Status:
WITHDRAWN
S0225 Capecitabine in Treating Patients Who Have Undergone Surgery for Locally Recurrent or Persistent Head and Neck Cancer
Lead Sponsor:
SWOG Cancer Research Network
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Recurrent Squamous Cell Carcinoma of the Lip and Oral Cavity
Recurrent Squamous Cell Carcinoma of the Paranasal Sinus and Nasal Cavity
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
RATIONALE: Drugs used in chemotherapy, such as capecitabine, work in different ways to stop tumor cells from dividing so they stop growing or die. Giving capecitabine after surgery may kill any remain...
Detailed Description
OBJECTIVES: * Determine 2-year disease-free survival of patients treated with surgical salvage followed by adjuvant low-dose capecitabine for locally recurrent or persistent squamous cell carcinoma o...
Eligibility Criteria
Inclusion
- DISEASE CHARACTERISTICS:
- Histologically confirmed squamous cell carcinoma of the head and neck
- Locoregionally recurrent or persistent disease
- No thyroid gland, salivary gland, or nasopharynx disease sites
- Must have undergone definitive or post-operative radiotherapy at the time of initial curative treatment
- Must have undergone salvage surgical resection within the past 56 days
- All current disease must be completely resected, including resection of recurrent primary disease and/or neck dissection, if regional nodal disease is present
- Surgical margins must be free of disease on final pathological evaluation of specimens
- No definitive or adjuvant radiotherapy or reirradiation for recurrent or persistent disease allowed at the time of salvage treatment
- No evidence of distant disease by clinical examination and CT scan of the chest and upper abdomen (including the liver) within the past 90 days
- PATIENT CHARACTERISTICS:
- Age
- 18 and over
- Performance status
- Zubrod 0-1
- Life expectancy
- Not specified
- Hematopoietic
- Absolute neutrophil count ≥ 1,500/mm\^3
- Platelet count ≥ 100,000/mm\^3
- Hepatic
- Not specified
- Renal
- Creatinine clearance ≥ 30 mL/min
- Other
- Not pregnant or nursing
- Fertile patients must use effective contraception
- Able to take oral tablets OR able to take crushed tablets through a gastrostomy tube
- No other malignancy within the past 5 years except adequately treated basal cell or squamous cell skin cancer or carcinoma in situ of the cervix
- PRIOR CONCURRENT THERAPY:
- Biologic therapy
- No concurrent biologic therapy
- No concurrent filgrastim (G-CSF)
- Chemotherapy
- Prior systemic chemotherapy as definitive therapy for head and neck cancer allowed (prior treatment with fluorouracil allowed, but must be catalogued)
- More than 5 years since prior systemic chemotherapy for any other cancer diagnosis
- No other concurrent chemotherapy
- Endocrine therapy
- No concurrent anticancer hormonal therapy
- Concurrent hormonal therapy for non-cancer diagnosis allowed
- Radiotherapy
- See Disease Characteristics
- No concurrent radiotherapy
- Surgery
- See Disease Characteristics
- Recovered from prior surgery
Exclusion
Key Trial Info
Start Date :
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT00095641
Last Update
November 8 2013
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