search
Back to results

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

Primary Purpose

Pancreatic Neoplasm, Neoplasm Metastasis

Status
Completed
Phase
Phase 2
Locations
Korea, Republic of
Study Type
Interventional
Intervention
gemcitabine, TS-1
Sponsored by
Korea University Anam Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pancreatic Neoplasm focused on measuring pancreatic neoplasm, drug therapy, gemcitabine, TS-1

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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 <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

  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.

Sites / Locations

  • YeulHong Kim

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

1

Arm Description

Gemcitabine with TS-1

Outcomes

Primary Outcome Measures

Response rate by RECIST criteria

Secondary Outcome Measures

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

Full Information

First Posted
February 16, 2007
Last Updated
October 31, 2007
Sponsor
Korea University Anam Hospital
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
search

1. Study Identification

Unique Protocol Identification Number
NCT00436423
Brief Title
A Phase Ⅱ Study of Gemcitabine Combination With TS-1 in Patient With Advanced or Recurred Pancreatic Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
October 2007
Overall Recruitment Status
Completed
Study Start Date
March 2006 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Korea University Anam Hospital
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

4. Oversight

5. Study Description

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 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pancreatic Neoplasm, Neoplasm Metastasis
Keywords
pancreatic neoplasm, drug therapy, gemcitabine, TS-1

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
38 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Description
Gemcitabine with TS-1
Intervention Type
Drug
Intervention Name(s)
gemcitabine, TS-1
Primary Outcome Measure Information:
Title
Response rate by RECIST criteria
Secondary Outcome Measure Information:
Title
Describe quantitative and qualitative toxicity of gemcitabine with TS-1
Title
Evaluate the following efficacy measure Duration of response,Time to treatment failure,Time to documented disease progression, Overall survival

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 Criteria: 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
YeulHong Kim, professor
Organizational Affiliation
Korea University Anam Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
YeulHong Kim
City
Seoul
ZIP/Postal Code
136-705
Country
Korea, Republic of

12. IPD Sharing Statement

Learn more about this trial

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

We'll reach out to this number within 24 hrs