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Gemcitabine and S-1 for Locally Advanced Unresectable or Metastatic Pancreatic Cancer

NCT00429858 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 21

Last updated 2020-09-18

Study results available
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Summary

RATIONALE: Studying samples of tumor tissue and blood from patients with cancer in the laboratory may help doctors learn more about changes that may occur in DNA and identify biomarkers related to cancer. It may also help doctors predict a patient's response to treatment and help plan the best treatment.

PURPOSE: This phase II trial is studying gene expression in predicting treatment response in patients receiving gemcitabine and S-1 for locally advanced unresectable or metastatic pancreatic cancer.

Conditions

Interventions

DRUG

S-1

S-1 is given as follows: 25 mg/m2 bid on days 1-7 and 15-21 of the cycle (28 days)

DRUG

gemcitabine hydrochloride

Patients will receive gemcitabine at a dose of 1,000 mg/m2 i.v. at a fixed-dose rate (FDR) infusion of 10 mg/m2/minute (100 minutes), once a week for 3 consecutive weeks, followed by one week rest. Each 4 week period is referred to as a treatment cycle

Sponsors & Collaborators

  • Eli Lilly and Company

    collaborator INDUSTRY

  • Taiho Pharmaceutical Co., Ltd.

    collaborator INDUSTRY

  • Andrew Ko

    lead OTHER

Principal Investigators

  • Andrew Ko, MD · University of California, San Francisco

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-01-22
Primary Completion
2010-01-20
Completion
2010-01-20
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00429858 on ClinicalTrials.gov