Pancreatic CancerPhase 1/2NCT00234416
IRESSA Combined With Radiotherapy & Gemcitabine as First-Line Treatment in Locally Advanced Pancreatic Cancer
A Phase 1/2 study testing Gefitinib and Gemcitabine in people with Pancreatic Cancer, run by AstraZeneca at 2 sites in Spain.
Trial summary
The primary objective of the trial is to identify the dose of gemcitabine given as a 2-hour intravenous (iv) infusion that can be administered in combination with ZD1839 250 mg once daily and a standard course (45 Grays [Gy]) of radiotherapy in patients with locally advanced, unresectable pancreatic cancer. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Pancreatic Cancer
- What is being tested?
- Gefitinib and Gemcitabine
- How many people
- 45 participants
- Where
- 2 sitesSpain
- Study dates
- Aug 2002to Mar 2005
- 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 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Histologically confirmed pancreatic cancer (aspiration biopsy by fine needle [PAAF] by USE or biopsy guide by ECO-CT). It is mandatory the diagnostic by USE and will recommend the aspiration biopsy with this technique
- Tumoural volume by TAC < 500 cc
- Aged 18 to 75 years inclusive
- Eastern Cooperative Oncology Group (ECOG) performance status (PS) £ 1
- Life-expectancy of more than 12 weeks
- Women of child-bearing potential must be willing to practice reliable methods of birth control to prevent pregnancy
Who cannot join
- Previous radiotherapy or chemotherapy for malignant disease
- Other co-existing malignancies or malignancies diagnosed within the last 5 years with the exception of basal cell carcinoma or cervical cancer in situ
- In the opinion of the investigator, any evidence of severe or uncontrolled systemic disease (e.g. unstable or uncompensated respiratory, cardiac, hepatic or renal disease)
- Absolute neutrophil count (ANC) less than 1.5 x 109/litre (L), platelets less than 100 x 109/L or haemoglobin less than 9 mg/dL; Prothrombin time (PT) less than 50%; Serum bilirubin greater than 2.5 times the upper limit of reference range (ULRR; Creatinine clearance less than 45 mL/min; ALT or AST greater than 2.5 times the ULRR
- Active dermatoses (e.g. psoriasis, eczema)
- Concomitant use of phenytoin, carbamazepine, barbiturates, rifampicin, or drugs with known corneal toxicity
- Known, severe hypersensitivity to ZD1839 or any of the excipients of this product
Trial locations and contacts
2 sites in 1 country.
About this study
Official title: A Trial to Evaluate ZD1839 (IRESSA) in Combination With Radiotherapy & Gemcitabine as First-Line Treatment in Patients With Locally Advanced Pancreatic Cancer
The primary objective of the trial is to identify the dose of gemcitabine given as a 2-hour intravenous (iv) infusion that can be administered in combination with ZD1839 250 mg once daily and a standard course (45 Grays [Gy]) of radiotherapy in patients with locally advanced, unresectable pancreatic cancer.
- Conditions
- Pancreatic Cancer
- Being tested
- Gefitinib, Gemcitabine
- Keywords
- Pancreatic Cancer, EGF-R
- Medical subject headings
- Pancreatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GefitinibDrug
GemcitabineDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of DLT
Secondary outcomes (2)
Overall objective tumour response (CR and PR) based on the Response Evaluation Criteria in Solid Tumours (RECIST), assessed by abdominal CT (abdominal scan)
Nature, incidence and severity of adverse events (AEs) and serious adverse events (SAEs)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Oct 2005 (estimated)
- Study startAug 2002
- Study completionMar 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pancreatic CancerStudies 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
- 45 participants
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- AstraZeneca Spain Medical Director, MD, Study director, AstraZeneca Spain
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00234416
- Sponsor's protocol ID
- 1839IL/0100
- Status last verified
- Apr 2009
- First submitted
- 5 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
- A Trial to Evaluate ZD1839 (IRESSA) in Combination With Radiotherapy & Gemcitabine as First-Line Treatment in Patients With Locally Advanced Pancreatic Cancer
- ClinicalTrials.gov ID
- NCT00234416
- Acronym / sponsor ID
- 1839IL/0100
- Conditions
- Pancreatic Cancer
- Keywords
- Pancreatic Cancer, EGF-R
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 45 participants
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- Aug 2002
- Study completion
- Mar 2005 (actual)
- First posted
- 7 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.
The primary objective of the trial is to identify the dose of gemcitabine given as a 2-hour intravenous (iv) infusion that can be administered in combination with ZD1839 250 mg once daily and a standard course (45 Grays [Gy]) of radiotherapy in patients with locally advanced, unresectable pancreatic cancer.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Histologically confirmed pancreatic cancer (aspiration biopsy by fine needle [PAAF] by USE or biopsy guide by ECO-CT). It is mandatory the diagnostic by USE and will recommend the aspiration biopsy with this technique
- Tumoural volume by TAC < 500 cc
- Aged 18 to 75 years inclusive
- Eastern Cooperative Oncology Group (ECOG) performance status (PS) £ 1
- Life-expectancy of more than 12 weeks
Key exclusion criteria (7 listed)
- Previous radiotherapy or chemotherapy for malignant disease
- Other co-existing malignancies or malignancies diagnosed within the last 5 years with the exception of basal cell carcinoma or cervical cancer in situ
- In the opinion of the investigator, any evidence of severe or uncontrolled systemic disease (e.g. unstable or uncompensated respiratory, cardiac, hepatic or renal disease)
- Absolute neutrophil count (ANC) less than 1.5 x 109/litre (L), platelets less than 100 x 109/L or haemoglobin less than 9 mg/dL; Prothrombin time (PT) less than 50%; Serum bilirubin greater than 2.5 times the upper limit of reference range (ULRR; Creatinine clearance less than 45 mL/min; ALT or AST greater than 2.5 times the ULRR
- Active dermatoses (e.g. psoriasis, eczema)
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 | – |
| Gemcitabine | Drug | – |
Primary outcome
Incidence of DLT
2 secondary outcomes
Overall objective tumour response (CR and PR) based on the Response Evaluation Criteria in Solid Tumours (RECIST), assessed by abdominal CT (abdominal scan)
Nature, incidence and severity of adverse events (AEs) and serious adverse events (SAEs)
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 23 Apr 2009.
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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 Spain Medical Director, MD study director
AstraZeneca Spain
2 sites 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 and Gemcitabine in people with Pancreatic Cancer, run by AstraZeneca at 2 sites in Spain.
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 6 inclusion and 7 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 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 2 sites in Spain. 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 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?
Incidence of DLT. 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.