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

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

Status
Completed
Phases
Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00258310
Enrollment
35
Registered
2005-11-24
Start date
2003-12-31
Completion date
2011-02-28
Last updated
2023-03-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

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

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.

Interventions

DRUGcapecitabine

Capecitabine 1000mg/day for one year

PROCEDURESurgery, chemotherapy and/or radiotherapy

Surgery, chemotherapy and/or radiotherapy

Sponsors

National Cancer Institute (NCI)
CollaboratorNIH
Barbara Ann Karmanos Cancer Institute
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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 * 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

Design outcomes

Primary

MeasureTime frameDescription
Compliance With Treatment .within 365 daysCompliance is defined as taking at least 80% of the prescribed dose for one year.

Secondary

MeasureTime frameDescription
Recurrence-free SurvivalWithin 3 years of end of study.Time to recurrence or death
Overall SurvivalWithin 3 years of end of studyEstimated time from study entry to death from any cause
Incidence of Second Primary TumorsWithin 3 years of end of study

Countries

United States

Participant flow

Participants by arm

ArmCount
Capecitabine
Capecitabine 1000mg/day for one year capecitabine adjuvant therapy
35
Total35

Baseline characteristics

CharacteristicCapecitabine
Age, Continuous58 years
Region of Enrollment
United States
35 participants
Sex: Female, Male
Female
7 Participants
Sex: Female, Male
Male
28 Participants

Adverse events

Event typeEG000
affected / at risk
deaths
Total, all-cause mortality
— / —
other
Total, other adverse events
3 / 35
serious
Total, serious adverse events
2 / 35

Outcome results

Primary

Compliance With Treatment .

Compliance is defined as taking at least 80% of the prescribed dose for one year.

Time frame: within 365 days

ArmMeasureValue (NUMBER)
CapecitabineCompliance With Treatment .74 percentage of participants
95% CI: [0.59, 0.9]
Secondary

Incidence of Second Primary Tumors

Time frame: Within 3 years of end of study

Population: Entire study population

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
CapecitabineIncidence of Second Primary Tumors3 Participants
Secondary

Overall Survival

Estimated time from study entry to death from any cause

Time frame: Within 3 years of end of study

Population: Entire study population

ArmMeasureValue (MEDIAN)
CapecitabineOverall SurvivalNA months
Secondary

Recurrence-free Survival

Time to recurrence or death

Time frame: Within 3 years of end of study.

Population: All enrolled participants

ArmMeasureValue (MEDIAN)
CapecitabineRecurrence-free SurvivalNA months

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026