Pancreatic NeoplasmPhase 2NCT00436423
A Phase Ⅱ Study of Gemcitabine Combination With TS-1 in Patient With Advanced or Recurred Pancreatic Cancer
A Phase 2 study testing gemcitabine, TS-1 in people with Pancreatic Neoplasm and Neoplasm Metastasis, run by Korea University Anam Hospital at 1 site in South Korea.
Trial summary
The primary objective of the study is to Evaluate the response rate of Gemcitabine with TS-1 in Korean patient with advanced but inoperable, metastatic or recurrent pancreatic cancer who is not receiving anti cancer therapy. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pancreatic Neoplasm, Neoplasm Metastasis
- What is being tested?
- gemcitabine, TS-1
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 38 participants
- Where
- 1 siteSouth Korea
- Study dates
- Mar 2006to not given
- 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
- histologically or cytologically confirmed adenocarcinoma with inoperable locally advanced or metastatic or recurrent pancreatic cancer after previous operation or radiation therapy
- performance statues 0,1 or 2 on the ECOG scale
- life expectance of at least 3 months
- adequate organ function including the following <adequatebone marrow function> Absolute neutrophil count(ANC) ≥ 1.5 � 109/L Platelets ≥ 100 � 109/L Hemoglobin ≥ 9 g/dL <adequate hepatic function> Serum AST, ALT< 5 X upper limit of normal(ULT) serum bilirubin< 2 X ULT Patient with obstructive jaundice and serum bilirubin more than double of upper limit of normal have to drain bile internally or externally before enrolment.
- <adequate renal function> Creatinine < 1.5 X ULT
- consent form which is voluntarily signed by patients or legal representative
Show all 10Show fewer
- men or women , age 18
- previous chemotherapy is not allowed. But previous adjuvant or neo adjuvant chemotherapy is allowed Patient must completed previous adjuvant or neo adjuvant chemotherapy at least one month.
- Patient must have recovered from the toxic effect of the treatment But patient who are to receive gemcitabin and TS-1 on previous adjuvant or neo adjuvant chemotherapy must not be enrolled.
- Measurable disease, according to the response Evaluation criteria in solid tumors(RECIST), assessed using imaging techniques(CT or MRI)
Who cannot join
- have received treatment within the last 30 days of study enrolment with a drug that has not received approval for any indication
- heart failure, angina pectoris or arrhythmia which is uncontrolledwith medication within the previous 6 month .
- serious neurological or mental disorder.
- active infection that would compromise the patient's ability to stand the study, at the discretion of the investigator.
- uncontrolled diabetes.
- serious concomitant disorders that would compromisethe safety of the patient or compromise the patient's ability to complete the study, at the discretion of the investigator.
- pregnancy
- breast feeding.
Trial locations and contacts
1 site in 1 country.
About this study
The primary objective of the study is to Evaluate the response rate of Gemcitabine with TS-1 in Korean patient with advanced but inoperable, metastatic or recurrent pancreatic cancer who is not receiving anti cancer therapy.
Read the detailed description
To date, curative treatment of pancreatic cancer is surgery.But patients with operable indication are rare, most of patients present with locally advanced or general advanced stage at diagnosis. Thus the majority of patients need chemotherapy.But efficacy outcomes have not seemed to increase overall survival comparing with none treated control group.In Korea the incidence of pancreatic cancer increases steadily. Prognosis is poor. So now the effective treatment is necessary.There are no phase 2 trialsabout combining gemcitabine and TS-1 against advanced pancreatic cancer.according to phase 1 trial of advanced pancreatic cancer (nakamura et al)toxicities more than 3 grade are neutropenia, anemia, thrombocytopenia, anorexia, etc that can be treated.Phase 1 trial is not study to evaluate the response rate. But among 21 patients who can be evaluated the response rate, 10 patients have Partial response or Complete response.This combination therapy seemed to havetolerable toxicity and remarkable therapeutic effect for locally advanced or metastatic pancreatic cancer.So therapy combining gemcitabine with TS-1 is expected synergic and additional effect.
This trial is phase 2, open-label, multi-center, single arm study The total sample size will be 38 patients. Patient will be administered chemotherapy until disease progression. Gemcitabine will be administered at a dose of 1000 mg/m2 every 3weeks (on day 1 of each cycle) TS-1 will be administered 80 mg/m2 orally twice daily for 14 days every 3 weeks.
