NCT02524275

Docetaxel and Capecitabine With Recurrent or Metastatic Squamous Cell Carcinoma of the Head and Neck

Phase II Study of Docetaxel and Capecitabine in Advanced Squamous Cell Carcinoma of the Head and Neck

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 14 (actual)
• Sponsor: University of Nebraska · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This phase II trial studies the side effects and how well docetaxel and capecitabine work in treating patients with squamous cell (thin, flat cells) carcinoma of the head and neck that has come back or spread to other places in the body. Drugs used in chemotherapy, such as docetaxel and capecitabine, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading.

Detailed description

PRIMARY OBJECTIVES: I. To evaluate in a phase II study the efficacy (the radiographic assessment of disease status after 2 cycles of therapy) of a combination of docetaxel and capecitabine in subjects with advanced squamous cell carcinoma of the head and neck who are not candidates for surgery or radiation therapy. II. To evaluate the safety and toxicities of docetaxel and capecitabine in subjects with advanced squamous cell carcinoma of the head and neck. III. To descriptively examine the effects of the combination of docetaxel and capecitabine on the quality of life of subjects with advanced squamous cell carcinoma of the head and neck. OUTLINE: Patients receive docetaxel intravenously (IV) over 1 hour on day 1 and capecitabine orally (PO) twice daily (BID) on days 1-14. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed up for 30 days and then periodically thereafter.

Conditions

• Head and Neck Squamous Cell Carcinoma

Interventions

Type	Name	Description
DRUG	Capecitabine	Given PO
DRUG	Docetaxel	Given IV
OTHER	Quality-of-Life Assessment	Ancillary studies
OTHER	Questionnaire Administration	Ancillary studies

Timeline

• Start date: 2015-03-30
• Primary completion: 2021-10-28
• Completion: 2021-10-28
• First posted: 2015-08-14
• Last updated: 2023-09-08
• Results posted: 2022-09-01

Locations

3 sites across 1 country: United States

Regulatory

• FDA-regulated drug study