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Head and Neck CancerPhase 2NCT00448552

Oxaliplatin and Capecitabine in Treating Patients With Relapsed or Metastatic Head and Neck Cancer

A Phase 2 study testing capecitabine and oxaliplatin in people with Head and Neck Cancer, run by University of Miami at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

RATIONALE: Drugs used in chemotherapy, such as oxaliplatin and capecitabine, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more tumor cells. Read more about this study

Who is it for?
Ages 18 to 120 years
Conditions the study is for
Head and Neck Cancer
What is being tested?
capecitabine and oxaliplatin
How many people
30 participants
Where
1 siteUnited States
Study dates
Feb 2004to Jun 2008
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 to 120 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

DISEASE CHARACTERISTICS:

  • Histologically or cytologically confirmed head and neck cancer
  • Relapsed or metastatic disease
  • Measurable disease
  • No CNS metastases (unless CNS metastases have been stable for > 3 months)
  • No clinically significant pericardial effusion

PATIENT CHARACTERISTICS:

  • ECOG performance status 0-2
  • Life expectancy > 3 months
  • Absolute granulocyte count > 1,500/mm³
  • Platelet count > 100,000/mm³
  • Bilirubin < 2.0 times upper limit of normal (ULN)
  • AST or ALT < 2.5 times ULN
  • Alkaline phosphatase < 2.5 times ULN (5 times ULN if liver metastases are present or 10 times ULN if bone disease is present)
  • Creatinine clearance ≥ 30 mL/min
  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception during and for 30 days after completion of study treatment
  • No clinically serious, uncontrolled cardiovascular disease
  • No New York Heart Association class III-IV heart disease
  • No myocardial infarction within the past 6 months
  • No congestive heart failure
  • No unstable angina
  • No arrhythmia
  • No concurrent serious, uncontrolled infections
  • No other cancer requiring treatment within the past 5 years, except cured nonmelanoma skin cancer or treated in situ cervical cancer
  • No loss of physical integrity of the upper gastrointestinal tract or malabsorption syndrome
  • No history of persistent neurosensory disorder including, but not limited to, peripheral neuropathy
  • No history of uncontrolled seizures or CNS disorders
  • No history of psychiatric disability or other serious uncontrolled medical condition that would preclude study compliance
  • No history of clinically significant interstitial lung disease and/or pulmonary fibrosis
  • No prior hypersensitivity or unanticipated severe reaction to fluoropyrimidine therapy, fluorouracil, or platinum-based compounds

PRIOR CONCURRENT THERAPY:

  • No prior chemotherapy for metastatic or relapsed disease
  • More than 4 weeks since prior major surgery and recovered
  • More than 4 weeks since prior participation in any investigational drug study
  • At least 6 months since prior adjuvant fluoropyrimidine therapy
  • No other prior fluoropyrimidines
  • At least 6 months since prior adjuvant platinum-based therapy
  • No other prior platinum-based therapy
  • No concurrent radiotherapy to the head and neck
  • No other concurrent chemotherapy

Trial locations and contacts

1 site in 1 country.

United States1 site

  • University of Miami Sylvester Comprehensive Cancer Center

    Miami, Florida, 33136

Other trials in United States

About this study

Official title: Treatment of Relapsed or Metastatic Head and Neck Carcinomas With Oxaliplatin and Capecitabine

RATIONALE: Drugs used in chemotherapy, such as oxaliplatin and capecitabine, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more tumor cells.

PURPOSE: This phase II trial is studying how well giving oxaliplatin together with capecitabine works in treating patients with relapsed or metastatic head and neck cancer.

Read the detailed description

OBJECTIVES:

Primary

  • Determine the objective response rate in patients with chemotherapy naïve relapsed or metastatic head and neck cancer treated with oxaliplatin and capecitabine.

Secondary

  • Evaluate the safety and toxicity of this regimen in these patients.
  • Determine the one-year survival and overall survival of these patients.

OUTLINE: Patients receive oxaliplatin IV over 2 hours on day 1 and oral capecitabine twice daily on days 2-15. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed every 3 months for 2 years, every 6 months for 2 years, and then annually thereafter.

PROJECTED ACCRUAL: A total of 30 patients will be accrued for this study.

Keywords
recurrent squamous cell carcinoma of the hypopharynx, stage IV squamous cell carcinoma of the hypopharynx, recurrent squamous cell carcinoma of the larynx, recurrent verrucous carcinoma of the larynx, stage IV squamous cell carcinoma of the larynx, stage IV verrucous carcinoma of the larynx, recurrent squamous cell carcinoma of the lip and oral cavity, stage IV squamous cell carcinoma of the lip and oral cavity, recurrent basal cell carcinoma of the lip, stage IV basal cell carcinoma of the lip, recurrent adenoid cystic carcinoma of the oral cavity, recurrent mucoepidermoid carcinoma of the oral cavity, recurrent verrucous carcinoma of the oral cavity, stage IV adenoid cystic carcinoma of the oral cavity, stage IV mucoepidermoid carcinoma of the oral cavity, stage IV verrucous carcinoma of the oral cavity, recurrent metastatic squamous neck cancer with occult primary, recurrent lymphoepithelioma of the nasopharynx, recurrent squamous cell carcinoma of the nasopharynx, stage IV lymphoepithelioma of the nasopharynx
Medical subject headings
Head and Neck Neoplasms, Squamous Cell Carcinoma of Head and Neck, Esthesioneuroblastoma, Olfactory, Salivary Gland Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Objective response rate (complete response and partial response)

Secondary outcomes (2)

  1. Toxicity as measured by NCI CTC

  2. Survival

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 Mar 2007 (estimated)
  2. Study startFeb 2004
  3. Primary completionApr 2007
  4. Study completionJun 2008

Resources

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
Masking
None (open label)
Enrolment
30 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00448552
Sponsor's protocol ID
20030243
Other IDs
SCCC-2003050, WIRB-20060071
Status last verified
Dec 2016
First submitted
15 Mar 2007
Last updated
15 Dec 2016
Results posted
No
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing capecitabine and oxaliplatin in people with Head and Neck Cancer, run by University of Miami at 1 site in United States.

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: finished, as of the sponsor's last update on 15 Dec 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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.

What does the primary outcome measure?

Objective response rate (complete response and partial response). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00448552.

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 15 Dec 2016.

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