NCT00154791

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
45

participants targeted

Target at P50-P75 for phase_1

Timeline
Completed

Started Mar 2003

Typical duration for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2003

Completed
2.4 years until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2005

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

September 8, 2005

Completed
4 days until next milestone

First Posted

Study publicly available on registry

September 12, 2005

Completed
Last Updated

September 12, 2005

Status Verified

August 1, 2005

First QC Date

September 8, 2005

Last Update Submit

September 8, 2005

Conditions

Pancreatic Adenocarcinoma

Keywords

Pancreatic adenocarcinomaOxaliplatinGemcitabine5-FU

Outcome Measures

Primary Outcomes (1)

  • Primary objective: to evaluate the maximum tolerated dose of oxaliplatin in phase I part and to evaluate the objective tumor response rate of GOFL in phase II part

Secondary Outcomes (1)

  • To evaluate clinical benefit response, overall survival of GOFL

Interventions

oxaliplatinDRUG
gemcitabineDRUG
5-FU/LVDRUG

Eligibility Criteria

Age20 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients must have metastatic or unresectable adenocarcinoma of the pancreas. The diagnosis of pancreatic adenocarcinoma must be confirmed by histopathology or cytology.
  • For the phase I part of this trial, patients who have disease measurable or evaluable on x-ray, CAT scan, or physical examination are eligible. For the phase II part of this trial, only patients who have disease measurable on x-ray, CAT scan, or physical examination are eligible.
  • Patients must have no history of prior chemotherapy. 5.1.4 Patients with prior radiotherapy are eligible if the irradiated area is not the only source of measurable or evaluable disease.
  • Patients' baseline ECOG performance status must be £ 2. 5.1.6 Patients' life expectancy must be 12 weeks or greater. 5.1.7 Patients' age must be ³ 20 and £ 75. 5.1.8 Patients must have adequate bone marrow function, defined as WBC count ³ 3,500/ul, neutrophil count ³ 1,500/ul, and platelet count ³ 100,000/ul.
  • Patients must have adequate liver function and adequate renal function, defined as the following: serum alanine (ALT) £ 5 times upper normal limit, serum total bilirubin level £ 2.0 mg/dL, and serum creatinine £ 1.5 mg/dL.
  • Patients who have biliary obstruction and have undergone adequate drainage procedures before enrollment are eligible.
  • Patients must agree to have indwelling venous catheter implanted. 5.1.12 Women or men of reproductive potential may not participate unless they have agreed to use an effective contraceptive method.
  • All patients must be informed of the investigational nature of this study and must sign and give written informed consent.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National Taiwan Univeristy Hospital

Taipei, 100, Taiwan

Location

MeSH Terms

Interventions

OxaliplatinGemcitabine

Intervention Hierarchy (Ancestors)

Coordination ComplexesOrganic ChemicalsHeterocyclic CompoundsDeoxycytidineCytidinePyrimidine NucleosidesPyrimidinesHeterocyclic Compounds, 1-Ring

Study Officials

  • Li-Tzong Chen, M.D.Ph.D

    National Health Research Institutes, Division of Cancer Research

    STUDY CHAIR

  • Hui-Ju Ch'ang, M.D.

    National Taiwan University Hospital

    PRINCIPAL INVESTIGATOR

  • Chih-Hung, Hsu, M.D.

    National Taiwan University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

September 8, 2005

First Posted

September 12, 2005

Study Start

March 1, 2003

Study Completion

August 1, 2005

Last Updated

September 12, 2005

Record last verified: 2005-08

Locations

TW(1)