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

NCT ID: NCT00258310

Last Updated: 2023-03-10

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 35 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2003-12-31
• Study Completion Date: 2011-02-28

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.

Conditions

Head and Neck Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Capecitabine

Surgery, chemotherapy and/or radiotherapy, prior to administration of Capecitabine 1000mg/day for one year.

Group Type: EXPERIMENTAL

capecitabine

Intervention Type: DRUG

Capecitabine 1000mg/day for one year

Surgery, chemotherapy and/or radiotherapy

Intervention Type: PROCEDURE

Surgery, chemotherapy and/or radiotherapy

Interventions

capecitabine

Capecitabine 1000mg/day for one year

Intervention Type: DRUG

Surgery, chemotherapy and/or radiotherapy

Surgery, chemotherapy and/or radiotherapy

Intervention Type: PROCEDURE

Other Intervention Names

Xeloda

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Cancer Institute (NCI)

NIH

Sponsor Role: collaborator

Barbara Ann Karmanos Cancer Institute

OTHER

Sponsor Role: lead

Responsible Party

George Yoo

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

George H. Yoo, MD

Role: STUDY_CHAIR

Barbara Ann Karmanos Cancer Institute

Locations

Barbara Ann Karmanos Cancer Institute

Detroit, Michigan, United States

Countries

United States

Related Links

http://cancer.gov/clinicaltrials

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

Other Identifiers

P30CA022453

Identifier Type: NIH

Identifier Source: secondary_id

View Link

WSU-D-2688

Identifier Type: OTHER

Identifier Source: secondary_id

WSU-HIC-120103M1F

Identifier Type: OTHER

Identifier Source: secondary_id

2688

Identifier Type: -

Identifier Source: org_study_id