Phase II (Treatment) Study of Oxaliplatin and Capecitabine in Advanced Head and Neck Malignancies

This study has been completed.
Sponsor:
Collaborator:
University of Louisville
Information provided by (Responsible Party):
James Graham Brown Cancer Center
ClinicalTrials.gov Identifier:
NCT00266279
First received: December 15, 2005
Last updated: April 12, 2013
Last verified: April 2013
  Purpose

This phase II study will test the response rate of combined oxaliplatin and capecitabine treatment when administered at a given dose and schedule, in patients with Head and Neck cancer for which there is no curative treatment.


Condition Intervention Phase
Head or Neck Cancer
Drug: Oxaliplatin, Capecitabine
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Phase II Study of Oxaliplatin and Capecitabine in Advanced Head and Neck Malignancies

Resource links provided by NLM:


Further study details as provided by James Graham Brown Cancer Center:

Primary Outcome Measures:
  • Response Rate [ Time Frame: Every two 28 day treatment cycles ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Qualitative and quantitative toxicity [ Time Frame: Every two 28 day treatment cycles ] [ Designated as safety issue: Yes ]

Enrollment: 17
Study Start Date: April 2005
Study Completion Date: October 2009
Primary Completion Date: October 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Treatment with Study Drugs
Treatment with combination of oxaliplatin and capecitabine using study dose and schedule.
Drug: Oxaliplatin, Capecitabine

Agent, DOSE AND SCHEDULE (28-days cycle):

Oxaliplatin 85 mg/m2 IV on days 1 and 15 Capecitabine 1500 mg PO BID on days 1-7 and 15-21

Other Name: Oxaliplatin, Capecitabine

Detailed Description:

The optimal dose and schedule for the combined treatment with oxaliplatin and capecitabine have not been defined. The aim of this Phase II study is to determine the response rate of combined oxaliplatin and capecitabine treatment at a given dose and schedule in patients with Head and Neck cancer for which there is no curative treatment.

The study also aims to determine the qualitative and quantitative toxicity and reversibility of toxicity of the above combination and to evaluate any changes in performance status, quality of life, overall survival and progression-free survival.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients must have histologically or cytologically confirmed squamous cell cancer of Head and Neck
  • Patients must have metastatic or locally recurrent disease
  • Patients must have disease not curable by surgery as estimated by one of the protocol investigators, and should not be eligible for reradiation protocol or have failed reradiation protocol.
  • Patients must have measurable disease, defined as at least one lesion that can be accurately measured in at least one dimension (longest diameter to be recorded) as >20 mm with conventional techniques or as >10 mm with spiral CT scan
  • Age >18 years of age
  • Life expectancy of greater than 12 weeks
  • ECOG performance status 0, 1 or 2 (Karnofsky >50%; see Appendix B)
  • Patients must have adequate bone marrow function as defined below:

    • absolute neutrophil count > 1,500
    • platelets > 100,000
    • hemoglobin > 8 g/dl
  • Patients must have adequate renal function as defined by a creatinine clearance >30 mL/min (measured or estimated by the Cockroft and Gault equation)

    • Cockroft and Gault equation:
    • Creatinine clearance for males =(140-age[yrs])(body wt[kg])/72(serum creatinine[mg/dL])
    • Creatinine clearance for females = 0.85 x male value
  • Patients must have adequate liver function as defined below:

    • total bilirubin 1.5x upper limit of normal
    • albumin > 2.5 g/dl
    • AST(SGOT) and ALT(SGPT) and Alkaline Phosphatase must be < 5 times upper limit of normal
  • Patients could have received 1 or 2 previous chemotherapy regimens prior to entering the study. Patients must have recovered from acute toxicities from chemotherapy or radiotherapy administered prior to entering this study. Alopecia may not be resolved and peripheral neuropathy (grade 1) may be present.
  • Patients with reproductive potential must use an adequate contraceptive method (e.g., abstinence, intrauterine device, oral contraceptives, barrier device with spermicide or surgical sterilization) during treatment and for three months after completing treatment.
  • Ability to understand and willingness to sign a written informed consent document

Exclusion Criteria:

  • Prior unanticipated severe reaction to fluoropyrimidine therapy or known hypersensitivity to 5-fluorouracil or oxaliplatin
  • Patients who have had chemotherapy or radiotherapy within 4 weeks prior to first treatment in this study or those who have not recovered from adverse events due to agents administered more than 4 weeks earlier
  • Patients receiving any other investigational agent(s)
  • Patients with symptomatic brain metastases or actively receiving any therapy for brain metastasis (because of their poor prognosis and because they often develop progressive neurologic dysfunction that would confound the evaluation of neurologic and other adverse events)
  • Active second malignancy in the last 5 years except for non-melanoma skin cancer or carcinoma-in-situ
  • Clinically significant cardiac disease (e.g. congestive heart failure, New York Heart Association Class II or greater, symptomatic coronary artery disease and cardiac arrhythmias) or myocardial infarction within the last 12 months.
  • If patient is unable to swallow, xeloda may be crushed per hospital policy/procedure. See attached Appendix G.
  • Patients who have had an organ allograft.
  • Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, or psychiatric illness/social situations that would limit compliance with study requirements.
  • Pregnancy
  • Known Hepatitis B , Hepatitis C, HIV

Inclusion of Minorities:

Members of all ethnic groups are eligible for this trial.

  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: NCT00266279

Locations
United States, Kentucky
University of Louisville, James Graham Brown Cancer Center
Louisville, Kentucky, United States, 40202
Sponsors and Collaborators
James Graham Brown Cancer Center
University of Louisville
Investigators
Principal Investigator: Damian Laber, M.D. University of Louisville, James Graham Brown Cancer Center
  More Information

Additional Information:
Publications:
Responsible Party: James Graham Brown Cancer Center
ClinicalTrials.gov Identifier: NCT00266279     History of Changes
Other Study ID Numbers: 153.05
Study First Received: December 15, 2005
Last Updated: April 12, 2013
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Capecitabine
Fluorouracil
Oxaliplatin
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Antineoplastic Agents
Therapeutic Uses
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on September 22, 2014