Clinical Trials/NCT00233636

NCT00233636

Withdrawn

Phase 2

A 2 Part Phase 2 Trial to Evaluate ZD1839 (Iressa™) & Radiotherapy in Patients w/Locally Advanced Inoperable Squamous Cell Carcinoma of the Head & Neck

AstraZeneca1 site in 1 country28 target enrollmentJuly 2003

ConditionsHead and Neck Cancer Carcinoma, Squamous Cell

DrugsIressa (Gefitinib)

Overview

Phase: Phase 2
Intervention: Not specified
Conditions: Head and Neck Cancer
Sponsor: AstraZeneca
Enrollment: 28
Locations: 1
Primary Endpoint: Tumour Response Rate, as complete response (CR) and partial response (PR) . Six months after Last Patient In.
Status: Withdrawn
Last Updated: 15 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

The aim of the study is to determine if Iressa added to radiotherapy is effective and safe in shrinking tumour dimensions.

Registry

clinicaltrials.gov

Start Date

July 2003

End Date

TBD

Last Updated

15 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Eligibility Criteria

Inclusion Criteria

•Histologically Confirmed locally advanced Squamous Cell Carcinoma of Head and neck
•At least one measurable tumour lesion

Exclusion Criteria

•No previous treatment such as chemotherapy, radiotherapy and/or surgery for Carcinoma Head and Neck
•No 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 evidence of severe or uncontrolled systemic disease (e.g. unstable or uncompensated respiratory, cardiac, hepatic or renal disease)

Outcomes

Primary Outcomes

Tumour Response Rate, as complete response (CR) and partial response (PR) . Six months after Last Patient In.

Secondary Outcomes

Time to progression, Overall survival, Duration of response. Six months after Last Patient In.

Study Sites (1)

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