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Phase I/II Trial GOFL in Advanced Pancreatic Adenocarcinoma

NCT00154791 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 45

Last updated 2005-09-12

No results posted yet for this study

Summary

We plan to conduct a phase I/II clinical trial using biweekly gemcitabine, oxaliplatin, and 48-hour infusion of high dose 5-FU/leucovorin to treat patients with advanced pancreatic adenocarcinoma. In the phase I part, the maximum tolerable dose of oxaliplatin in combination with biweekly gemcitabine 800 mg/m2 and 48-hour infusion of 5-FU 3000 mg/m2 and leucovorin 300 mg/m2 will be determined. In the phase II part, the efficacy and safety of the biweekly chemotherapy with GOFL will be evaluated.

Conditions

  • Pancreatic Adenocarcinoma

Interventions

DRUG

oxaliplatin

DRUG

gemcitabine

DRUG

5-FU/LV

Sponsors & Collaborators

  • National Health Research Institutes, Taiwan

    collaborator OTHER

  • National Taiwan University Hospital

    lead OTHER

Principal Investigators

  • Li-Tzong Chen, M.D.Ph.D · National Health Research Institutes, Division of Cancer Research

  • Hui-Ju Ch'ang, M.D. · National Taiwan University Hospital

  • Chih-Hung, Hsu, M.D. · National Taiwan University Hospital

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
20 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2003-03-31
Completion
2005-08-31

Countries

  • Taiwan

Study Locations

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Entities

Drugs

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 NCT00154791 on ClinicalTrials.gov