Trial Review

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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT00252798




Registration number
NCT00252798
Ethics application status
Date submitted
1/11/2005
Date registered
15/11/2005
Date last updated
19/12/2007

Titles & IDs
Public title
ZD1839 (Iressa™) and Concurrent Chemo-Radiation in Patients With Locally Advanced Non Small Cell Lung Cancer
Scientific title
A Phase I Trial to Evaluate ZD1839(Iressa™) and Concurrent Chemo-Radiation in Patients With Locally Advanced Non Small Cell Lung Cancer
Secondary ID [1] 0 0
1839IL/0073
Secondary ID [2] 0 0
D7913C00073
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Non Small Cell Lung Carcinoma 0 0
Condition category
Condition code
Cancer 0 0 0 0
Lung - Mesothelioma
Cancer 0 0 0 0
Lung - Non small cell
Cancer 0 0 0 0
Lung - Small cell

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Gefitinib
Treatment: Drugs - Carboplatin
Treatment: Drugs - Paclitaxel
Treatment: Surgery - Radiation

Treatment: Drugs: Gefitinib


Treatment: Drugs: Carboplatin


Treatment: Drugs: Paclitaxel


Treatment: Surgery: Radiation
Intervention code [1] 0 0
Treatment: Drugs
Intervention code [2] 0 0
Treatment: Surgery
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
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.
Timepoint [1] 0 0
Secondary outcome [1] 0 0
To evaluate the activity potential of the combination of ZD1839, carboplatin, paclitaxel & radiation therapy
Timepoint [1] 0 0
Secondary outcome [2] 0 0
Estimating the objective response rate (complete response [CR] & partial response [PR]) as assessed by positron emission tomography with (18F)-labelled fluorodeoxyglucose (PET-FDG)
Timepoint [2] 0 0
Secondary outcome [3] 0 0
To estimate the objective response rate (CR and PR) as assessed by computerised tomography (CT) scan
Timepoint [3] 0 0
Secondary outcome [4] 0 0
To estimate the complete response rate (CR) as assessed by PET-FDG
Timepoint [4] 0 0
Secondary outcome [5] 0 0
To estimate progression free survival (PFS) as assessed by clinical examination, chest x-ray, CT scan ± PET-FDG
Timepoint [5] 0 0
Secondary outcome [6] 0 0
To estimate overall survival
Timepoint [6] 0 0
Secondary outcome [7] 0 0
To characterise the safety and tolerability of ZD1839 combined with concurrent carboplatin, paclitaxel and radiation
Timepoint [7] 0 0
Secondary outcome [8] 0 0
To determine the site of first failure (characterised as local-regional, distant or both)
Timepoint [8] 0 0

Eligibility
Key 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
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Phase 1
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/07/2002
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/10/2005
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
QLD,VIC
Recruitment hospital [1] 0 0
Research Site - Woolloonabba
Recruitment hospital [2] 0 0
Research Site - East Melbourne
Recruitment postcode(s) [1] 0 0
- Woolloonabba
Recruitment postcode(s) [2] 0 0
- East Melbourne

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
AstraZeneca
Address
Country

Ethics approval
Ethics application status

Summary
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.
Trial website
https://clinicaltrials.gov/ct2/show/NCT00252798
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
AstraZeneca Australia Medical Director, MD
Address 0 0
AstraZeneca
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT00252798