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