Clinical trial NCT00258310: Ph II Long Term/Low Dose Xeloda in Head and Neck Squamous Cell Carcinoma After Surgery, Radiation & or Chemo
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Head and Neck Cancer
Keywords: 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
Lead sponsor: Barbara Ann Karmanos Cancer Institute
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2005-11-24
Enrollment: 35
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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.

Detailed 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.

Eligibility 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

* 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

Primary outcomes:
measure: Compliance With Treatment .
timeFrame: within 365 days
Secondary outcomes:
measure: Recurrence-free Survival
timeFrame: Within 3 years of end of study.
measure: Overall Survival
timeFrame: Within 3 years of end of study
measure: Incidence of Second Primary Tumors
timeFrame: Within 3 years of end of study
Other outcomes:
Locations:
city: Detroit
country: United States
facility: Barbara Ann Karmanos Cancer Institute
state: Michigan
Study officials:
affiliation: Barbara Ann Karmanos Cancer Institute
name: George H. Yoo, MD
role: STUDY_CHAIR
References: