Status:
COMPLETED
ZD1839 (IRESSA™) in Combination With Docetaxel & Cisplatin in Subjects With Metastatic Head & Neck Cancer
Lead Sponsor:
AstraZeneca
Conditions:
Head and Neck Cancer
Eligibility:
All Genders
18-70 years
Phase:
PHASE2
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 ob...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
July 1 2003
Trial Type :
INTERVENTIONAL
End Date :
March 1 2006
Estimated Enrollment :
36 Patients enrolled
Trial Details
Trial ID
NCT00242762
Start Date
July 1 2003
End Date
March 1 2006
Last Update
January 27 2011
Active Locations (4)
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1
Research Facility
Granada, Spain
2
Research Facility
Madrid, Spain
3
Research Facility
Murcia, Spain
4
Research Site
Seville, Spain