Status:
COMPLETED
ZD1839 (Iressa™) and Concurrent Chemo-Radiation in Patients With Locally Advanced Non Small Cell Lung Cancer
Lead Sponsor:
AstraZeneca
Conditions:
Non Small Cell Lung Carcinoma
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
The primary objective of the trial is to determine the Maximum tolerated dose, if any, of the combination of daily ZD1839 250 mg with carboplatin AUC 2 and 60 Gray (Gy) irradiation and up to 45 mg/m2 ...
Eligibility Criteria
Inclusion
- Patients with histologically or cytologically confirmed locally advanced stage IIIA or IIIB NSCLC (without pleural effusion)
- Patients with apical tumours and supraclavicular nodes are acceptable if both can be easily encompassed in one radiation field
- Minimum life expectancy with treatment of 6 months
- WHO performance status 0-1
Exclusion
- Patients with previous malignancies other than NSCLC
- Previous radiotherapy for NSCLC
- Previous immunotherapy or chemotherapy
- Any unresolved chronic toxicity greater than CTC grade 2 from previous anticancer therapy
- Forced expiratory volume in 1 second (FEV1) less than 1 litre (L)
- Absolute neutrophil count (ANC) less than 1.5 x 109/L or platelets less than 100 x 109/L
- Serum bilirubin greater than 1.25 times the upper limit of reference range
- ALT or AST greater than 2.5 times the ULRR
Key Trial Info
Start Date :
July 1 2002
Trial Type :
INTERVENTIONAL
End Date :
October 1 2005
Estimated Enrollment :
44 Patients enrolled
Trial Details
Trial ID
NCT00252798
Start Date
July 1 2002
End Date
October 1 2005
Last Update
December 19 2007
Active Locations (2)
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1
Research Site
Woolloonabba, Queensland, Australia
2
Research Site
East Melbourne, Victoria, Australia