Ph II Study Examining Long Term/Low Dose Xeloda in Head and Neck Squamous Cell Carcinoma After Surgery, Radiation &/or Chemotherapy
RATIONALE: Drugs used in chemotherapy, such as capecitabine, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving capecitabine after surgery, radiation therapy, and/or chemotherapy may kill any remaining tumor cells.
PURPOSE: This phase II trial is studying how well capecitabine works in treating patients who have undergone previous surgery, radiation therapy, and/or chemotherapy for head and neck cancer.
Head and Neck Cancer
Procedure: Surgery, chemotherapy and/or radiotherapy
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Phase II Study Examining the Feasibility of Long Term and Low Dose Oral Capecitabine (Xeloda®) in Newly Diagnosed Head and Neck Squamous Cell Carcinoma (HNSCC) After Surgery, Radiation and/or Chemotherapy|
- Feasibility of Treatment as Assessed. [ Time Frame: within 365 days ] [ Designated as safety issue: No ]Compliance was taking at least 80% of the prescribed dose for one year.
- Time to Recurrence [ Time Frame: assessed from time of study entry until documented ] [ Designated as safety issue: No ]
- Local-regional Control Rate Occurrence [ Time Frame: within 365 days ] [ Designated as safety issue: No ]
- Survival Rate [ Time Frame: from time of study entry until death ] [ Designated as safety issue: No ]
- Incidence of Second Primary Tumor Occurrence [ Time Frame: Every 12 months ] [ Designated as safety issue: Yes ]
|Study Start Date:||December 2003|
|Study Completion Date:||February 2011|
|Primary Completion Date:||February 2011 (Final data collection date for primary outcome measure)|
Surgery, chemotherapy and/or radiotherapy, prior to administration of Capecitabine 1000mg/day for one year.
Capecitabine 1000mg/day for one year
Other Name: XelodaProcedure: Surgery, chemotherapy and/or radiotherapy
Surgery, chemotherapy and/or radiotherapy
Other Name: Surgery, chemotherapy and/or radiotherapy
- Determine the feasibility of adjuvant low-dose capecitabine in patients with squamous cell carcinoma of the head and neck who have undergone prior curative surgery, radiotherapy, and/or chemotherapy.
- Determine the time to recurrence, local-regional control, and survival rate in patients treated with this drug.
- Determine the incidence of second primary tumors in patients treated with this drug.
OUTLINE: This is an open-label study.
Patients receive oral capecitabine once daily for 1 year in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed every 3 months for 1 year and then every 6 months for 1 year.
PROJECTED ACCRUAL: A total of 41 patients will be accrued for this study.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00258310
|United States, Michigan|
|Barbara Ann Karmanos Cancer Institute|
|Detroit, Michigan, United States, 48201-1379|
|Study Chair:||George H. Yoo, MD||Barbara Ann Karmanos Cancer Institute|