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

Condition(s) studied

Investigational drug(s) / intervention(s)

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.

Methotrexate: 50 mg weekly for 6 months

Study 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.

Eligibility

Primary outcome measure(s)

• The efficacy of Cyclophosphamide and Etoposide as metronomic therapy — From first day of the study to the end of treatment at 6 months.
  The efficacy of Cyclophosphamide and Etoposide as metronomic therapy in improving disease response. Tumor size (tumor dimensions: length, width, height) as measured by Computed Tomography, illustrating whether the disease is progressed, regressed or stationary. In addition to serum LDH level. Both will be assessed every 3 cycles.

Trial sites (1)

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