Clinical Trials Directory

Trials / Withdrawn

WithdrawnNCT00095641

S0225 Capecitabine in Treating Patients Who Have Undergone Surgery for Locally Recurrent or Persistent Head and Neck Cancer

S0225: Phase II Study of Adjuvant Low-Dose Capecitabine After Salvage Surgery in Patients With Locally Recurrent or Persistent Squamous Cell Carcinoma of the Head and Neck

Status
Withdrawn
Phase
Phase 2
Study type
Interventional
Enrollment
0 (actual)
Sponsor
SWOG Cancer Research Network · Network
Sex
All
Age
18 Years
Healthy volunteers
Not accepted

Summary

RATIONALE: Drugs used in chemotherapy, such as capecitabine, work in different ways to stop tumor cells from dividing so they stop growing or die. Giving capecitabine after surgery may kill any remaining tumor cells. PURPOSE: This phase II trial is studying how well capecitabine works in treating patients who have undergone surgery for locally recurrent or persistenthead and neck cancer.

Detailed description

OBJECTIVES: * Determine 2-year disease-free survival of patients treated with surgical salvage followed by adjuvant low-dose capecitabine for locally recurrent or persistent squamous cell carcinoma of the head and neck . * Determine the toxic effects of this drug in these patients. * Determine 2-year overall survival of patients treated with this drug. * Determine patterns of disease relapse in patients treated with this drug. OUTLINE: This is a multicenter study. Patients receive oral capecitabine once daily for 12 months in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed periodically. PROJECTED ACCRUAL: A total of 70 patients will be accrued for this study within 2 years.

Conditions

Interventions

TypeNameDescription
DRUGcapecitabine
PROCEDUREadjuvant therapy
PROCEDUREchemotherapy

Timeline

First posted
2004-11-08
Last updated
2013-11-08

Source: ClinicalTrials.gov record NCT00095641. Inclusion in this directory is not an endorsement.