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

NCT00436423 | Completed Phase 2

• 1 other identifier: AN0561-008
• Study Type: interventional
• Target: 38
• Locations: 1 country
• Sites: 1

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.

Conditions

Pancreatic Neoplasm; Neoplasm Metastasis

Keywords

pancreatic neoplasm; drug therapy; gemcitabine; TS-1

Outcome Measures

Primary Outcomes (1)

• Response rate by RECIST criteria

Secondary Outcomes (2)

• 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

Study Arms (1)

1

EXPERIMENTAL

Gemcitabine with TS-1

Drug: gemcitabine, TS-1

Interventions

gemcitabine, TS-1 DRUG

1

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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.

Sponsors & Collaborators

• Korea University Anam Hospital: lead
• Seoul National University Hospital: collaborator
• Seoul Municipal Boramae Hospital: collaborator
• Konkuk University Hospital: collaborator
• Korea University Ansan Hospital: collaborator
• Seoul National University Bundang Hospital: collaborator
• Korea University Guro Hospital: collaborator

Study Sites (1)

YeulHong Kim

Seoul, 136-705, South Korea

Location

MeSH Terms

Conditions

Pancreatic Neoplasms; Neoplasm Metastasis

Interventions

Gemcitabine; titanium silicide

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Endocrine Gland Neoplasms; Digestive System Diseases; Pancreatic Diseases; Endocrine System Diseases; Neoplastic Processes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Heterocyclic Compounds; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring

Study Officials

• YeulHong Kim, professor

  Korea University Anam Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: February 16, 2007
• First Posted: February 19, 2007
• Study Start: March 1, 2006
• Last Updated: November 1, 2007

Record last verified: 2007-10

Locations

KR (1)