Capecitabine in Treating Patients Who Have Undergone Previous Surgery, Radiation Therapy, and/or Chemotherapy for Head and Neck Cancer - Full Text View

Sponsored by:	Barbara Ann Karmanos Cancer Institute
Information provided by:	National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:	NCT00258310

Purpose

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.

Condition	Intervention	Phase
Head and Neck Cancer	Drug: capecitabine Procedure: adjuvant therapy	Phase II

MedlinePlus related topics: Cancer Head and Neck Cancer

Drug Information available for: Capecitabine

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Open Label
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 After Surgery, Radiation and/or Chemotherapy

Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:

Feasibility of treatment as assessed within 365 days [ Designated as safety issue: No ]

Secondary Outcome Measures:

Time to recurrence as assessed from time of study entry until documented recurrence [ Designated as safety issue: No ]
Local-regional control rate occurrence [ Designated as safety issue: No ]
Survival rate from time of study entry until death [ Designated as safety issue: No ]
Incidence of second primary tumor occurrence [ Designated as safety issue: No ]

Estimated Enrollment:	41
Study Start Date:	December 2003

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

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00258310

Locations

United States, Michigan
Barbara Ann Karmanos Cancer Institute
Detroit, Michigan, United States, 48201-1379

Sponsors and Collaborators

Barbara Ann Karmanos Cancer Institute

Investigators

Study Chair:

George H. Yoo, MD

Barbara Ann Karmanos Cancer Institute

More Information

Clinical trial summary from the National Cancer Institute's PDQ® database This link exits the ClinicalTrials.gov site

Study ID Numbers:	CDR0000445467, WSU-D-2688, WSU-HIC-120103M1F
Study First Received:	November 22, 2005
Last Updated:	August 26, 2008
ClinicalTrials.gov Identifier:	NCT00258310
Health Authority:	United States: Federal Government

Keywords provided by National Cancer Institute (NCI):

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

Study placed in the following topic categories:

Capecitabine
Squamous cell carcinoma
Dental Caries
Carcinoma
Epidermoid carcinoma
Nasopharyngeal carcinoma
Head and Neck Neoplasms

Carcinoma, squamous cell
Laryngeal carcinoma
Hypopharyngeal cancer
Neoplasms, Squamous Cell
Carcinoma, Squamous Cell
Neoplasms, Glandular and Epithelial

Additional relevant MeSH terms:

Antimetabolites
Neoplasms
Antimetabolites, Antineoplastic
Neoplasms by Site
Neoplasms by Histologic Type

Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 14, 2009