- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00242762
ZD1839 (IRESSA™) in Combination With Docetaxel & Cisplatin in Subjects With Metastatic Head & Neck Cancer
January 25, 2011 updated by: AstraZeneca
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
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment
36
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Granada, Spain
- Research Facility
-
Madrid, Spain
- Research Facility
-
Murcia, Spain
- Research Facility
-
Sevilla, Spain
- Research Site
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 70 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Male or female, aged 18 and 70 years, inclusive
- Histologically- or cytologically-confirmed recurrent and/or metastatic SCCHN
- Primary tumour site of oral cavity, oropharynx, hypopharynx or larynx
- At least one uni-dimensionally measurable lesion according to the RECIST
- World Health Organisation (WHO) performance status (PS) of 0 or 1
- No previous chemotherapy for recurrent or metastatic disease
- Before subject registration a quality of life questionnaire should be completed
Exclusion Criteria:
- Previous chemotherapy for recurrent or metastatic disease
- Less than 6 months since prior induction or adjuvant platinum and/or taxanes chemotherapy
- Known severe hypersensitivity to ZD1839 or any of the excipients of this product
- Known, severe hypersensitivity to docetaxel or cisplatin or any of the excipients of these products, or to other drugs formulated with polysorbate 80
- Other co-existing malignancies or malignancies diagnosed within the last 5 years with the exception of basal cell carcinoma or cervical cancer in situ
- Any unresolved chronic toxicity greater than common toxicity criteria (CTC) grade 2 from previous anticancer therapy (except alopecia)
- 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
- Serum bilirubin greater than the upper limit of the reference range (ULRR)
- Serum creatinine greater than 1.5 mg/dl despite adequate rehydration
- Creatinine clearance less than 60 ml/min assessed in over a 24 hour urine collection
- As judged by the investigator, any evidence of severe or uncontrolled systemic disease (e.g., unstable or uncompensated respiratory, cardiac, hepatic, or renal disease)
- 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
- Evidence of any other significant clinical disorder or laboratory finding that makes it undesirable for the subject to participate in the study
- Pregnancy or breast feeding (women of child-bearing potential)
- Concomitant use of phenytoin, carbamazepine, rifampicin, or barbiturates, or St John's Wort
- Treatment with a non-approved or investigational drug within 30 days before Day 1 of study treatment
- Any evidence of clinically active interstitial lung disease (patients with chronic stable radiographic changes who are asymptomatic need not be excluded
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
---|
Objective tumour response (CR and PR) at study closure based on the Response Evaluation Criteria in Solid Tumours (RECIST)
|
Secondary Outcome Measures
Outcome Measure |
---|
Overall survival
|
PFS
|
Nature, incidence and severity of adverse events (AEs) and serious adverse events (SAEs)
|
Incidence of DLT during the first cycle of study treatment
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
July 1, 2003
Primary Completion (Actual)
March 1, 2006
Study Completion (Actual)
March 1, 2006
Study Registration Dates
First Submitted
October 20, 2005
First Submitted That Met QC Criteria
October 20, 2005
First Posted (Estimate)
October 21, 2005
Study Record Updates
Last Update Posted (Estimate)
January 27, 2011
Last Update Submitted That Met QC Criteria
January 25, 2011
Last Verified
January 1, 2011
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 1839IL/0504
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Head and Neck Cancer
-
Robert FerrisAmgenCompletedHead and Neck Cancer | Cancer of Head and Neck | Head Cancer | Neck Cancer | Neoplasms, Head and Neck | Cancer of the Head and Neck | Cancer of Neck | Upper Aerodigestive Tract Neoplasms | Neck Neoplasms | Cancer of the Head | Cancer of the Neck | UADT Neoplasms | Cancer of Head | Head Neoplasms | Head, Neck Neoplasms | Neoplasms, Head and other conditionsUnited States
-
Assiut UniversityRecruitingHead and Neck Cancer | Head and Neck Neoplasms | Cancer of Head and Neck | Neoplasms, Head and Neck | Cancer of the Head and NeckEgypt
-
Mayo ClinicRecruitingCancer Head Neck | Cancer Neck | Cancer, HeadUnited States
-
IRCCS Policlinico S. MatteoNestlé Health Science Spain; Akern SrlCompletedHead-neck CancerItaly
-
University of California, San FranciscoCompleted
-
Chinook Therapeutics, Inc. (formerly Aduro)TerminatedRecurrent Head and Neck Cancer | Metastatic Head and Neck CancerUnited States
-
M.D. Anderson Cancer CenterNational Cancer Institute (NCI)TerminatedHead And Neck CancerUnited States
-
National Cancer Institute (NCI)TerminatedRecurrent Head and Neck Cancer | Metastatic Head and Neck CancerUnited States
-
Radboud University Medical CenterUnknown
-
Centre Oscar LambretUnknownEpidermoid Head and Neck CancerFrance
Clinical Trials on Docetaxel
-
Nereus Pharmaceuticals, Inc.CompletedCancerUnited States, Australia, India, Chile, Brazil, Argentina
-
Tianjin Medical University Cancer Institute and...Recruiting
-
Zhuhai Beihai Biotech Co., LtdCompletedSolid Tumours | Bioequivalence | DocetaxelIndia
-
Jiangsu HengRui Medicine Co., Ltd.Shanghai Pulmonary Hospital, Shanghai, ChinaCompletedNon-Small Cell Lung Cancer (NSCLC)China
-
National Cancer Center, KoreaSeoul National University Bundang Hospital; Gachon University Gil Medical Center and other collaboratorsUnknownGastric CancerKorea, Republic of
-
Optimal Health ResearchCompletedBreast Cancer | Lung Cancer | Prostate CancerUnited States
-
Arog Pharmaceuticals, Inc.WithdrawnCarcinoma, Non-Small-Cell Lung
-
Boehringer IngelheimCompletedCarcinoma, Non-Small-Cell LungJapan
-
SanofiCompleted
-
SanofiCompletedLung NeoplasmsFrance, Netherlands, Spain, Turkey, Belgium, Finland, Italy, United Kingdom