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Phase I/II Trial of Biweekly Gemcitabine, Oxaliplatin, and 48-Hour Infusion of High-Dose 5-FU/Leucovorin (GOFL) in Advanced Pancreatic Adenocarcinoma

Phase 1/Phase 2
20 Years
75 Years
Not Enrolling
Pancreatic Adenocarcinoma

Thank you

Trial Information

Phase I/II Trial of Biweekly Gemcitabine, Oxaliplatin, and 48-Hour Infusion of High-Dose 5-FU/Leucovorin (GOFL) in Advanced Pancreatic Adenocarcinoma

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.

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

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


Type of Study:


Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

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

Principal Investigator

Li-Tzong Chen, M.D.Ph.D

Investigator Role:

Study Chair

Investigator Affiliation:

National Health Research Institutes, Division of Cancer Research


Taiwan: Department of Health

Study ID:




Start Date:

March 2003

Completion Date:

August 2005

Related Keywords:

  • Pancreatic Adenocarcinoma
  • Pancreatic adenocarcinoma
  • Oxaliplatin
  • Gemcitabine
  • 5-FU
  • Adenocarcinoma
  • Adenocarcinoma, Mucinous