Phase 2
Completed N=35
Ph II Long Term/Low Dose Xeloda in Head and Neck Squamous Cell Carcinoma After Surgery, Radiation & or Chemo
Source: ClinicalTrials.gov NCT00258310 ↗Enrolled (actual)
35
Serious AEs
5.7%
Results posted
Jan 2015
Primary outcomePrimary: Compliance With Treatment . — 74 percentage of participants
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Compliance With Treatment . |
74 | — |
| SECONDARY Recurrence-free Survival |
NA | — |
| SECONDARY Overall Survival |
NA | — |
| SECONDARY Incidence of Second Primary Tumors |
3 | — |
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
Data sourced from ClinicalTrials.gov (NCT00258310). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.