18 Years
N/A
Both
Pancreatic Neoplasm, Neoplasm Metastasis
Trial Information
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.
Inclusion Criteria:
1. histologically or cytologically confirmed adenocarcinoma with inoperable locally
advanced or metastatic or recurrent pancreatic cancer after previous operation or
radiation therapy
2. performance statues 0,1 or 2 on the ECOG scale
3. life expectance of at least 3 months
4. adequate organ function including the following
Absolute neutrophil count(ANC) ≥ 1.5 � 109/L Platelets ≥ 100 � 109/L Hemoglobin ≥ 9
g/dL
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.
5. consent form which is voluntarily signed by patients or legal representative
6. men or women , age 18
7. 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.
8. Measurable disease, according to the response Evaluation criteria in solid
tumors(RECIST), assessed using imaging techniques(CT or MRI)
Exclusion Criteria:
1. have received treatment within the last 30 days of study enrolment with a drug that
has not received approval for any indication
2. heart failure, angina pectoris or arrhythmia which is uncontrolledwith medication
within the previous 6 month .
3. serious neurological or mental disorder.
4. active infection that would compromise the patient's ability to stand the study, at
the discretion of the investigator.
5. uncontrolled diabetes.
6. 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.
7. pregnancy
8. breast feeding.
Type of Study:
Interventional
Study Design:
Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Response rate by RECIST criteria
Principal Investigator
YeulHong Kim, professor
Investigator Role:
Principal Investigator
Investigator Affiliation:
Korea University Anam Hospital
Authority:
Korea: Food and Drug Administration
Study ID:
AN0561-008
NCT ID:
NCT00436423
Start Date:
March 2006
Completion Date:
Related Keywords:
- Pancreatic Neoplasm
- Neoplasm Metastasis
- pancreatic neoplasm
- drug therapy
- gemcitabine
- TS-1
- Neoplasms
- Neoplasm Metastasis
- Pancreatic Neoplasms
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