Non Small Cell Lung CarcinomaPhase 1NCT00252798
ZD1839 (Iressa™) and Concurrent Chemo-Radiation in Patients With Locally Advanced Non Small Cell Lung Cancer
A Phase 1 study testing Gefitinib, Carboplatin and Paclitaxel in people with Non Small Cell Lung Carcinoma, run by AstraZeneca at 2 sites in Australia.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Non Small Cell Lung Carcinoma
- What is being tested?
- Gefitinib, Carboplatin and Paclitaxel
- Type of treatment
- Surgery or procedure
- How many people
- 44 participants
- Where
- 2 sitesAustralia
- Study dates
- Jul 2002to Oct 2005
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country.
Australia2 sites
Research Site
East Melbourne, Victoria
Research Site
Woolloonabba, Queensland
About this study
Official title: A Phase I Trial to Evaluate ZD1839(Iressa™) and Concurrent Chemo-Radiation in Patients With Locally Advanced Non Small Cell Lung Cancer
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.
- Conditions
- Non Small Cell Lung Carcinoma
- Being tested
- Gefitinib, Carboplatin, Paclitaxel, Radiation
- Keywords
- Non Small Cell Lung Cancer
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GefitinibDrug
CarboplatinDrug
PaclitaxelDrug
RadiationProcedure or surgery
What is being measured
The primary outcome is the main question the study is designed to answer.
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
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)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Nov 2005 (estimated)
- Study startJul 2002
- Study completionOct 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non Small Cell Lung CarcinomaStudies of the same condition, open and under way.
- More trials run by AstraZenecaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 44 participants
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- AstraZeneca Australia Medical Director, MD, Study director, AstraZeneca
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00252798
- Sponsor's protocol ID
- D7913C00073
- Other IDs
- 1839IL/0073
- Status last verified
- Dec 2007
- First submitted
- 1 Nov 2005
- Last updated
- 19 Dec 2007
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Dec 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I Trial to Evaluate ZD1839(Iressa™) and Concurrent Chemo-Radiation in Patients With Locally Advanced Non Small Cell Lung Cancer
- ClinicalTrials.gov ID
- NCT00252798
- Acronym / sponsor ID
- D7913C00073
- Conditions
- Non Small Cell Lung Carcinoma
- Keywords
- Non Small Cell Lung Cancer
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 44 participants
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- Jul 2002
- Study completion
- Oct 2005 (actual)
- First posted
- 15 Nov 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (8 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Gefitinib | Drug | – |
| Carboplatin | Drug | – |
| Paclitaxel | Drug | – |
| Radiation | Procedure or surgery | – |
Primary outcome
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.
8 secondary outcomes
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)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Dec 2007.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
AstraZeneca Australia Medical Director, MD study director
AstraZeneca
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Gefitinib, Carboplatin and Paclitaxel in people with Non Small Cell Lung Carcinoma, run by AstraZeneca at 2 sites in Australia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Dec 2007. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Dec 2007.