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Docetaxel in Squamous Cell Carcinoma of the Head and Neck (TAX + Cisplatin in SCCHN)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00268671
Recruitment Status : Completed
First Posted : December 22, 2005
Last Update Posted : December 7, 2009
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Brief Summary:

Study Objectives:

  • To determine the MTD (maximal tolerated dose) and recommended dose of a weekly docetaxel and cisplatin combination regimen for locoregional recurrent/metastatic Squamous Cell Carcinoma of the Head and Neck (SCCHN)
  • To determine the response rate of the recommended dose
  • To determine the safety and tolerability of the recommended dose

Condition or disease Intervention/treatment Phase
Head and Neck Neoplasms Drug: Docetaxel Phase 1 Phase 2

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Study Type : Interventional  (Clinical Trial)
Enrollment : 45 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase I/II Trial of Weekly Docetaxel and Cisplatin for Locoregional Recurrent and/or Metastatic Squamous Cell Carcinoma of the Head and Neck (SCCHN)
Study Start Date : August 2003
Actual Primary Completion Date : April 2006
Study Completion Date : April 2006

Resource links provided by the National Library of Medicine

Primary Outcome Measures :
  1. AE SAE collection [ Time Frame: from the inform consent signed up to the end of the study ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Histologically confirmed (of original primary tumor) locoregional recurrent and/or metastatic following prior radiotherapy and/or surgery and not amenable to further curative local therapy for SCCHN
  • Measurable disease as defined by at least the longest diameter measured as 20 mm by conventional CT or 10 mm by spiral CT. Physical measurements are allowed if longest diameter is 20 mm by caliper measurements.
  • ECOG performance status 0-2
  • Adequate bone marrow and hepatic function as evidenced by the following:

    • Hematology (Bone marrow):

      • Neutrophils ≥ 1.50 x 10^9/L
      • Platelets ≥ 100 x 10^9/L
      • Hemoglobin ≥ 10 g/dL
    • Hepatic function:

      • AST and/or ALT: < 2X ULN (Upper Limit of Normal)
      • Bilirubin < 1X ULN
  • Adequate renal function with calculated or measured glomerular filtration rate of > 60 ml/min calculated by the Cockcroft- Gault method
  • No severe intercurrent illness or other serious illness or medical conditions including but not limited to:

    • Unstable cardiac disease despite treatment, myocardial infarction within 6 months prior to study entry.
    • Active uncontrolled infection
    • Active peptic ulcer
    • Chronic obstructive pulmonary disease requiring hospitalization during the year preceding study entry
  • No prior chemotherapy for recurrent/advanced SCCHN with platinum or taxane regimen (primary radiosensitizing platinum allowed).
  • No other diagnosed malignancy other than basal cell carcinoma of the skin or cervix carcinoma in situ

Exclusion Criteria:

  • Prior therapy with taxanes either adjuvant, neoadjuvant, concurrent or in advanced stage disease
  • Prior chemotherapy for locoregional recurrent/metastatic SCCHN with palliative intent
  • Contraindications from

    • the medical history (i.e. known hepatitis, HIV) and physical exam
    • laboratory tests (hematology, biochemistry)
    • 12-lead electrocardiogram
    • blood pressure and pulse
  • Pregnancy
  • Breast-feeding
  • Treatment with any investigational product in the last 4 weeks before study entry
  • Likelihood of requiring treatment during the study period with drugs not permitted by the clinical study protocol
  • Presence or sequelae of gastrointestinal, liver or kidney disease, or other conditions known to interfere with the absorption, distribution, metabolism, or excretion of drugs
  • History of hypersensitivity to the study drug(s) or to drugs with a similar chemical structure
  • Impaired hepatic function, as shown by bilirubin greater than upper limits of normal and/or AST greater than 2 times upper limits of normal
  • Impaired renal function, as shown by measured or calculated creatinine clearance of < 60 ml/min or absolute creatinine level > 1.5 upper limit of normal

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00268671

Sponsors and Collaborators
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Study Director: Monique Furlan Sanofi

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Responsible Party: Medical Affairs Study Director, sanofi-aventis Identifier: NCT00268671     History of Changes
Other Study ID Numbers: XRP6976G_2501
First Posted: December 22, 2005    Key Record Dates
Last Update Posted: December 7, 2009
Last Verified: December 2009

Additional relevant MeSH terms:
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Carcinoma, Squamous Cell
Squamous Cell Carcinoma of Head and Neck
Head and Neck Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms, Squamous Cell
Neoplasms by Site
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action