Back to resultsZD1839 (Iressa™) and Concurrent Chemo-Radiation in Patients With Locally Advanced Non Small Cell Lung Cancer
Primary Purpose
Non Small Cell Lung Carcinoma
Status
Completed
Phase
Phase 1
Locations
Australia
Study Type
Interventional
Intervention
Gefitinib
Carboplatin
Paclitaxel
Radiation
Sponsored by
About this trial
This is an interventional treatment trial for Non Small Cell Lung Carcinoma focused on measuring Non Small Cell Lung Cancer
Eligibility 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
Sites / Locations
- Research Site
- Research Site
Outcomes
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)
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00252798
Brief Title
ZD1839 (Iressa™) and Concurrent Chemo-Radiation in Patients With Locally Advanced Non Small Cell Lung Cancer
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 Type
Interventional
2. Study Status
Record Verification Date
December 2007
Overall Recruitment Status
Completed
Study Start Date
July 2002 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
October 2005 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
AstraZeneca
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Non Small Cell Lung Carcinoma
Keywords
Non Small Cell Lung Cancer
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
44 (false)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Gefitinib
Intervention Type
Drug
Intervention Name(s)
Carboplatin
Intervention Type
Drug
Intervention Name(s)
Paclitaxel
Intervention Type
Procedure
Intervention Name(s)
Radiation
Primary Outcome Measure Information:
Title
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 Measure Information:
Title
To evaluate the activity potential of the combination of ZD1839, carboplatin, paclitaxel & radiation therapy
Title
Estimating the objective response rate (complete response [CR] & partial response [PR]) as assessed by positron emission tomography with (18F)-labelled fluorodeoxyglucose (PET-FDG)
Title
To estimate the objective response rate (CR and PR) as assessed by computerised tomography (CT) scan
Title
To estimate the complete response rate (CR) as assessed by PET-FDG
Title
To estimate progression free survival (PFS) as assessed by clinical examination, chest x-ray, CT scan ± PET-FDG
Title
To estimate overall survival
Title
To characterise the safety and tolerability of ZD1839 combined with concurrent carboplatin, paclitaxel and radiation
Title
To determine the site of first failure (characterised as local-regional, distant or both)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
AstraZeneca Australia Medical Director, MD
Organizational Affiliation
AstraZeneca
Official's Role
Study Director
Facility Information:
Facility Name
Research Site
City
Woolloonabba
State/Province
Queensland
Country
Australia
Facility Name
Research Site
City
East Melbourne
State/Province
Victoria
Country
Australia
12. IPD Sharing Statement
Learn more about this trial
ZD1839 (Iressa™) and Concurrent Chemo-Radiation in Patients With Locally Advanced Non Small Cell Lung Cancer
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