A Phase Ⅱ Study of Gemcitabine Combination With TS-1 in Patient With Advanced or Recurred Pancreatic Cancer

• Status: Completed
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Korea University Anam Hospital
• Collaborators: Konkuk University Hospital; Korea University; Korea University Guro Hospital; Seoul Municipal Boramae Hospital; Seoul National University Bundang Hospital; Seoul National University Hospital
• Treatments: Gemcitabine

Criteria

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 followingAbsolute neutrophil count(ANC) ≥ 1.5 � 109/L Platelets ≥ 100 � 109/L Hemoglobin ≥ 9 g/dL 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.

Creatinine < 1.5 X ULT

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.