ZD1839 (Iressa™) and Concurrent Chemo-Radiation in Patients With Locally Advanced Non Small Cell Lung Cancer
A Phase I Trial to Evaluate ZD1839(Iressa™) and Concurrent Chemo-Radiation in Patients With Locally Advanced Non Small Cell Lung Cancer
2 other identifiers
interventional
44
1 country
2
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 Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_1
Started Jul 2002
Typical duration for phase_1
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 1, 2002
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2005
CompletedFirst Submitted
Initial submission to the registry
November 1, 2005
CompletedFirst Posted
Study publicly available on registry
November 15, 2005
CompletedDecember 19, 2007
December 1, 2007
November 1, 2005
December 16, 2007
Conditions
Keywords
Outcome Measures
Primary Outcomes (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 Outcomes (8)
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
- +3 more secondary outcomes
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- AstraZenecalead
Study Sites (2)
Research Site
Woolloonabba, Queensland, Australia
Research Site
East Melbourne, Victoria, Australia
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
AstraZeneca Australia Medical Director, MD
AstraZeneca
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
November 1, 2005
First Posted
November 15, 2005
Study Start
July 1, 2002
Study Completion
October 1, 2005
Last Updated
December 19, 2007
Record last verified: 2007-12