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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
University of Miami Sylvester Comprehensive Cancer Center
ClinicalTrials.gov Identifier:
NCT00448552
First received: March 15, 2007
Last updated: July 25, 2014
Last verified: August 2013
  Purpose

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.


Condition Intervention Phase
Head and Neck Cancer
Drug: capecitabine
Drug: oxaliplatin
Phase 2

Study Type: Interventional
Study Design: Masking: Open Label
Primary Purpose: Treatment
Official Title: Treatment of Relapsed or Metastatic Head and Neck Carcinomas With Oxaliplatin and Capecitabine

Resource links provided by NLM:


Further study details as provided by University of Miami Sylvester Comprehensive Cancer Center:

Primary Outcome Measures:
  • Objective response rate (complete response and partial response) [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Toxicity as measured by NCI CTC [ Designated as safety issue: Yes ]
  • Survival [ Designated as safety issue: No ]

Estimated Enrollment: 30
Study Start Date: February 2004
Study Completion Date: June 2008
Primary Completion Date: April 2007 (Final data collection date for primary outcome measure)
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00448552

Locations
United States, Florida
University of Miami Sylvester Comprehensive Cancer Center
Miami, Florida, United States, 33136
Sponsors and Collaborators
University of Miami Sylvester Comprehensive Cancer Center
Investigators
Study Chair: Luis E. Raez, MD, FACP University of Miami Sylvester Comprehensive Cancer Center
  More Information

Additional Information:
No publications provided

Responsible Party: University of Miami Sylvester Comprehensive Cancer Center
ClinicalTrials.gov Identifier: NCT00448552     History of Changes
Other Study ID Numbers: UMIAMI-20030243, SCCC-2003050, WIRB-20060071
Study First Received: March 15, 2007
Last Updated: July 25, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by University of Miami Sylvester Comprehensive Cancer Center:
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

Additional relevant MeSH terms:
Head and Neck Neoplasms
Neoplasms by Site
Neoplasms
Capecitabine
Oxaliplatin
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Antineoplastic Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on September 16, 2014