Ph II Long Term/Low Dose Xeloda in Head and Neck Squamous Cell Carcinoma After Surgery, Radiation & or Chemo

Head and Neck Cancer Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00258310
• Other study ID #: 2688
• Secondary ID: P30CA022453WSU-D
• Status: Completed
• Phase: Phase 2
• Start date: December 2003
• Est. completion date: February 2011

Study information

• Verified date: March 2023
• Source: Barbara Ann Karmanos Cancer Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

OBJECTIVES: Primary - 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. Secondary - 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 35
• Est. completion date: February 2011
• Est. primary completion date: February 2011
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

DISEASE CHARACTERISTICS:

• Histologically confirmed squamous cell carcinoma of the head and neck, including 1 of

the following primary tumor sites:

• Oral cavity
• Oropharynx
• Nasopharynx
• Hypopharynx
• Larynx
• Unknown primary
• Any disease stage allowed
• No evidence of active disease
• Must have undergone curative surgical resection, radiotherapy, and/or chemotherapy at least 1 month, but no more than 4 years ago PATIENT CHARACTERISTICS: Performance status
• Karnofsky 70-100% Life expectancy
• More than 3 months Hematopoietic
• White blood count (WBC) = 3,000/mm^3
• Granulocyte count = 1,500/mm^3
• Platelet count = 100,000/mm^3 Hepatic
• Bilirubin = 1.5 times upper limit of normal (ULN)
• Aspartate Aminotransferase (AST) or Alanine Aminotransferase (ALT) = 2.5 times ULN
• Alkaline phosphatase = 2.5 times ULN
• Hepatitis B and/or C negative Renal
• Creatinine clearance > 50 mL/min Cardiovascular
• No myocardial infarction within the past 12 months
• No uncontrolled congestive heart failure
• No unstable or uncontrolled angina Gastrointestinal
• No lack of physical integrity of the upper gastrointestinal tract
• Must be able to swallow tablet
• No malabsorption syndrome Other
• Not pregnant or nursing
• Negative pregnancy test
• Fertile patients must use effective contraception
• HIV negative
• No other malignancy within the past 5 years except adequately treated basal cell or squamous cell skin cancer, carcinoma in situ of the cervix, or stage I or II cancer for which the patient is currently in complete remission
• No history of uncontrolled seizures, central nervous system (CNS) disorders, or psychiatric disability that would preclude study compliance or giving informed consent
• No ongoing postoperative fistula
• No prior unanticipated severe reaction to fluoropyrimidine therapy or known sensitivity to fluorouracil
• No other serious uncontrolled medical or surgical condition that would preclude study participation PRIOR CONCURRENT THERAPY: Chemotherapy
• See Disease Characteristics
• Prior oral fluoropyrimidine therapy allowed provided it was given in the adjuvant setting and completed = 12 months ago Radiotherapy
• See Disease Characteristics Surgery
• See Disease Characteristics
• More than 4 weeks since prior major surgery and recovered
• No prior organ allografts Other
• More than 4 weeks since prior participation in any investigational drug study

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Squamous Cell
• Head and Neck Cancer
• Squamous Cell Carcinoma of Head and Neck

Intervention

Drug:
• capecitabine
Capecitabine 1000mg/day for one year

Procedure:
• Surgery, chemotherapy and/or radiotherapy
Surgery, chemotherapy and/or radiotherapy

Locations

Country	Name	City	State
United States	Barbara Ann Karmanos Cancer Institute	Detroit	Michigan

Sponsors (2)

Lead Sponsor	Collaborator
Barbara Ann Karmanos Cancer Institute	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Compliance With Treatment .	Compliance is defined as taking at least 80% of the prescribed dose for one year.	within 365 days
Secondary	Recurrence-free Survival	Time to recurrence or death	Within 3 years of end of study.
Secondary	Overall Survival	Estimated time from study entry to death from any cause	Within 3 years of end of study
Secondary	Incidence of Second Primary Tumors		Within 3 years of end of study

External Links

•   Clinical trial summary from the National Cancer Institute's PDQ® database