Recurrent Squamous Cell Carcinoma of the Lip and Oral CavityPhase 2NCT00095641
S0225 Capecitabine in Treating Patients Who Have Undergone Surgery for Locally Recurrent or Persistent Head and Neck Cancer
A Phase 2 study testing capecitabine, adjuvant therapy and chemotherapy in people with Recurrent Squamous Cell Carcinoma of the Lip and Oral Cavity and Recurrent Squamous Cell Carcinoma of the Paranasal Sinus and Nasal Cavity, run by SWOG Cancer Research Network.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- 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
- What is being tested?
- capecitabine, adjuvant therapy and chemotherapy
- Type of treatment
- Surgery or procedure
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Start not givento not given
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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
About this study
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
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.
Read the 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.
- Conditions
- 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
- Being tested
- capecitabine, adjuvant therapy, chemotherapy
- Medical subject headings
- Squamous Cell Carcinoma of Head and Neck
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
capecitabineDrug
adjuvant therapyProcedure or surgery
chemotherapyProcedure or surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Nov 2004 (estimated)
Why it stopped: no longer studying this disease site
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Recurrent Squamous Cell Carcinoma of the Lip and Oral CavityStudies of the same condition, open and under way.
- More trials run by SWOG Cancer Research NetworkThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- SWOG Cancer Research Network
- Sponsor type
- Research network
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- David Schwartz, MD, Study chair, M.D. Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00095641
- Sponsor's protocol ID
- CDR0000394169
- Other IDs
- S0225, U10CA032102
- Status last verified
- Nov 2013
- First submitted
- 5 Nov 2004
- Last updated
- 8 Nov 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 8 Nov 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00095641
- Acronym / sponsor ID
- CDR0000394169
- Conditions
- 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
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: no longer studying this disease site
- Enrolment
- 0 participants (actual)
- Lead sponsor
- SWOG Cancer Research NetworkResearch network
- Collaborators
- National Cancer Institute (NCI)
- First posted
- 8 Nov 2004 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| capecitabine | Drug | – |
| adjuvant therapy | Procedure or surgery | – |
| chemotherapy | Procedure or surgery | – |
Primary outcome
Not reported in the source record.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Nov 2013.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
David Schwartz, MD study chair
M.D. Anderson Cancer Center
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing capecitabine, adjuvant therapy and chemotherapy in people with Recurrent Squamous Cell Carcinoma of the Lip and Oral Cavity and Recurrent Squamous Cell Carcinoma of the Paranasal Sinus and Nasal Cavity, run by SWOG Cancer Research Network.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 8 Nov 2013. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Nov 2013.