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

This study has been completed.
Sponsor:
Information provided by:
AstraZeneca
ClinicalTrials.gov Identifier:
NCT00242762
First received: October 20, 2005
Last updated: January 25, 2011
Last verified: January 2011
History of Changes
  Purpose

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 Intervention Phase
Head and Neck Cancer
 Drug: ZD1839 (IRESSA™)
Drug: Docetaxel
Drug: Cisplatin
 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: 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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by AstraZeneca:

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

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

Estimated Enrollment: 36
Study Start Date: July 2003
Study Completion Date: March 2006
Primary Completion Date: March 2006 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00242762

Locations
Spain
Research Facility
Granada, Spain
Research Facility
Madrid, Spain
Research Facility
Murcia, Spain
Research Site
Sevilla, Spain
Sponsors and Collaborators
AstraZeneca
Investigators
Study Director: AstraZeneca Spain Medical Director, MD AstraZeneca
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00242762     History of Changes
Other Study ID Numbers: 1839IL/0504
Study First Received: October 20, 2005
Last Updated: January 25, 2011
Health Authority: Spain: Spanish Agency of Medicines

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
Neoplasms
Docetaxel
Gefitinib
Cisplatin
Antineoplastic Agents
 Therapeutic Uses
Pharmacologic Actions
Radiation-Sensitizing Agents
Physiological Effects of Drugs
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on May 23, 2013