- Conditions
- Pancreatic Neoplasm, Neoplasm Metastasis
- Being tested
- gemcitabine, TS-1
- Keywords
- pancreatic neoplasm, drug therapy, gemcitabine, TS-1
- Medical subject headings
- Pancreatic Neoplasms, Neoplasm Metastasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
gemcitabine, TS-1Drug
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Gemcitabine with TS-1 Receives: Drug: gemcitabine, TS-1 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Response rate by RECIST criteria
Secondary outcomes (2)
Describe quantitative and qualitative toxicity of gemcitabine with TS-1
Evaluate the following efficacy measure Duration of response,Time to treatment failure,Time to documented disease progression, Overall survival
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Feb 2007 (estimated)
- Study startMar 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pancreatic NeoplasmStudies 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
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 38 participants (actual)
Sponsor and investigators
- Lead sponsor
- Korea University Anam Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Seoul National University Hospital, Seoul Municipal Boramae Hospital, Konkuk University Hospital, Korea University Ansan Hospital, Seoul National University Bundang Hospital, Korea University Guro Hospital
- Investigators
- YeulHong Kim, professor, Principal investigator, Korea University Anam Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00436423
- Sponsor's protocol ID
- AN0561-008
- Status last verified
- Oct 2007
- First submitted
- 16 Feb 2007
- Last updated
- 1 Nov 2007
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Nov 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase Ⅱ Study of Gemcitabine Combination With TS-1 in Patient With Advanced or Recurred Pancreatic Cancer
- ClinicalTrials.gov ID
- NCT00436423
- Acronym / sponsor ID
- AN0561-008
- Conditions
- Pancreatic Neoplasm, Neoplasm Metastasis
- Keywords
- pancreatic neoplasm, drug therapy, gemcitabine, TS-1
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 38 participants (actual)
- Lead sponsor
- Korea University Anam HospitalUniversity, hospital or other
- Collaborators
- Seoul National University Hospital, Seoul Municipal Boramae Hospital, Konkuk University Hospital, Korea University Ansan Hospital, Seoul National University Bundang Hospital, Korea University Guro Hospital
- Study start
- Mar 2006
- First posted
- 19 Feb 2007 (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 study is to Evaluate the response rate of Gemcitabine with TS-1 in Korean patient with advanced but inoperable, metastatic or recurrent pancreatic cancer who is not receiving anti cancer therapy.
Detailed description
To date, curative treatment of pancreatic cancer is surgery.But patients with operable indication are rare, most of patients present with locally advanced or general advanced stage at diagnosis. Thus the majority of patients need chemotherapy.But efficacy outcomes have not seemed to increase overall survival comparing with none treated control group.In Korea the incidence of pancreatic cancer increases steadily. Prognosis is poor. So now the effective treatment is necessary.There are no phase 2 trialsabout combining gemcitabine and TS-1 against advanced pancreatic cancer.according to phase 1 trial of advanced pancreatic cancer (nakamura et al)toxicities more than 3 grade are neutropenia, anemia, thrombocytopenia, anorexia, etc that can be treated.Phase 1 trial is not study to evaluate the response rate. But among 21 patients who can be evaluated the response rate, 10 patients have Partial response or Complete response.This combination therapy seemed to havetolerable toxicity and remarkable therapeutic effect for locally advanced or metastatic pancreatic cancer.So therapy combining gemcitabine with TS-1 is expected synergic and additional effect.
This trial is phase 2, open-label, multi-center, single arm study The total sample size will be 38 patients. Patient will be administered chemotherapy until disease progression. Gemcitabine will be administered at a dose of 1000 mg/m2 every 3weeks (on day 1 of each cycle) TS-1 will be administered 80 mg/m2 orally twice daily for 14 days every 3 weeks.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: gemcitabine, TS-1Gemcitabine with TS-1 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- histologically or cytologically confirmed adenocarcinoma with inoperable locally advanced or metastatic or recurrent pancreatic cancer after previous operation or radiation therapy
- performance statues 0,1 or 2 on the ECOG scale
- life expectance of at least 3 months
- adequate organ function including the following <adequatebone marrow function> Absolute neutrophil count(ANC) ≥ 1.5 � 109/L Platelets ≥ 100 � 109/L Hemoglobin ≥ 9 g/dL <adequate hepatic function> Serum AST, ALT< 5 X upper limit of normal(ULT) serum bilirubin< 2 X ULT Patient with obstructive jaundice and serum bilirubin more than double of upper limit of normal have to drain bile internally or externally before enrolment.
- <adequate renal function> Creatinine < 1.5 X ULT
Key exclusion criteria (8 listed)
- have received treatment within the last 30 days of study enrolment with a drug that has not received approval for any indication
- heart failure, angina pectoris or arrhythmia which is uncontrolledwith medication within the previous 6 month .
- serious neurological or mental disorder.
- active infection that would compromise the patient's ability to stand the study, at the discretion of the investigator.
- uncontrolled diabetes.
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, TS-1 | Drug | 1 |
Primary outcome
Response rate by RECIST criteria
2 secondary outcomes
Describe quantitative and qualitative toxicity of gemcitabine with TS-1
Evaluate the following efficacy measure Duration of response,Time to treatment failure,Time to documented disease progression, Overall survival
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 1 Nov 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.
YeulHong Kim, professor principal investigator
Korea University Anam Hospital
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, TS-1 in people with Pancreatic Neoplasm and Neoplasm Metastasis, run by Korea University Anam 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 10 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 1 Nov 2007. 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?
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?
Response rate by RECIST criteria. 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 1 Nov 2007.