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/study/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
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
Trial website
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

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results not provided in https://clinicaltrials.gov/study/NCT00252798