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

AstraZeneca2 sites in 1 country36 target enrollmentJuly 2003

ConditionsHead and Neck Cancer

DrugsZD1839 (IRESSA™)Docetaxel Cisplatin

Overview

Phase: Phase 2
Intervention: Not specified
Conditions: Head and Neck Cancer
Sponsor: AstraZeneca
Enrollment: 36
Locations: 2
Primary Endpoint: Objective tumour response (CR and PR) at study closure based on the Response Evaluation Criteria in Solid Tumours (RECIST)
Status: Completed
Last Updated: 15 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

July 2003

End Date

March 2006

Last Updated

15 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

AstraZeneca

Eligibility Criteria

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

Outcomes

Primary Outcomes

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

Secondary Outcomes

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)