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


Phase 2
18 Years
N/A
Not Enrolling
Both
Head and Neck Cancer

Thank you

Trial Information

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


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.

Inclusion Criteria


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

Type of Study:

Interventional

Study Design:

Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Objective response rate (complete response and partial response)

Safety Issue:

No

Principal Investigator

Luis E. Raez, MD, FACP

Investigator Role:

Study Chair

Investigator Affiliation:

University of Miami Sylvester Comprehensive Cancer Center

Authority:

United States: Food and Drug Administration

Study ID:

EPROST-20030243

NCT ID:

NCT00448552

Start Date:

February 2004

Completion Date:

June 2008

Related Keywords:

  • Head and Neck Cancer
  • 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
  • stage IV squamous cell carcinoma of the nasopharynx
  • recurrent lymphoepithelioma of the oropharynx
  • recurrent squamous cell carcinoma of the oropharynx
  • stage IV lymphoepithelioma of the oropharynx
  • stage IV squamous cell carcinoma of the oropharynx
  • recurrent esthesioneuroblastoma of the paranasal sinus and nasal cavity
  • recurrent inverted papilloma of the paranasal sinus and nasal cavity
  • recurrent midline lethal granuloma of the paranasal sinus and nasal cavity
  • recurrent squamous cell carcinoma of the paranasal sinus and nasal cavity
  • stage IV esthesioneuroblastoma of the paranasal sinus and nasal cavity
  • stage IV inverted papilloma of the paranasal sinus and nasal cavity
  • stage IV midline lethal granuloma of the paranasal sinus and nasal cavity
  • stage IV squamous cell carcinoma of the paranasal sinus and nasal cavity
  • recurrent salivary gland cancer
  • stage IV salivary gland cancer
  • untreated metastatic squamous neck cancer with occult primary
  • metastatic squamous neck cancer with occult primary squamous cell carcinoma
  • Head and Neck Neoplasms

Name

Location
University of Miami Sylvester Comprehensive Cancer Center Miami, Florida  33136