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Phase I/II Trial GOFL in Advanced Pancreatic Adenocarcinoma

Primary Purpose

Pancreatic Adenocarcinoma

Status
Completed
Phase
Phase 1
Locations
Taiwan
Study Type
Interventional
Intervention
oxaliplatin
gemcitabine
5-FU/LV
Sponsored by
National Taiwan University Hospital
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pancreatic Adenocarcinoma focused on measuring Pancreatic adenocarcinoma, Oxaliplatin, Gemcitabine, 5-FU

Eligibility Criteria

20 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept 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 -

Sites / Locations

  • National Taiwan Univeristy Hospital

Outcomes

Primary Outcome Measures

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 Measures

To evaluate clinical benefit response, overall survival of GOFL

Full Information

First Posted
September 8, 2005
Last Updated
September 8, 2005
Sponsor
National Taiwan University Hospital
Collaborators
National Health Research Institutes, Taiwan
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1. Study Identification

Unique Protocol Identification Number
NCT00154791
Brief Title
Phase I/II Trial GOFL in Advanced Pancreatic Adenocarcinoma
Official Title
Phase I/II Trial of Biweekly Gemcitabine, Oxaliplatin, and 48-Hour Infusion of High-Dose 5-FU/Leucovorin (GOFL) in Advanced Pancreatic Adenocarcinoma
Study Type
Interventional

2. Study Status

Record Verification Date
August 2005
Overall Recruitment Status
Completed
Study Start Date
March 2003 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
August 2005 (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
National Taiwan University Hospital
Collaborators
National Health Research Institutes, Taiwan

4. Oversight

5. Study Description

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.
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 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pancreatic Adenocarcinoma
Keywords
Pancreatic adenocarcinoma, Oxaliplatin, Gemcitabine, 5-FU

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
45 (false)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
oxaliplatin
Intervention Type
Drug
Intervention Name(s)
gemcitabine
Intervention Type
Drug
Intervention Name(s)
5-FU/LV
Primary Outcome Measure Information:
Title
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 Measure Information:
Title
To evaluate clinical benefit response, overall survival of GOFL

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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 -
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Li-Tzong Chen, M.D.Ph.D
Organizational Affiliation
National Health Research Institutes, Division of Cancer Research
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Hui-Ju Ch'ang, M.D.
Organizational Affiliation
National Taiwan University Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Chih-Hung, Hsu, M.D.
Organizational Affiliation
National Taiwan University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
National Taiwan Univeristy Hospital
City
Taipei
ZIP/Postal Code
100
Country
Taiwan

12. IPD Sharing Statement

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Phase I/II Trial GOFL in Advanced Pancreatic Adenocarcinoma

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