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

This study has been completed.
Sponsor:
Collaborators:
Seoul National University Hospital
Seoul Municipal Boramae Hospital
Konkuk University Hospital
Korea University
Seoul National University Bundang Hospital
Korea University Guro Hospital
Information provided by:
Korea University Anam Hospital
ClinicalTrials.gov Identifier:
NCT00436423
First received: February 16, 2007
Last updated: October 31, 2007
Last verified: October 2007
  Purpose

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.


Condition Intervention Phase
Pancreatic Neoplasm
Neoplasm Metastasis
Drug: gemcitabine, TS-1
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment

Resource links provided by NLM:


Further study details as provided by Korea University Anam Hospital:

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

Enrollment: 38
Study Start Date: March 2006
Arms Assigned Interventions
Experimental: 1
Gemcitabine with TS-1
Drug: gemcitabine, TS-1

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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 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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00436423

Locations
Korea, Republic of
YeulHong Kim
Seoul, Korea, Republic of, 136-705
Sponsors and Collaborators
Korea University Anam Hospital
Seoul National University Hospital
Seoul Municipal Boramae Hospital
Konkuk University Hospital
Korea University
Seoul National University Bundang Hospital
Korea University Guro Hospital
Investigators
Principal Investigator: YeulHong Kim, professor Korea University Anam Hospital
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00436423     History of Changes
Other Study ID Numbers: AN0561-008
Study First Received: February 16, 2007
Last Updated: October 31, 2007
Health Authority: Korea: Food and Drug Administration

Keywords provided by Korea University Anam Hospital:
pancreatic neoplasm
drug therapy
gemcitabine
TS-1

Additional relevant MeSH terms:
Neoplasms
Neoplasm Metastasis
Pancreatic Neoplasms
Neoplastic Processes
Pathologic Processes
Digestive System Neoplasms
Neoplasms by Site
Endocrine Gland Neoplasms
Digestive System Diseases
Pancreatic Diseases
Endocrine System Diseases
Gemcitabine
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Antineoplastic Agents
Therapeutic Uses
Antiviral Agents
Anti-Infective Agents
Enzyme Inhibitors
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Radiation-Sensitizing Agents

ClinicalTrials.gov processed this record on September 22, 2014