Non-Small-Cell Lung CancerPhase 2NCT01037998
UFUR (Tegafur/Uracil) Plus Iressa in Non-small-cell Lung Cancer
A Phase 2 study testing UFUR and Iressa in people with Non-Small-Cell Lung Cancer, run by Taipei Veterans General Hospital, Taiwan at 1 site in Taiwan.
Trial summary
Iressa [epidermal growth factor tyrosine kinase inhibitor (EGFR-TKI)] has been reported to activity against Non-small-cell Lung Cancer (NSCLC) failed previous chemotherapy. UFUR was found to have anti-angiogenesis effect when long term treatment was given. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Non-Small-Cell Lung Cancer
- What is being tested?
- UFUR and Iressa
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 115 participants
- Where
- 1 siteTaiwan
- Study dates
- Nov 2005to Dec 2009
- Phase
- Phase 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Histologic or cytological diagnosis of NSCLC who failed previous platinum-based and taxanes chemotherapy.
- No prior radiotherapy on measurable lesion(s).
- Performance status of 0 to 3 on the Zubrod scale. (Reference 1)
- Clinically measurable disease, defined as bidimensionally measurable lesions with clearly defined margins on x-ray, scan, or physical examination. Lesions serving as measurable disease must be at least 1 cm by 1 cm, as defined by CT scan, MRI, or chest x-ray.
- Informed consent from patient.
- Males or females 18 years of age or older.
- If female: childbearing potential either terminated by surgery, radiation, or menopause, or attenuated by use of an approved contraceptive method (intrauterine contraceptive device [IUD], birth control pills, or barrier device) during and for three months after trial.
Who cannot join
- Active infection (at the discretion of the investigator).
- Inadequate liver function (total bilirubin >1.5 times above normal range); alanine transaminase (ALT) and aspartate transaminase (AST) greater than 5 times normal.
- Inadequate renal function (creatinine >2.0 mg/dL).
- Breast feeding.
- Second primary malignancy (except in situ carcinoma of the cervix or adequately treated basal cell carcinoma of the skin)
- Concomitant myelosuppressive radiotherapy, chemotherapy, hormonal therapy, or immunotherapy will not be allowed except as for palliative radiation to non-measurable lesion.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Phase II Trial of Adding UFUR to Non-small-cell Lung Cancer Patients Treated With Iressa
Iressa [epidermal growth factor tyrosine kinase inhibitor (EGFR-TKI)] has been reported to activity against Non-small-cell Lung Cancer (NSCLC) failed previous chemotherapy. UFUR was found to have anti-angiogenesis effect when long term treatment was given. Combination of EGFR-TKI and anti-angiogenesis agents is a novel treatment.
Read the detailed description
Iressa is a selective epidermal growth factor receptor tyrosine kinase inhibitor (EGFR-TKI). It is an orally active agent for advanced non-small-cell lung cancer (NSCLC) in those who have failed a previous platinum-based regimen and taxane treatment. UFUR (Tegafur/Uracil) is effective agent against chemo-naïve NSCLC. It has anti-angiogenesis effect when used as long-term low dose treatment.
Present phase II randomized clinical trial is designed to answer whether or not adding an oral anti-angiogenesis agent (UFUR), that has low toxicity profiles when long term use, to EGFR-TKI (Iressa) could increase patients survival and response rate.
- Conditions
- Non-Small-Cell Lung Cancer
- Being tested
- UFUR and Iressa
- Keywords
- adenocarcinoma, non-small-cell lung cancer, gefitinib, UFUR
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung, Adenocarcinoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
UFUR and IressaDrug
Also called UFUR
Iressa 250 mg daily plus UFUR 1# bid
| Study group | Role | What they receive |
|---|---|---|
| A | Active comparator | Iressa 250 mg daily treatment plus UFUR twice daily treatment Receives: Drug: UFUR and Iressa |
| B | No intervention | Gefitinib 250 mg daily treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
To assess and compared the 6-month survival rate of these two arms of treatment.
Measured: 6 months
Secondary outcomes (1)
To assess and compared the progression-free survival, overall survival, the response rate, and the toxicity profiles of these two arms of treatment.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Dec 2009 (estimated)
- Study startNov 2005
- Primary completionDec 2009
- Study completionDec 2009
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 CancerStudies of the same condition, open and under way.
