NCT00333294CompletedPhase 2
A Phase II Open-Label Multicentre Study Of The Efficacy Of ZD1839 (IRESSA™) In Combination With Irradiation Followed By Chemotherapy In Patients With Inoperable Stage III Non Small Cell Lung Cancer
Conditions
Drugs
Trial Snapshot
- Phase
- Phase 2
- Status
- Completed
- Sponsor
- AstraZeneca
- Enrollment
- 50
- Locations
- 4
- Primary Endpoint
- To estimate the objective response rate in patients treated with this drug
Study Overview
Brief Summary
The objective of this study is to determine wether the ZD1839 associated with a radiotherapy, before the beginning of chemotherapy is effective in the treatment of your disease and to evaluate the tolerance of these treatments.
Study Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 75 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Signed informed consent.
- •18 to 75 years inclusive.
- •At least one measurable lesions histologically confirmed inoperable stage III NSCLC.
- •WHO performance status of 0 to 2 inclusive.
- •Adequate pulmonary function, pulmonary dose volume histogram less than or equal to 40 %.
- •Life expectancy of at least 6 months.
- •Using secure contraceptives precautions.
Exclusion Criteria
- •Any previous anti cancer therapy for NSCLC.
- •Known severe hypersensitivity to these products
- •Any evidence of clinically active interstitial lung disease
- •Other co-existing malignancies, symptomatic metastases.
- •Abnormal blood test
- •Weight loss of over 15% in the 3 months before the start of the study.
- •Treatment with a non-approved or investigational drug within 30 days before Day 1 of study treatment.
Outcomes
Primary Outcomes
To estimate the objective response rate in patients treated with this drug
Secondary Outcomes
- Determine the safety and toxicity of this drug in these patients
Investigators
Study Sites (4)
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