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

NCT07361133 | Not Yet Recruiting Phase 2 DMC

• 1 other identifier: MO 2504-505-120-198
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Squamous Cell Carcinoma; Advanced Head and Neck Cancer

Keywords

Cyclophosphamide; Etoposide; Head and neck squamous cell carcinoma; Metastatic; Advanced; Recurrent

Outcome Measures

Primary Outcomes (1)

• The efficacy of Cyclophosphamide and Etoposide as metronomic therapy

  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.

  From first day of the study to the end of treatment at 6 months.

Secondary Outcomes (3)

• Assessment of clinical symptoms

  From the first day of the study till the end of treatment at 6 months

• Progression free survival

  From first day of the study till the end of study at 6 months

• Overall survival

  From the first day of study till the end of study at 8 months

Study Arms (2)

Cyclophosphamide and Etoposide in combination

EXPERIMENTAL

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.

Drug: Cyclophosphamide and Etoposide in combination

Methotrexate

ACTIVE COMPARATOR

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

Drug: Methotrexate

Interventions

Methotrexate DRUG

50 mg weekly for 6 months

Methotrexate

Cyclophosphamide and Etoposide in combination DRUG

Cyclophosphamide IV 400 mg/m2 every 3 weeks and etoposide 100 mg/m2 daily for 3 days every 4 weeks for 6 months.

Cyclophosphamide and Etoposide in combination

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• National Cancer Institute, Egypt: lead

Study Sites (1)

National Cancer Institute

Cairo, Cairo Governorate, 11796, Egypt

Location

Related Links

• Related Info

MeSH Terms

Conditions

Carcinoma, Squamous Cell; Head and Neck Neoplasms; Squamous Cell Carcinoma of Head and Neck; Neoplasm Metastasis; Recurrence

Interventions

Cyclophosphamide; Etoposide; Methotrexate

Condition Hierarchy (Ancestors)

Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Squamous Cell; Neoplasms by Site; Neoplastic Processes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Disease Attributes

Intervention Hierarchy (Ancestors)

Phosphoramide Mustards; Nitrogen Mustard Compounds; Mustard Compounds; Hydrocarbons, Halogenated; Hydrocarbons; Organic Chemicals; Phosphoramides; Organophosphorus Compounds; Podophyllotoxin; Tetrahydronaphthalenes; Naphthalenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Polycyclic Compounds; Glucosides; Glycosides; Carbohydrates; Aminopterin; Pterins; Pteridines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Central Study Contacts

Mahitab Gamal

CONTACT

00201119668735; mahitab2526@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 4, 2025
• First Posted: January 22, 2026
• Study Start: April 1, 2026
• Primary Completion (Estimated): August 1, 2026
• Study Completion (Estimated): September 1, 2026
• Last Updated: April 16, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)