Status:
COMPLETED
Phase I/II Trial GOFL in Advanced Pancreatic Adenocarcinoma
Lead Sponsor:
National Taiwan University Hospital
Collaborating Sponsors:
National Health Research Institutes, Taiwan
Conditions:
Pancreatic Adenocarcinoma
Eligibility:
All Genders
20-75 years
Phase:
PHASE1
PHASE2
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 ...
Detailed Description
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 ...
Eligibility Criteria
Inclusion
- 1.1 Patients must have metastatic or unresectable adenocarcinoma of the pancreas. The diagnosis of pancreatic adenocarcinoma must be confirmed by histopathology or cytology.
- 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.
- 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.
- 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.
- 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.
- 1.10 Patients who have biliary obstruction and have undergone adequate drainage procedures before enrollment are eligible.
- 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.
- 1.13 All patients must be informed of the investigational nature of this study and must sign and give written informed consent.
Exclusion
- 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
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Key Trial Info
Start Date :
March 1 2003
Trial Type :
INTERVENTIONAL
End Date :
August 1 2005
Estimated Enrollment :
45 Patients enrolled
Trial Details
Trial ID
NCT00154791
Start Date
March 1 2003
End Date
August 1 2005
Last Update
September 12 2005
Active Locations (1)
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1
National Taiwan Univeristy Hospital
Taipei, Taiwan, 100