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

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ClinicalTrials.gov Identifier: NCT00252798
Recruitment Status : Completed
First Posted : November 15, 2005
Last Update Posted : December 19, 2007
Sponsor:
Information provided by:
AstraZeneca

Brief 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.

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

Study Type : Interventional  (Clinical Trial)
Enrollment : 44 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (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
Study Start Date : July 2002
Actual Study Completion Date : October 2005

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lung Cancer
Drug Information available for: Gefitinib




Primary Outcome Measures :
  1. 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 :
  1. To evaluate the activity potential of the combination of ZD1839, carboplatin, paclitaxel & radiation therapy
  2. Estimating the objective response rate (complete response [CR] & partial response [PR]) as assessed by positron emission tomography with (18F)-labelled fluorodeoxyglucose (PET-FDG)
  3. To estimate the objective response rate (CR and PR) as assessed by computerised tomography (CT) scan
  4. To estimate the complete response rate (CR) as assessed by PET-FDG
  5. To estimate progression free survival (PFS) as assessed by clinical examination, chest x-ray, CT scan ± PET-FDG
  6. To estimate overall survival
  7. To characterise the safety and tolerability of ZD1839 combined with concurrent carboplatin, paclitaxel and radiation
  8. To determine the site of first failure (characterised as local-regional, distant or both)


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

ClinicalTrials.gov Identifier: NCT00252798     History of Changes
Other Study ID Numbers: D7913C00073
1839IL/0073
First Posted: November 15, 2005    Key Record Dates
Last Update Posted: December 19, 2007
Last Verified: December 2007

Keywords provided by AstraZeneca:
Non Small Cell Lung Cancer

Additional relevant MeSH terms:
Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms
Gefitinib
Carboplatin
Antineoplastic Agents
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action