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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 After Surgery, Radiation and/or Chemotherapy


Phase 2
18 Years
N/A
Not Enrolling
Both
Head and Neck Cancer

Thank you

Trial Information

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 After Surgery, Radiation and/or Chemotherapy


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.

Inclusion Criteria


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

- 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)

- AST or 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, 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

Type of Study:

Interventional

Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Feasibility of treatment as assessed within 365 days

Safety Issue:

No

Principal Investigator

George H. Yoo, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Barbara Ann Karmanos Cancer Institute

Authority:

United States: Federal Government

Study ID:

CDR0000445467

NCT ID:

NCT00258310

Start Date:

December 2003

Completion Date:

February 2011

Related Keywords:

  • Head and Neck Cancer
  • stage I squamous cell carcinoma of the hypopharynx
  • stage I squamous cell carcinoma of the larynx
  • stage I squamous cell carcinoma of the lip and oral cavity
  • stage I squamous cell carcinoma of the nasopharynx
  • stage I squamous cell carcinoma of the oropharynx
  • stage II squamous cell carcinoma of the hypopharynx
  • stage II squamous cell carcinoma of the larynx
  • stage II squamous cell carcinoma of the lip and oral cavity
  • stage II squamous cell carcinoma of the nasopharynx
  • stage II squamous cell carcinoma of the oropharynx
  • stage III squamous cell carcinoma of the hypopharynx
  • stage III squamous cell carcinoma of the larynx
  • stage III squamous cell carcinoma of the lip and oral cavity
  • stage III squamous cell carcinoma of the nasopharynx
  • stage III squamous cell carcinoma of the oropharynx
  • stage IV squamous cell carcinoma of the hypopharynx
  • stage IV squamous cell carcinoma of the larynx
  • stage IV squamous cell carcinoma of the lip and oral cavity
  • stage IV squamous cell carcinoma of the nasopharynx
  • stage IV squamous cell carcinoma of the oropharynx
  • Carcinoma, Squamous Cell
  • Head and Neck Neoplasms

Name

Location

Barbara Ann Karmanos Cancer InstituteDetroit, Michigan  48201