Status:
COMPLETED
Ph II Long Term/Low Dose Xeloda in Head and Neck Squamous Cell Carcinoma After Surgery, Radiation & or Chemo
Lead Sponsor:
Barbara Ann Karmanos Cancer Institute
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Head and Neck Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE2
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 capecitabin...
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, radiotherap...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
December 1 2003
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2011
Estimated Enrollment :
35 Patients enrolled
Trial Details
Trial ID
NCT00258310
Start Date
December 1 2003
End Date
February 1 2011
Last Update
March 10 2023
Active Locations (1)
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1
Barbara Ann Karmanos Cancer Institute
Detroit, Michigan, United States, 48201-1379