ZD1839 (IRESSA™) in Combination With Docetaxel & Cisplatin in Subjects With Metastatic Head & Neck Cancer

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: NCT00242762
Recruitment Status : Completed
First Posted : October 21, 2005
Last Update Posted : January 27, 2011
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Brief Summary:
The primary objective of the study is to evaluate the activity of the combination ZD1839, docetaxel and cisplatin in subjects with recurrent and/or metastatic head and neck cancer by estimating the objective response rate (complete response [CR] and partial response [PR]) at study closure.

Condition or disease Intervention/treatment Phase
Head and Neck Cancer Drug: ZD1839 (IRESSA™) Drug: Docetaxel Drug: Cisplatin Phase 2

Study Type : Interventional  (Clinical Trial)
Enrollment : 36 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase II Study to Evaluate the Safety and Efficacy of the Combination of ZD1839 (IRESSA™), Docetaxel and Cisplatin in Subjects With Recurrent and/or Metastatic Head and Neck Cancer
Study Start Date : July 2003
Actual Primary Completion Date : March 2006
Actual Study Completion Date : March 2006

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Primary Outcome Measures :
  1. Objective tumour response (CR and PR) at study closure based on the Response Evaluation Criteria in Solid Tumours (RECIST)

Secondary Outcome Measures :
  1. PFS
  2. Overall survival
  3. Incidence of DLT during the first cycle of study treatment
  4. Nature, incidence and severity of adverse events (AEs) and serious adverse events (SAEs)

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  1. Male or female, aged 18 and 70 years, inclusive
  2. Histologically- or cytologically-confirmed recurrent and/or metastatic SCCHN
  3. Primary tumour site of oral cavity, oropharynx, hypopharynx or larynx
  4. At least one uni-dimensionally measurable lesion according to the RECIST
  5. World Health Organisation (WHO) performance status (PS) of 0 or 1
  6. No previous chemotherapy for recurrent or metastatic disease
  7. Before subject registration a quality of life questionnaire should be completed

Exclusion Criteria:

  1. Previous chemotherapy for recurrent or metastatic disease
  2. Less than 6 months since prior induction or adjuvant platinum and/or taxanes chemotherapy
  3. Known severe hypersensitivity to ZD1839 or any of the excipients of this product
  4. Known, severe hypersensitivity to docetaxel or cisplatin or any of the excipients of these products, or to other drugs formulated with polysorbate 80
  5. Other co-existing malignancies or malignancies diagnosed within the last 5 years with the exception of basal cell carcinoma or cervical cancer in situ
  6. Any unresolved chronic toxicity greater than common toxicity criteria (CTC) grade 2 from previous anticancer therapy (except alopecia)
  7. Absolute neutrophil count (ANC) less than 1.5 x109/litre (L), platelets less than 100 x 109/L or haemoglobin less than 10 g/dl
  8. Serum bilirubin greater than the upper limit of the reference range (ULRR)
  9. Serum creatinine greater than 1.5 mg/dl despite adequate rehydration
  10. Creatinine clearance less than 60 ml/min assessed in over a 24 hour urine collection
  11. As judged by the investigator, any evidence of severe or uncontrolled systemic disease (e.g., unstable or uncompensated respiratory, cardiac, hepatic, or renal disease)
  12. Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) greater than 1.5 times the ULRR or alkaline phosphatase (ALP) greater than 2.5 times the ULRR
  13. Evidence of any other significant clinical disorder or laboratory finding that makes it undesirable for the subject to participate in the study
  14. Pregnancy or breast feeding (women of child-bearing potential)
  15. Concomitant use of phenytoin, carbamazepine, rifampicin, or barbiturates, or St John's Wort
  16. Treatment with a non-approved or investigational drug within 30 days before Day 1 of study treatment
  17. Any evidence of clinically active interstitial lung disease (patients with chronic stable radiographic changes who are asymptomatic need not be excluded

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): NCT00242762

Research Facility
Granada, Spain
Research Facility
Madrid, Spain
Research Facility
Murcia, Spain
Research Site
Sevilla, Spain
Sponsors and Collaborators
Study Director: AstraZeneca Spain Medical Director, MD AstraZeneca Identifier: NCT00242762     History of Changes
Other Study ID Numbers: 1839IL/0504
First Posted: October 21, 2005    Key Record Dates
Last Update Posted: January 27, 2011
Last Verified: January 2011

Keywords provided by AstraZeneca:
Head and Neck Neoplasms
Cancer of Head and Neck
Head and Neck Cancer
Head Cancer
Neck Cancer

Additional relevant MeSH terms:
Head and Neck Neoplasms
Neoplasms by Site
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Protein Kinase Inhibitors
Enzyme Inhibitors