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S0225: Phase II Study of Adjuvant Low-Dose Capecitabine After Salvage Surgery in Patients With Locally Recurrent or Persistent Squamous Cell Carcinoma of the Head and Neck


Phase 2
18 Years
N/A
Not Enrolling
Both
Recurrent Squamous Cell Carcinoma of the Lip and Oral Cavity, Recurrent Squamous Cell Carcinoma of the Paranasal Sinus and Nasal Cavity, Recurrent Squamous Cell Carcinoma of the Hypopharynx, Recurrent Squamous Cell Carcinoma of the Larynx, Recurrent Squamous Cell Carcinoma of the Oropharynx

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Trial Information

S0225: Phase II Study of Adjuvant Low-Dose Capecitabine After Salvage Surgery in Patients With Locally Recurrent or Persistent Squamous Cell Carcinoma of the Head and Neck


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 of the head and neck .

- Determine the toxic effects of this drug in these patients.

- Determine 2-year overall survival of patients treated with this drug.

- Determine patterns of disease relapse in patients treated with this drug.

OUTLINE: This is a multicenter study.

Patients receive oral capecitabine once daily for 12 months in the absence of disease
progression or unacceptable toxicity.

After completion of study treatment, patients are followed periodically.

PROJECTED ACCRUAL: A total of 70 patients will be accrued for this study within 2 years.

Inclusion Criteria


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

Type of Study:

Interventional

Study Design:

Primary Purpose: Treatment

Principal Investigator

David Schwartz, MD

Investigator Role:

Study Chair

Investigator Affiliation:

M.D. Anderson Cancer Center

Authority:

United States: Federal Government

Study ID:

CDR0000394169

NCT ID:

NCT00095641

Start Date:

Completion Date:

Related Keywords:

  • Recurrent Squamous Cell Carcinoma of the Lip and Oral Cavity
  • Recurrent Squamous Cell Carcinoma of the Paranasal Sinus and Nasal Cavity
  • Recurrent Squamous Cell Carcinoma of the Hypopharynx
  • Recurrent Squamous Cell Carcinoma of the Larynx
  • Recurrent Squamous Cell Carcinoma of the Oropharynx
  • Carcinoma
  • Carcinoma, Squamous Cell
  • Head and Neck Neoplasms
  • Hypopharyngeal Neoplasms
  • Laryngeal Neoplasms
  • Paranasal Sinus Neoplasms
  • Oropharyngeal Neoplasms

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