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

December 14, 2016 updated by: University of Miami

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

30

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Florida
      • Miami, Florida, United States, 33136
        • University of Miami Sylvester Comprehensive Cancer Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 120 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Objective response rate (complete response and partial response)

Secondary Outcome Measures

Outcome Measure
Survival
Toxicity as measured by NCI CTC

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Miami

Investigators

  • Study Chair: Luis E. Raez, MD, FACP, University of Miami Sylvester Comprehensive Cancer Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2004

Primary Completion (Actual)

April 1, 2007

Study Completion (Actual)

June 1, 2008

Study Registration Dates

First Submitted

March 15, 2007

First Submitted That Met QC Criteria

March 15, 2007

First Posted (Estimate)

March 19, 2007

Study Record Updates

Last Update Posted (Estimate)

December 15, 2016

Last Update Submitted That Met QC Criteria

December 14, 2016

Last Verified

December 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 20030243
  • SCCC-2003050 (Other Identifier: University of Miami Sylvester Comprehensive Cancer Center)
  • WIRB-20060071 (Other Identifier: Western Institutional Review Board)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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