A Phase Ⅱ Study Of Gemcitabine Combination With TS-1 In Patient With Advanced Or Recurred Pancreatic Cancer

Study Overview

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

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.

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.

Pancreatic Neoplasm
Neoplasm Metastasis

DRUG: gemcitabine, TS-1

AN0561-008

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates	Results Reporting Dates	Study Record Updates
First Submitted 2007-02-16	Results First Submitted N/A	Last Update Submitted that met QC Criteria 2007-10-31
First Submitted that Met QC Criteria 2007-02-16	Results First Submitted that Met QC Criteria N/A	Last Update Posted (ESTIMATED) 2007-11-01
First Posted (ESTIMATED) 2007-02-19	Results First Posted N/A	Last Verified 2007-10

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

Primary Purpose:
Treatment

Allocation:
Non Randomized

Interventional Model:
Single Group

Masking:
None

Arms and Interventions

Participant Group/Arm	Intervention/Treatment
EXPERIMENTAL: 1 Gemcitabine with TS-1	DRUG: gemcitabine, TS-1

Participant Group/Arm

Intervention/Treatment

EXPERIMENTAL: 1

Gemcitabine with TS-1

DRUG: gemcitabine, TS-1

Primary Outcome Measures	Measure Description	Time Frame
Response rate by RECIST criteria

Secondary Outcome Measures	Measure Description	Time Frame
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

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.

Ages Eligible for Study:
ALL

Sexes Eligible for Study:
18 Years

Accepts Healthy Volunteers:

Absolute 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.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

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

PRINCIPAL_INVESTIGATOR: YeulHong Kim, professor, Korea University Anam Hospital

Publications

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

No publications available

Learn

Resources

PatientS

Caregivers

Clinical Trial Record