- More trials run by Taipei Veterans General Hospital, TaiwanThe 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 115 participants (actual)
Sponsor and investigators
- Lead sponsor
- Taipei Veterans General Hospital, Taiwan
- Sponsor type
- Other government
- Investigators
- Yuh-Min Chen, MD, PhD., Principal investigator, Chest Department, Taipei VGH
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01037998
- Sponsor's protocol ID
- 94-09-03
- Status last verified
- Dec 2009
- First submitted
- 27 May 2008
- Last updated
- 23 Dec 2009
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 23 Dec 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Trial of Adding UFUR to Non-small-cell Lung Cancer Patients Treated With Iressa
- ClinicalTrials.gov ID
- NCT01037998
- Acronym / sponsor ID
- 94-09-03
- Conditions
- Non-Small-Cell Lung Cancer
- Keywords
- adenocarcinoma, non-small-cell lung cancer, gefitinib, UFUR
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 115 participants (actual)
- Lead sponsor
- Taipei Veterans General Hospital, TaiwanOther government
- Study start
- Nov 2005
- Primary completion
- Dec 2009 (actual)
- Study completion
- Dec 2009 (actual)
- First posted
- 23 Dec 2009 (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.
Iressa [epidermal growth factor tyrosine kinase inhibitor (EGFR-TKI)] has been reported to activity against Non-small-cell Lung Cancer (NSCLC) failed previous chemotherapy. UFUR was found to have anti-angiogenesis effect when long term treatment was given. Combination of EGFR-TKI and anti-angiogenesis agents is a novel treatment.
Detailed description
Iressa is a selective epidermal growth factor receptor tyrosine kinase inhibitor (EGFR-TKI). It is an orally active agent for advanced non-small-cell lung cancer (NSCLC) in those who have failed a previous platinum-based regimen and taxane treatment. UFUR (Tegafur/Uracil) is effective agent against chemo-naïve NSCLC. It has anti-angiogenesis effect when used as long-term low dose treatment.
Present phase II randomized clinical trial is designed to answer whether or not adding an oral anti-angiogenesis agent (UFUR), that has low toxicity profiles when long term use, to EGFR-TKI (Iressa) could increase patients survival and response rate.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| A | Active comparator | Drug: UFUR and IressaIressa 250 mg daily treatment plus UFUR twice daily treatment |
| B | No intervention | –Gefitinib 250 mg daily treatment |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Histologic or cytological diagnosis of NSCLC who failed previous platinum-based and taxanes chemotherapy.
- No prior radiotherapy on measurable lesion(s).
- Performance status of 0 to 3 on the Zubrod scale. (Reference 1)
- Clinically measurable disease, defined as bidimensionally measurable lesions with clearly defined margins on x-ray, scan, or physical examination. Lesions serving as measurable disease must be at least 1 cm by 1 cm, as defined by CT scan, MRI, or chest x-ray.
- Informed consent from patient.
Key exclusion criteria (6 listed)
- Active infection (at the discretion of the investigator).
- Inadequate liver function (total bilirubin >1.5 times above normal range); alanine transaminase (ALT) and aspartate transaminase (AST) greater than 5 times normal.
- Inadequate renal function (creatinine >2.0 mg/dL).
- Breast feeding.
- Second primary malignancy (except in situ carcinoma of the cervix or adequately treated basal cell carcinoma of the skin)
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 |
|---|---|---|
| UFUR and IressaAlso: UFURIressa 250 mg daily plus UFUR 1# bid | Drug | A |
Primary outcome
To assess and compared the 6-month survival rate of these two arms of treatment.
Time frame: 6 months
1 secondary outcome
To assess and compared the progression-free survival, overall survival, the response rate, and the toxicity profiles of these two arms of treatment.
Time frame: 6 months
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 Dec 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.
Yuh-Min Chen, MD, PhD. principal investigator
Chest Department, Taipei VGH
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing UFUR and Iressa in people with Non-Small-Cell Lung Cancer, run by Taipei Veterans General Hospital, Taiwan at 1 site in Taiwan.
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 7 inclusion and 6 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 Dec 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 Taiwan. 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 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?
To assess and compared the 6-month survival rate of these two arms of treatment. (time frame: 6 months). 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 Dec 2009.