Capecitabine in Treating Patients Who Have Undergone Surgery for Locally Recurrent or Persistent Head and Neck Cancer
This study has been withdrawn prior to enrollment.
(no longer studying this disease site)
Sponsor:
Southwest Oncology Group
Collaborator:
Information provided by (Responsible Party):
Southwest Oncology Group
ClinicalTrials.gov Identifier:
NCT00095641
First received: November 5, 2004
Last updated: November 15, 2012
Last verified: November 2012
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
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 |
Drug: capecitabine Procedure: adjuvant therapy Procedure: chemotherapy |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Primary Purpose: Treatment |
| 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 |
Resource links provided by NLM:
Further study details as provided by Southwest Oncology Group:
| Enrollment: | 0 |
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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations More Information
No publications provided
| Responsible Party: | Southwest Oncology Group |
| ClinicalTrials.gov Identifier: | NCT00095641 History of Changes |
| Other Study ID Numbers: | CDR0000394169, S0225, U10CA032102 |
| Study First Received: | November 5, 2004 |
| Last Updated: | November 15, 2012 |
| Health Authority: | United States: Federal Government |
Additional relevant MeSH terms:
|
Carcinoma Carcinoma, Squamous Cell Head and Neck Neoplasms Hypopharyngeal Neoplasms Laryngeal Neoplasms Paranasal Sinus Neoplasms Oropharyngeal Neoplasms Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type Neoplasms Neoplasms, Squamous Cell Neoplasms by Site Pharyngeal Neoplasms Otorhinolaryngologic Neoplasms Pharyngeal Diseases |
Stomatognathic Diseases Otorhinolaryngologic Diseases Laryngeal Diseases Respiratory Tract Diseases Respiratory Tract Neoplasms Nose Neoplasms Nose Diseases Paranasal Sinus Diseases Adjuvants, Immunologic Capecitabine Fluorouracil Immunologic Factors Physiological Effects of Drugs Pharmacologic Actions Antimetabolites, Antineoplastic |
ClinicalTrials.gov processed this record on June 18, 2013