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NCT00233636 Clinical Trial

Iressa and Radiotherapy in the Treatment of the Locally Advanced Inoperable Squamous Cell Carcinoma of the Head and Neck

Head and Neck Cancer Clinical Trial

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

Clinical Trial Details — Status: Withdrawn

Administrative data
NCT number NCT00233636
Other study ID # 1839IL/0070
Secondary ID
Status Withdrawn
Phase Phase 2
First received October 4, 2005
Last updated January 25, 2011
Start date July 2003

Study information
Verified date January 2011
Source AstraZeneca
Contact n/a
Is FDA regulated No
Health authority Italy: The Italian Medicines Agency
Study type Interventional

Clinical Trial Summary

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

Recruitment information / eligibility
Status Withdrawn
Enrollment 28
Est. completion date
Est. primary completion date
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility 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)

Study Design

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Drug:
• Iressa (Gefitinib)

Procedure:
• Radiotherapy

Locations
Country Name City State
Italy Research Site Aviano
Italy Research Site Azienda
Italy Research Site Milano
Italy Research Site Napoli
Italy Research Site Palermo
Italy Research Site Ragusa

Sponsors (1)
Lead Sponsor Collaborator
AstraZeneca

Country where clinical trial is conducted

Italy, 

Outcome
Type Measure Description Time frame Safety issue
Primary Tumour Response Rate, as complete response (CR) and partial response (PR) . Six months after Last Patient In.
Secondary Time to progression, Overall survival, Duration of response. Six months after Last Patient In.
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