Carcinoma, Non-Small-Cell LungPhase 2NCT00625352
Study of Developing an Optimal Gemcitabine Based Regimen to Treat Elderly Patients With Advanced Non-Small Cell Carcinoma
A Phase 2 study testing Gemcitabine, UFT in people with Carcinoma, Non-Small-Cell Lung, run by Ulsan University Hospital at 1 site in South Korea.
Trial summary
Cares for elderly patients with advanced non-small cell lung cancer(NSCLC) become one of the common clinical practices oncologist are now facing. So, we need to seek adequate regimens for them. Gemcitabine is well known to be one of active third generation agents in terms of both efficacy and tolerability. Read more about this study
- Who is it for?
- Ages 70 years and older
- Conditions the study is for
- Carcinoma, Non-Small-Cell Lung
- What is being tested?
- Gemcitabine, UFT
- Type of treatment
- Injection or infusion
- How many people
- 48 participants
- Where
- 1 siteSouth Korea
- Study dates
- Feb 2008to 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 70 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- Histologically- or cytologically- confirmed Non-Small-Cell Lung Cancer Stage IIIB/IV
- No prior chemotherapy
- Existence of measurable disease. The measurable disease should not have been irradiated
- Life expectancy of more than 3 months
- Age ≥ 70 years
- Performance status (ECOG):1 or 2
Show all 9Show fewer
- Adequate bone marrow function (Absolute neutrophil count >1500/mm^3, Platelet count>100000/mm^3, Hemoglobin>9gr/mm^3)
- Adequate liver (Bilirubin<2 times upper limit of normal and SGOT/SGPT<3 times upper limit of normal) and renal function (creatinine<1.5mg/dl)
- Informed consent
Who cannot join
- Psychiatric illness or social situation that would preclude study compliance.
- Other concurrent uncontrolled illness.
- Other invasive malignancy within the past 5 years except nonmelanoma skin cancer
- Currently/recently taken warfarin, phenprocoumon or phenytoin
- Hypersensitivity history to any drug
Trial locations and contacts
1 site in 1 country.
South Korea1 site, 1 recruiting
- Recruiting
Ulsan University Hospital
Ulsan, 682-714
Jin Sun Yoon, 82-52-250-7010
About this study
Official title: Prospective Phase II Trial of a Combination of Gemcitabine and UFT as First-Line Treatment in Elderly Patients With Advanced Non-Small Cell Carcinoma
Cares for elderly patients with advanced non-small cell lung cancer(NSCLC) become one of the common clinical practices oncologist are now facing. So, we need to seek adequate regimens for them. Gemcitabine is well known to be one of active third generation agents in terms of both efficacy and tolerability. Gemcitabine alone have been recommended as first line treatment for elderly NSCLC patients, especially in the aspect of tolerability. However, gemcitabine alone is suggested to be suboptimal to control their disease. Therefore, we plan to make an optimal regimen containing gemcitabine for the elderly patients.
- Conditions
- Carcinoma, Non-Small-Cell Lung
- Being tested
- Gemcitabine, UFT
- Keywords
- Carcinoma, Non-Small-Cell Lung, Aged, Gemcitabine, UFT
- 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.
Gemcitabine, UFTDrug
Gemcitabine 1,250mg/m2 IV on D1 and D8 of every 3 weeks combined with UFT 400mg daily PO for 14 days every 3 weeks. Gemcitabine will be administered to patients a maximum of 4 cycles, and then discontinued. UFT will be continued until progression.
What is being measured
The primary outcome is the main question the study is designed to answer.
overall response rate
Measured: every two cycles
Secondary outcomes (1)
toxicity, response duration, progression free survival, overall survival
Measured: according to protocol
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Feb 2008 (estimated)
- Study startFeb 2008
- Primary completionDec 2009 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Carcinoma, Non-Small-Cell LungStudies of the same condition, open and under way.
- 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 48 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ulsan University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Jeil Pharmaceutical Co., Ltd.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00625352
- Sponsor's protocol ID
- UUH-ONC-0019
- Status last verified
- Feb 2008
- First submitted
- 19 Feb 2008
- Last updated
- 28 Feb 2008
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Feb 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Phase II Trial of a Combination of Gemcitabine and UFT as First-Line Treatment in Elderly Patients With Advanced Non-Small Cell Carcinoma
- ClinicalTrials.gov ID
- NCT00625352
- Acronym / sponsor ID
- UUH-ONC-0019
- Conditions
- Carcinoma, Non-Small-Cell Lung
- Keywords
- Carcinoma, Non-Small-Cell Lung, Aged, Gemcitabine, UFT
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 48 participants (estimated)
- Lead sponsor
- Ulsan University HospitalUniversity, hospital or other
- Collaborators
- Jeil Pharmaceutical Co., Ltd.
- Study start
- Feb 2008
- Primary completion
- Dec 2009 (estimated)
- First posted
- 28 Feb 2008 (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.
Cares for elderly patients with advanced non-small cell lung cancer(NSCLC) become one of the common clinical practices oncologist are now facing. So, we need to seek adequate regimens for them. Gemcitabine is well known to be one of active third generation agents in terms of both efficacy and tolerability. Gemcitabine alone have been recommended as first line treatment for elderly NSCLC patients, especially in the aspect of tolerability. However, gemcitabine alone is suggested to be suboptimal to control their disease. Therefore, we plan to make an optimal regimen containing gemcitabine for the elderly patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 70 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (9 listed)
- Histologically- or cytologically- confirmed Non-Small-Cell Lung Cancer Stage IIIB/IV
- No prior chemotherapy
- Existence of measurable disease. The measurable disease should not have been irradiated
- Life expectancy of more than 3 months
- Age ≥ 70 years
Key exclusion criteria (5 listed)
- Psychiatric illness or social situation that would preclude study compliance.
- Other concurrent uncontrolled illness.
- Other invasive malignancy within the past 5 years except nonmelanoma skin cancer
- Currently/recently taken warfarin, phenprocoumon or phenytoin
- Hypersensitivity history to any drug
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 |
|---|---|---|
| Gemcitabine, UFTGemcitabine 1,250mg/m2 IV on D1 and D8 of every 3 weeks combined with UFT 400mg daily PO for 14 days every 3 weeks. Gemcitabine will be administered to patients a maximum of 4 cycles, and then discontinued. UFT will be continued until progression. | Drug | – |
Primary outcome
overall response rate
Time frame: every two cycles
1 secondary outcome
toxicity, response duration, progression free survival, overall survival
Time frame: according to protocol
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Feb 2008.
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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.
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 Gemcitabine, UFT in people with Carcinoma, Non-Small-Cell Lung, run by Ulsan University Hospital at 1 site in South Korea.
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 9 inclusion and 5 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: status not confirmed, as of the sponsor's last update on 28 Feb 2008. 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 South Korea. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Young Joo Min, M.D. (82-52-250-8832, yjmin@uuh.ulsan.kr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
overall response rate (time frame: every two cycles). 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 28 Feb 2008.