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Phase I/II Trial of Weekly Docetaxel and Cisplatin for Locoregional Recurrent and/or Metastatic Squamous Cell Carcinoma of the Head and Neck (SCCHN)

Phase 1/Phase 2
18 Years
75 Years
Not Enrolling
Head and Neck Neoplasms

Thank you

Trial Information

Phase I/II Trial of Weekly Docetaxel and Cisplatin for Locoregional Recurrent and/or Metastatic Squamous Cell Carcinoma of the Head and Neck (SCCHN)

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

- 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

Type of Study:


Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

AE SAE collection

Outcome Time Frame:

from the inform consent signed up to the end of the study

Safety Issue:


Principal Investigator

Monique Furlan

Investigator Role:

Study Director

Investigator Affiliation:



Canada: Health Canada

Study ID:




Start Date:

August 2003

Completion Date:

April 2006

Related Keywords:

  • Head and Neck Neoplasms
  • Neoplasms
  • Carcinoma
  • Carcinoma, Squamous Cell
  • Head and Neck Neoplasms