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

National Cancer Institute, Egypt

Status and phase: Not yet enrolling; Phase 2

Conditions: Advanced Head and Neck Squamous Cell Carcinoma; Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma

Treatments: Drug: Methotrexate; Drug: Cyclophosphamide and Etoposide in combination

Study type: Interventional

Funder types: Other

Identifiers

NCT07361133

MO 2504-505-120-198

Details and patient eligibility

About

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.

Full 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.

Enrollment: 120 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Adult participants, age = or > 18 years
• Participants with recurrent head and neck squamous cell carcinoma after failure on first line chemotherapy.
• Participants with advanced progressed, resistant, metastatic head and neck squamous cell carcinoma.

Exclusion criteria

• Adjuvant and Neoadjuvant head and neck squamous cell carcinoma patients.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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120 participants in 2 patient groups

Cyclophosphamide and Etoposide in combination

Experimental group

Description:

Participants in intervention arm will receive cyclophosphamide IV 400 mg/m2 every 3 weeks and etoposide 100 mg/m2 daily for 3 days every 4 weeks, for total 6 months.

Treatment:

Drug: Cyclophosphamide and Etoposide in combination

Methotrexate

Active Comparator group

Description:

Participants in control arm will receive weekly Methotrexate 50 mg for total 6 months.

Treatment:

Drug: Methotrexate