Pancreatic AdenocarcinomaPhase 1/2NCT00154791
Phase I/II Trial GOFL in Advanced Pancreatic Adenocarcinoma
A Phase 1/2 study testing oxaliplatin, gemcitabine and 5-FU/LV in people with Pancreatic Adenocarcinoma, run by National Taiwan University Hospital at 1 site in Taiwan.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 75 years
- Conditions the study is for
- Pancreatic Adenocarcinoma
- What is being tested?
- oxaliplatin, gemcitabine and 5-FU/LV
- How many people
- 45 participants
- Where
- 1 siteTaiwan
- Study dates
- Mar 2003to Aug 2005
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- 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
- -
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read the 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.
- Conditions
- Pancreatic Adenocarcinoma
- Being tested
- oxaliplatin, gemcitabine, 5-FU/LV
- Keywords
- Pancreatic adenocarcinoma, Oxaliplatin, Gemcitabine, 5-FU
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
oxaliplatinDrug
gemcitabineDrug
5-FU/LVDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Sep 2005 (estimated)
- Study startMar 2003
- Study completionAug 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pancreatic AdenocarcinomaStudies of the same condition, open and under way.
- More trials run by National Taiwan University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 45 participants
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- National Health Research Institutes, Taiwan
- Investigators
- Li-Tzong Chen, M.D.Ph.D, Study chair, National Health Research Institutes, Division of Cancer ResearchHui-Ju Ch'ang, M.D., Principal investigator, National Taiwan University HospitalChih-Hung, Hsu, M.D., Principal investigator, National Taiwan University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00154791
- Sponsor's protocol ID
- 900905
- Status last verified
- Aug 2005
- First submitted
- 8 Sep 2005
- Last updated
- 12 Sep 2005
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Sep 2005. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00154791
- Acronym / sponsor ID
- 900905
- Conditions
- Pancreatic Adenocarcinoma
- Keywords
- Pancreatic adenocarcinoma, Oxaliplatin, Gemcitabine, 5-FU
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 45 participants
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Collaborators
- National Health Research Institutes, Taiwan
- Study start
- Mar 2003
- Study completion
- Aug 2005
- First posted
- 12 Sep 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 20 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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.
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| oxaliplatin | Drug | – |
| gemcitabine | Drug | – |
| 5-FU/LV | Drug | – |
Primary outcome
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
1 secondary outcome
To evaluate clinical benefit response, overall survival of GOFL
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Sep 2005.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Li-Tzong Chen, M.D.Ph.D study chair
National Health Research Institutes, Division of Cancer Research
Hui-Ju Ch'ang, M.D. principal investigator
National Taiwan University Hospital
Chih-Hung, Hsu, M.D. principal investigator
National Taiwan University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing oxaliplatin, gemcitabine and 5-FU/LV in people with Pancreatic Adenocarcinoma, run by National Taiwan University Hospital at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Sep 2005. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary 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. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Sep 2005.