Overview

ZD1839 (Iressa™) and Concurrent Chemo-Radiation in Patients With Locally Advanced Non Small Cell Lung Cancer

Status:
Completed
Trial end date:
2005-10-01
Target enrollment:
0
Participant gender:
All
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 paclitaxel.
Phase:
Phase 1
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
AstraZeneca
Treatments:
Carboplatin
Gefitinib
Paclitaxel
Criteria
Inclusion Criteria:

- 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 Criteria:

- 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