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A Phase I Trial to Evaluate ZD1839(Iressa™) and Concurrent Chemo-Radiation in Patients With Locally Advanced Non Small Cell Lung Cancer


Phase 1
18 Years
N/A
Not Enrolling
Both
Non Small Cell Lung Carcinoma

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Trial Information

A Phase I Trial to Evaluate ZD1839(Iressa™) and Concurrent Chemo-Radiation in Patients With Locally Advanced Non Small Cell Lung Cancer


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

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

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.

Principal Investigator

AstraZeneca Australia Medical Director, MD

Investigator Role:

Study Director

Investigator Affiliation:

AstraZeneca

Authority:

Australia: Department of Health and Ageing Therapeutic Goods Administration

Study ID:

D7913C00073

NCT ID:

NCT00252798

Start Date:

July 2002

Completion Date:

October 2005

Related Keywords:

  • Non Small Cell Lung Carcinoma
  • Non Small Cell Lung Cancer
  • Carcinoma
  • Carcinoma, Non-Small-Cell Lung
  • Lung Neoplasms

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