NCT00258310 · REGISTRY CONDITION SEARCH

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

Found through the registry condition index, not selected as a treatment recommendation. This discovery collection was restricted to studies with posted results.

Phase: PHASE2
Status at capture: COMPLETED
Registry last update: 2023-03-10

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.

Open the original ClinicalTrials.gov record → · Download preserved record

What did the study report?

Outcomes, safety and baseline populations are separate source sections. Quality-of-life measures appear under their original outcome titles.

flow

Participant flow

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baseline

Baseline characteristics

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outcome · POSTED

Compliance With Treatment .

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outcome · POSTED

Recurrence-free Survival

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outcome · POSTED

Overall Survival

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outcome · POSTED

Incidence of Second Primary Tumors

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adverse events

Adverse events

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more info

Limitations, agreements, and source contact

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Who could take part

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
healthy Volunteers: false
minimum Age: 18 Years
sex: ALL
std Ages: ADULT
OLDER_ADULT

Treatment arms and interventions

arm Groups

description
Surgery, chemotherapy and/or radiotherapy, prior to administration of Capecitabine 1000mg/day for one year.
intervention Names
Drug: capecitabine
Procedure: Surgery, chemotherapy and/or radiotherapy
label
Capecitabine
type
EXPERIMENTAL

interventions

arm Group Labels
Capecitabine
description
Capecitabine 1000mg/day for one year
name
capecitabine
other Names
Xeloda
type
DRUG
arm Group Labels
Capecitabine
description
Surgery, chemotherapy and/or radiotherapy
name
Surgery, chemotherapy and/or radiotherapy
type
PROCEDURE

Study design

allocation

intervention Model

SINGLE_GROUP

masking Info

masking: NONE

primary Purpose

TREATMENT

Enrollment

count: 35
type: ACTUAL

Registered outcome plans (not posted results)

primary Outcomes

description
Compliance is defined as taking at least 80% of the prescribed dose for one year.
measure
Compliance With Treatment .
time Frame
within 365 days

secondary Outcomes

description
Time to recurrence or death
measure
Recurrence-free Survival
time Frame
Within 3 years of end of study.
description
Estimated time from study entry to death from any cause
measure
Overall Survival
time Frame
Within 3 years of end of study
measure
Incidence of Second Primary Tumors
time Frame
Within 3 years of end of study

Full study description

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.

Source references