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S0225 Capecitabine in Treating Patients Who Have Undergone Surgery for Locally Recurrent or Persistent Head and Neck Cancer

Primary Purpose

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

Status
Withdrawn
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
capecitabine
adjuvant therapy
chemotherapy
Sponsored by
SWOG Cancer Research Network
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Recurrent Squamous Cell Carcinoma of the Lip and Oral Cavity

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

    Outcomes

    Primary Outcome Measures

    Secondary Outcome Measures

    Full Information

    First Posted
    November 5, 2004
    Last Updated
    November 7, 2013
    Sponsor
    SWOG Cancer Research Network
    Collaborators
    National Cancer Institute (NCI)
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00095641
    Brief Title
    S0225 Capecitabine in Treating Patients Who Have Undergone Surgery for Locally Recurrent or Persistent Head and Neck Cancer
    Official Title
    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
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    November 2013
    Overall Recruitment Status
    Withdrawn
    Why Stopped
    no longer studying this disease site
    Study Start Date
    undefined (undefined)
    Primary Completion Date
    undefined (undefined)
    Study Completion Date
    undefined (undefined)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    SWOG Cancer Research Network
    Collaborators
    National Cancer Institute (NCI)

    4. Oversight

    Data Monitoring Committee
    Yes

    5. Study Description

    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 remaining tumor cells. PURPOSE: This phase II trial is studying how well capecitabine works in treating patients who have undergone surgery for locally recurrent or persistenthead and neck cancer.
    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 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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    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

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 2
    Enrollment
    0 (Actual)

    8. Arms, Groups, and Interventions

    Intervention Type
    Drug
    Intervention Name(s)
    capecitabine
    Intervention Type
    Procedure
    Intervention Name(s)
    adjuvant therapy
    Intervention Type
    Procedure
    Intervention Name(s)
    chemotherapy

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility 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
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    David Schwartz, MD
    Organizational Affiliation
    M.D. Anderson Cancer Center
    Official's Role
    Study Chair

    12. IPD Sharing Statement

    Learn more about this trial

    S0225 Capecitabine in Treating Patients Who Have Undergone Surgery for Locally Recurrent or Persistent Head and Neck Cancer

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