Phase I/II Trial of Biweekly S-1, Leucovorin, Oxaliplatin and Gemcitabine (SLOG) in Metastatic Pancreatic Adenocarcinoma
20 Years
75 Years
Both
Metastatic Pancreatic Adenocarcinoma
Trial Information
Phase I/II Trial of Biweekly S-1, Leucovorin, Oxaliplatin and Gemcitabine (SLOG) in Metastatic Pancreatic Adenocarcinoma
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.
Inclusion Criteria
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.
Type of Study:
Interventional
Study Design:
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
to determine the following items in patients with metastatic pancreatic adenocarcinoma receiving SLOG
Outcome Description:
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.
Outcome Time Frame:
one year
Safety Issue:
Yes
Principal Investigator
Li-Tzong Chen, Ph.D.
Investigator Role:
Study Chair
Investigator Affiliation:
National Institute of Cancer Research
Authority:
Taiwan: Department of Health
Study ID:
T1211
NCT ID:
NCT01415713
Start Date:
August 2011
Completion Date:
February 2013
Related Keywords:
- Metastatic Pancreatic Adenocarcinoma
- enroll the 80 patients in this trial
- Adenocarcinoma
- Adenocarcinoma, Mucinous
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