Metastatic Pancreatic Adenocarcinoma
Conditions
Keywords
enroll the 80 patients in this trial
Brief summary
Phase I part, Primary objective: the maximum tolerated dose of S-1 in the SLOG regimen Secondary objectives: the dose-limiting toxicity of the regimen Phase II part, Primary objective: Overall tumor response rate (by RECIST criteria) Secondary objectives: Disease control rate (Objective response rate (ORR) + stable disease ≧ 16 weeks), Time to tumor progression, Progression-free survival, Overall survival ,Safety profile, Biomarker study
Detailed description
Phase I: 2\ 24 patients Phase II: Considering a design with p0 = 0.25 and p1 = 0.40 for which error is 0.10 and errors is 0.20, these constraints can be met with a two-stage Simon's design of 25 patients in the first stage and 27 patients in the second stage.
Interventions
DRUGS-1,Leucovorin,Oxaliplatin,Gemcitabine
Biweekly S-1, Leucovorin, Oxaliplatin and Gemcitabine (SLOG) in metastatic pancreatic adenocarcinoma
Sponsors
National Taiwan University Hospital
National Cheng-Kung University Hospital
Chang Gung Memorial Hospital
National Health Research Institutes, Taiwan
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
20 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
1. Patients must have cyto-/histologically confirmed, recurrent or metastatic adenocarcinoma of the pancreas (mPAC). 2. Patients must have no history of prior chemotherapy. 3. Patients with prior radiotherapy. 4. Patients' baseline ECOG performance status must be 2. 5. Patients' life expectancy must be 12 weeks or greater. 6. Patients' age must be 20 and 75. 7. Patients must have adequate bone marrow function. 8. Patients must have adequate liver and renal function. 9. All patients must be sign and give written informed consent.
Exclusion criteria
1. Patients who have major abdominal surgery, radiotherapy. 2. Patients with central nervous system metastasis. 3. Patients with active infection. 4. Pregnant or breast-nursing women. 5. Patients with active cardiopulmonary disease. 6. Patients who have peripheral neuropathy \> Grade I. 7. Patients who have serious concomitant systemic disorders. 8. Patients who have other prior or concurrent malignancy. 9. Patients who are under biologic treatment for their malignancy.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| to determine the following items in patients with metastatic pancreatic adenocarcinoma receiving SLOG | one year | Patients will be entered in cohorts of three. In any dose level of S-1, if none develops DLT as listed after the first two doses of SLOG chemotherapy, another cohort of 3 patients will be accrued to the next dose level. If at any time two or more patients develop DLT at the same dose level, the dose escalation will be terminated, and the prior dosage level will be considered the MTD. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| to evaluate the following items in patients with metastatic pancreatic adenocarcinoma receiving SLOG treatment, | one year | 9.2.1 Simon's optimal two-stage design will be used to determine the target patient number for the phase II part of this study. Using the approach, we test a null hypothesis that the true-response probability is less than an uninteresting level (p0) of 25% against the alternative hypothesis that the true response probability is at least as great as a target level (p1) of 40%. Response probabilities less than 25% will be considered inactive while response probabilities greater than 40% will be called highly effective. |
Countries
Taiwan
Outcome results
None listed