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

This study has been completed.
Sponsor:
Information provided by:
Sanofi
ClinicalTrials.gov Identifier:
NCT00268671
First received: December 21, 2005
Last updated: December 4, 2009
Last verified: December 2009
  Purpose

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 Intervention Phase
Head and Neck Neoplasms
Drug: Docetaxel
Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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)

Resource links provided by NLM:


Further study details as provided by Sanofi:

Primary Outcome Measures:
  • AE SAE collection [ Time Frame: from the inform consent signed up to the end of the study ] [ Designated as safety issue: No ]

Estimated Enrollment: 45
Study Start Date: August 2003
Estimated Study Completion Date: April 2006
Primary Completion Date: April 2006 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  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: NCT00268671

Sponsors and Collaborators
Sanofi
Investigators
Study Director: Monique Furlan Sanofi
  More Information

No publications provided

Responsible Party: Medical Affairs Study Director, sanofi-aventis
ClinicalTrials.gov Identifier: NCT00268671     History of Changes
Other Study ID Numbers: XRP6976G_2501
Study First Received: December 21, 2005
Last Updated: December 4, 2009
Health Authority: Canada: Health Canada

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

ClinicalTrials.gov processed this record on October 23, 2014