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Combination of Taxotere and Oxaliplatin in Squamous Cell Carcinoma of the Head and Neck
This study has been suspended.
Sponsors and Collaborators: Norris Comprehensive Cancer Center
Sanofi-Synthelabo
Information provided by: Norris Comprehensive Cancer Center
ClinicalTrials.gov Identifier: NCT00184028
  Purpose

This research study is for subjects with squamous cell cancer of the head and neck which is not solely treatable with surgery or radiation. This research study involves treatment with an experimental chemotherapy combination of oxaliplatin and Taxotere. Tha main purpose of this study is to assess the effectiveness of this combination of medications for this type of cancer.

Approximately 54 subjects will take part in this study.


Condition Intervention Phase
Carcinoma of the Head and Neck
Drug: Taxotere and Oxaliplatin
Phase II

MedlinePlus related topics: Cancer
Drug Information available for: Docetaxel Oxaliplatin
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Non-Randomized, Open Label, Active Control, Single Group Assignment
Official Title: Phase II Trial of Taxotere and Oxaliplatin Combination Chemotherapy in Squamous Cell Carcinoma of the Head and Neck

Further study details as provided by Norris Comprehensive Cancer Center:

Study Start Date: September 2004
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Criteria

Inclusion Criteria:

  • Patients must have histologically or cytologically confirmed Head and Neck Squamous Cell Carcinoma which is metastatic or unresectable and for which standard curative or palliative measures do not exist or are no longer effective.
  • Tissue from tumor must be available. This may be paraffin embedded tissue from previous biopsy/resection. If it is not available, a repeat biopsy must be performed.
  • Age greater than or equal to 18 years
  • ECOG performance status less than or equal to 2 (Karnofsky greater than or equal to 50%)
  • Patients must have adequate organ and marrow function as defined below:
  • leukocytes greater than or equal to 3,000/microliter
  • hemoglobin greater than or equal to 8.0 g/dl
  • absolute neutrophil count greater than or equal to 1,500/microliter
  • platelets greater than or equal to 100,000/microliter
  • total bilirubin within normal institutional limits
  • creatinine within normal institutional limits OR creatinine clearance greater than or equal to 60 mL/min/1.73 m2 for patients with creatinine levels above institutional normal
  • If:

    • ALK PHOS is less than or equal to ULN and AST or ALT is less than or equal to ULN, patient is eligible.
    • ALK PHOS is less than or equal to ULN and AST or ALT is greater than 1x but less than or equal to 1.5x, patient is eligible.
    • ALK PHOS is less than or equal to ULN and AST or ALT is greater than 1.5x but less than or equal to 5x, patient is eligible.
    • ALK PHOS is less than or equal to ULN and AST or ALT is greater than 5x ULN, patient is ineligible.
    • ALK PHOS is greater than 1x but less than or equal to 2.5x and AST or ALT is less than or equal to ULN, patient is eligible.
    • ALK PHOS is greater than 1x but less than or equal to 2.5x and AST or ALT is greater than 1x but less than or equal to 1.5x, patient is eligible.
    • ALK PHOS is greater than 1x but less than or equal to 2.5x and AST or ALT is greater than 1.5x but less than or equal to 5x, patient is ineligible.
    • ALK PHOS is greater than 1x but less than or equal to 2.5x and AST or ALT is greater than 5x ULN, patient is ineligible.
    • ALK PHOS is greater than 2.5x but less than or equal to 5x and ALT or AST is less than or equal to ULN,patient is eligible.
    • ALK PHOS is greater than 2.5x but less than or equal to 5x and ALT or AST is greater than 1x but less than or equal to 1.5x, patient is ineligible.
    • ALK PHOS is greater than 2.5x but less than or equal to 5x and ALT or AST is greater than 1.5x but less than or equal to 5x, patient is ineligible.
    • ALK PHOS is greater than 2.5x but less than or equal to 5x and ALT or AST is greater than 5x ULN, patient is ineligible.
    • ALK PHOS is greater than 5x ULN and AST or ALT is less than or equal to ULN, patient is ineligible.
    • ALK PHOS is greater than 5x ULN and AST or ALT is greter than 1x but less than or equal to 1.5x, patient is ineligible
    • ALK PHOS is greater than 5x ULN and AST or ALT is greater than 1.5x but less than or equal to 5x, patient is ineligible
    • ALK PHOS is greater than 5x ULN and AST or ALT is greater than 5x ULN, patient is ineligible
  • Patients with neuropathy < 1.
  • Ability to understand and the willingness to sign a written informed consent document
  • Women of childbearing potential must have a negative pregnancy test
  • Men and women of childbearing potential must be willing to consent to using effective contraception while on treatment and for at least 3 months thereafter

Exclusion Criteria:

  • Patients who have had chemotherapy or radiotherapy within 4 weeks prior to entering the study
  • Patients undergoing therapy with other investigational agents.
  • Previous treatment involving regimen utilizing any of the protocol chemotherapeutic agents
  • Patients with known brain metastases
  • History of allergy to platinum compounds or to antiemetics appropriate for administration in conjunction with protocol-directed chemotherapy. Patients with a history of severe hypersensitivity reaction to Taxotere or Oxaliplatin or other drugs formulated with polysorbate 80
  • Uncontrolled intercurrent illness including, but not limited to ongoing or active infection, symptomatic congestive heart failure, or unstable angina pectoris, or cardiac arrhythmia
  • Pregnant and nursing women
  • HIV-positive patients
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00184028

Locations
United States, California
USC/Norris Comprehensive Cancer Center
Los Angeles, California, United States, 90033
Sponsors and Collaborators
Norris Comprehensive Cancer Center
Sanofi-Synthelabo
Investigators
Principal Investigator: Barbara Gitlitz, MD University of Southern California
  More Information

Study ID Numbers: 7H-03-1
Study First Received: September 12, 2005
Last Updated: September 12, 2005
ClinicalTrials.gov Identifier: NCT00184028  
Health Authority: United States: Institutional Review Board

Study placed in the following topic categories:
Docetaxel
Epidermoid carcinoma
Oxaliplatin
Squamous cell carcinoma
Carcinoma, squamous cell
Neoplasms, Squamous Cell
Carcinoma, Squamous Cell
Carcinoma, squamous cell of head and neck
Neoplasms, Glandular and Epithelial
Carcinoma

Additional relevant MeSH terms:
Neoplasms
Neoplasms by Histologic Type
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 14, 2009