NCT00233636WithdrawnPhase 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
Conditions
Drugs
Trial Snapshot
- Phase
- Phase 2
- Status
- Withdrawn
- Sponsor
- AstraZeneca
- Enrollment
- 28
- Locations
- 6
- Primary Endpoint
- Tumour Response Rate, as complete response (CR) and partial response (PR) . Six months after Last Patient In.
Study Overview
Brief Summary
The aim of the study is to determine if Iressa added to radiotherapy is effective and safe in shrinking tumour dimensions.
Study Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
Investigators
Study Sites (6)
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