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

AstraZeneca

Status and phase: Completed; Phase 1

Conditions: Non Small Cell Lung Carcinoma

Treatments: Procedure: Radiation; Drug: Carboplatin; Drug: Paclitaxel; Drug: Gefitinib

Study type: Interventional

Funder types: Industry

Identifiers

NCT00252798

D7913C00073

1839IL/0073

Details and patient eligibility

About

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.

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)