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

This study has been completed.
Sponsor:
Information provided by:
AstraZeneca
ClinicalTrials.gov Identifier:
NCT00252798
First received: November 1, 2005
Last updated: December 16, 2007
Last verified: December 2007
History of Changes
  Purpose

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.


Condition Intervention Phase
Non Small Cell Lung Carcinoma
 Drug: Gefitinib
Drug: Carboplatin
Drug: Paclitaxel
Procedure: Radiation
 Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase I Trial to Evaluate ZD1839(Iressa™) and Concurrent Chemo-Radiation in Patients With Locally Advanced Non Small Cell Lung Cancer

Resource links provided by NLM:

MedlinePlus related topics: Cancer Lung Cancer
U.S. FDA Resources

Further study details as provided by AstraZeneca:

Primary Outcome Measures:
  • 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.

Secondary Outcome Measures:
  • To evaluate the activity potential of the combination of ZD1839, carboplatin, paclitaxel & radiation therapy
  • Estimating the objective response rate (complete response [CR] & partial response [PR]) as assessed by positron emission tomography with (18F)-labelled fluorodeoxyglucose (PET-FDG)
  • To estimate the objective response rate (CR and PR) as assessed by computerised tomography (CT) scan
  • To estimate the complete response rate (CR) as assessed by PET-FDG
  • To estimate progression free survival (PFS) as assessed by clinical examination, chest x-ray, CT scan ± PET-FDG
  • To estimate overall survival
  • To characterise the safety and tolerability of ZD1839 combined with concurrent carboplatin, paclitaxel and radiation
  • To determine the site of first failure (characterised as local-regional, distant or both)

Estimated Enrollment: 44
Study Start Date: July 2002
Study Completion Date: October 2005
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00252798

Locations
Australia, Queensland
Research Site
Woolloonabba, Queensland, Australia
Australia, Victoria
Research Site
East Melbourne, Victoria, Australia
Sponsors and Collaborators
AstraZeneca
Investigators
Study Director: AstraZeneca Australia Medical Director, MD AstraZeneca
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00252798     History of Changes
Other Study ID Numbers: D7913C00073, 1839IL/0073
Study First Received: November 1, 2005
Last Updated: December 16, 2007
Health Authority: Australia: Department of Health and Ageing Therapeutic Goods Administration

Keywords provided by AstraZeneca:
Non Small Cell Lung Cancer

Additional relevant MeSH terms:
Carcinoma
Carcinoma, Non-Small-Cell Lung
Lung Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Carcinoma, Bronchogenic
Bronchial Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Lung Diseases
Respiratory Tract Diseases
 Gefitinib
Carboplatin
Paclitaxel
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents, Phytogenic
Protein Kinase Inhibitors
Enzyme Inhibitors

ClinicalTrials.gov processed this record on May 22, 2013