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Clinical Trial Record

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Phase I/II Trial GOFL in Advanced Pancreatic Adenocarcinoma

2003-03

N/A

2005-08

45

Study Overview

Phase I/II Trial GOFL in Advanced Pancreatic Adenocarcinoma

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.

For each dose of GOFL chemotherapy, intravenous infusion of gemcitabine at a fixed rate of 10 mg/m2/min will be immediately followed by a 2-hour intravenous infusion of oxaliplatin and then a 48-hour intravenous infusion of 5-FU and leucovorin.The starting dose of oxaliplatin in the phase I part is 65 mg/m2, with dose increment of 10 mg/m2. Since the recommended dose for biweekly single dose oxaliplatin is 85 mg/m2, there will be no further dose escalation of oxaliplatin beyond 85 mg/m2.Patients will be entered in cohorts of three.If one out of three patients develops DLT, three additional patients will be accrued to the same dose level.9.1.3 The six patients treated at the MTD dose level will be included in the phase II part of this study if only they have measurable lesion(s) prior to chemotherapy.For the phase II part, If three or more responders are observed in the initial 21 evaluable patients, the trial will proceed to the second stage. Additional 24 patients will be accrued in the second stage of the phase II part.

  • Pancreatic Adenocarcinoma
  • DRUG: oxaliplatin
  • DRUG: gemcitabine
  • DRUG: 5-FU/LV
  • 900905

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates Results Reporting Dates Study Record Updates

2005-09-08  

N/A  

2005-09-08  

2005-09-08  

N/A  

2005-09-12  

2005-09-12  

N/A  

2005-08  

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

Primary Purpose:
Treatment

Allocation:
Non Randomized

Interventional Model:
Single Group

Masking:
None

Arms and Interventions

Participant Group/ArmIntervention/Treatment
Primary Outcome MeasuresMeasure DescriptionTime Frame
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 Outcome MeasuresMeasure DescriptionTime Frame
To evaluate clinical benefit response, overall survival of GOFL

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.

Ages Eligible for Study:
ALL

Sexes Eligible for Study:
20 Years

Accepts Healthy Volunteers:

    Inclusion Criteria:

  • 5.1.1 Patients must have metastatic or unresectable adenocarcinoma of the pancreas. The diagnosis of pancreatic adenocarcinoma must be confirmed by histopathology or cytology.

    • 5.1.2 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.
    5.1.3 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.
    5.1.5 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.
    5.1.9 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.
    5.1.10 Patients who have biliary obstruction and have undergone adequate drainage procedures before enrollment are eligible.
    5.1.11 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.
    5.1.13 All patients must be informed of the investigational nature of this study and must sign and give written informed consent.
    Exclusion Criteria:5.2.1 Patients who have central nervous system metastasis 5.2.2 Patients who have active infection 5.2.3 Pregnant or breast-nursing women 5.2.4 Patients who have active cardiac disease or history of ischemic heart disease 5.2.5 Patients who have peripheral neuropathy > Grade I of any etiology 5.2.6 Patients who have serious concomitant systemic disorders incompatible with the study (at the discretion of the investigator) 5.2.7 Patients who have other prior or concurrent malignancy except for adequately treated in situ carcinoma of cervix or adequately treated basal cell carcinoma of skin 5.2.8 Patients who are under biologic treatment for their malignancy
    -

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

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

Publications

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

No publications available

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The information and services provided by the National Pancreatic Cancer Foundation are for informational purposes only. The information and services are not intended to be substitutes for professional medical advice, diagnosis or treatment. The National Pancreatic Cancer Foundation does not recommend nor endorse any specific physicians, products or treatments even though they may be mentioned on this site.

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