide and Etoposide as a Promising Metronomic Therapy in Advanced Head and Neck Squamous Cell Carcinoma

• Status: Not Yet Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 120 (estimated)
• Sponsor: National Cancer Institute, Egypt · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The goal of this clinical trial is to learn if drugs as cyclophosphamide (C) and etoposide (E) work to treat advanced head and neck cancer in adults. It will also learn about the safety of both drugs. The main questions it aims to answer are: Do drugs C and E work to treat advanced head and neck cancer, after failure on first line chemotherapy? What medical problems do participants have when taking drugs C and E? Researchers will compare drugs C and E in combination to a placebo (a look-alike substance that contains no drug) to see if these 2 drugs works to treat advanced head and neck cancer. Participants will: Take drug C every 3 weeks and drug E every 4 weeks or a placebo every week for 6 months. Visit the clinic once every 3 weeks for checkups and tests. Keep a diary of their symptoms.

Detailed description

This clinical trial aims to evaluate the potential efficacy of cyclophosphamide and etoposide as metronomic therapy in recurrent/resistant and/or metastatic head and neck squamous cell carcinoma adults after failure on first line chemotherapy, or intolerant to further aggressive chemotherapy.

Conditions

• Squamous Cell Carcinoma
• Advanced Head and Neck Cancer

Interventions

Type	Name	Description
DRUG	Cyclophosphamide and Etoposide in combination	Cyclophosphamide IV 400 mg/m2 every 3 weeks and etoposide 100 mg/m2 daily for 3 days every 4 weeks for 6 months.
DRUG	Methotrexate	50 mg weekly for 6 months

Timeline

• Start date: 2026-04-01
• Primary completion: 2026-08-01
• Completion: 2026-09-01
• First posted: 2026-01-22
• Last updated: 2026-04-16

Locations

1 site across 1 country: Egypt