Subjects With Resectable Local or Locally Advanced, Non-Metastatic (T2-T4, N0-N3, M0; Stages II and III) and Histologically-Confirmed Intestinal GCPhase 1/2NCT00237900
Gefitinib in Combination With Chemoradiation in Resectable Gastric Cancer
A Phase 1/2 study testing Gefitinib, 5-fluorouracil, leucovorin and radiotherapy in people with Subjects With Resectable Local or Locally Advanced, Non-Metastatic (T2-T4, N0-N3, M0; Stages II and III) and Histologically-Confirmed Intestinal GC, run by AstraZeneca at 1 site in Finland.
Trial summary
To assess safety, efficacy and explorative objectives of gefitinib in combination with chemoradiation in resectable gastric cancer Read more about this study
- Who is it for?
- Ages 45 to 70 years
- Conditions the study is for
- Subjects With Resectable Local or Locally Advanced, Non-Metastatic (T2-T4, N0-N3, M0; Stages II and III) and Histologically-Confirmed Intestinal GC
- What is being tested?
- Gefitinib, 5-fluorouracil, leucovorin and radiotherapy
- How many people
- 34 participants
- Where
- 1 siteFinland
- Study dates
- Jul 2003to Feb 2004
- Phase
- Phase 1/2
- 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 45 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Histologically-confirmed intestinal GC (T2-T4)
- Local or locally advanced stage II or stage III gastric cancer of an upper part of the stomach or GE junction
- Lymph node positive or negative
- Metastasis negative
- Resection with curative intent (R0, D2)
- Chemo- and radiotherapy naïve
- Measurable lesion according RECIST
- Written informed consent
Who cannot join
- Aged below 45 or over 70
- Prior gastric surgery
- Active ILD
Trial locations and contacts
1 site in 1 country.
About this study
Official title: An Open, Single.Centre, Phase I/II Study of ZD1839 (Iressa) in Combination With 5-Fluorouracil, Leucovorin and Radiotherapy in Subjects With Resectable Gastric Cancer
To assess safety, efficacy and explorative objectives of gefitinib in combination with chemoradiation in resectable gastric cancer
- Being tested
- Gefitinib, 5-fluorouracil, leucovorin and radiotherapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Gefitinib, 5-fluorouracil, leucovorin and radiotherapyDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Part 1: Safety and tolerability of gefitinib 250 mg in combination with radiotherapy (incidence of DLTs)
Parts 2 and 3: Safety and tolerability of gefitinib in combination with 5-FU, LV and radiotherapy
Secondary outcomes (4)
Parts 2 and 3:
Objective tumour response rate a week before surgery (CR and PR, RECIST criteria).
Objective histological response rate in dissected GC specimens taken at surgery, estimated using Evans/Pisters scores
Exploratory outcome: Parts 2 and 3: sVEGF levels, EGFR activation, Biomarkers such as cyclin D1, IL-1, GI-associated TOP2A, GAS, EST AA552509
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Oct 2005 (estimated)
- Study startJul 2003
- Study completionFeb 2004
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Subjects With Resectable Local or Locally Advanced, Non-Metastatic (T2-T4, N0-N3, M0; Stages II and III) and Histologically-Confirmed Intestinal GCStudies 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 1/2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 34 participants
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- AstraZeneca Oncology Medical Science Director, MD, Study director, AstraZeneca
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00237900
- Sponsor's protocol ID
- 1839IL/0539
- Status last verified
- Apr 2009
- First submitted
- 12 Oct 2005
- Last updated
- 23 Apr 2009
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Apr 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open, Single.Centre, Phase I/II Study of ZD1839 (Iressa) in Combination With 5-Fluorouracil, Leucovorin and Radiotherapy in Subjects With Resectable Gastric Cancer
- ClinicalTrials.gov ID
- NCT00237900
- Acronym / sponsor ID
- 1839IL/0539
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 34 participants
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- Jul 2003
- Study completion
- Feb 2004 (actual)
- First posted
- 13 Oct 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.
To assess safety, efficacy and explorative objectives of gefitinib in combination with chemoradiation in resectable gastric cancer
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 45 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Histologically-confirmed intestinal GC (T2-T4)
- Local or locally advanced stage II or stage III gastric cancer of an upper part of the stomach or GE junction
- Lymph node positive or negative
- Metastasis negative
- Resection with curative intent (R0, D2)
Key exclusion criteria (3 listed)
- Aged below 45 or over 70
- Prior gastric surgery
- Active ILD
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, 5-fluorouracil, leucovorin and radiotherapy | Drug | – |
Primary outcome
Part 1: Safety and tolerability of gefitinib 250 mg in combination with radiotherapy (incidence of DLTs)
Parts 2 and 3: Safety and tolerability of gefitinib in combination with 5-FU, LV and radiotherapy
4 secondary outcomes
Parts 2 and 3:
Objective tumour response rate a week before surgery (CR and PR, RECIST criteria).
Objective histological response rate in dissected GC specimens taken at surgery, estimated using Evans/Pisters scores
Exploratory outcome: Parts 2 and 3: sVEGF levels, EGFR activation, Biomarkers such as cyclin D1, IL-1, GI-associated TOP2A, GAS, EST AA552509
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Apr 2009.
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 Oncology Medical Science Director, MD study director
AstraZeneca
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Gefitinib, 5-fluorouracil, leucovorin and radiotherapy in people with Subjects With Resectable Local or Locally Advanced, Non-Metastatic (T2-T4, N0-N3, M0; Stages II and III) and Histologically-Confirmed Intestinal GC, run by AstraZeneca at 1 site in Finland.
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 8 inclusion and 3 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: stopped early, as of the sponsor's last update on 23 Apr 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Finland. 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 combined 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.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 was stopped early. Results are not available in the source record.
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?
Part 1: Safety and tolerability of gefitinib 250 mg in combination with radiotherapy (incidence of DLTs). The study lists 2 primary outcomes in all. 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 23 Apr 2009.