Status:
COMPLETED
A Phase Ⅱ Study of Gemcitabine Combination With TS-1 in Patient With Advanced or Recurred Pancreatic Cancer
Lead Sponsor:
Korea University Anam Hospital
Collaborating Sponsors:
Seoul National University Hospital
Seoul Municipal Boramae Hospital
Conditions:
Pancreatic Neoplasm
Neoplasm Metastasis
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief 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 receiv...
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 ...
Eligibility Criteria
Inclusion
- 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
- 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)
Exclusion
- 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.
Key Trial Info
Start Date :
March 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
Estimated Enrollment :
38 Patients enrolled
Trial Details
Trial ID
NCT00436423
Start Date
March 1 2006
Last Update
November 1 2007
Active Locations (1)
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1
YeulHong Kim
Seoul, South Korea, 136-705