The Study of Metastatic Pancreatic Adenocarcinoma

National Health Research Institutes, Taiwan

Status and phase: Completed; Phase 2; Phase 1

Conditions: Metastatic Pancreatic Adenocarcinoma

Treatments: Drug: S-1,Leucovorin,Oxaliplatin,Gemcitabine

Study type: Interventional

Funder types: Other

Identifiers

NCT01415713

T1211

Details and patient eligibility

About

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

Full 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.

Enrollment: 73 patients

Sex: All

Ages: 20 to 75 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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73 participants in 1 patient group

Statin dose titration

Experimental group

Description:

SLOG regimen: S-1 20-40 mg/m2/b.i.d., day 1-7;Leucovorin 20 mg/m2/b.i.d., day 1-7;Oxaliplatin 85 mg/m2 in 250 mL of D5W,given as 2-hour intra-venous infusion, day 1;Gemcitabine 800 mg/m2 in 250 mL of normal saline, given as fixed dose-rate infusion,day 1;After the administration of gemcitabine, the infusion line should be flushed with 20 ml of normal saline and then 50 ml of 5% glucose solution before the administration of oxaliplatin; Every 14 days, as one cycle.Prophylactic G-CSF or GM-CSF will not be allowed in this study. In case of grade 4 or complication neutropenia, patients may receive G-CSF according to the regulation of National Insurance Bureru treated with appropriate antibiotics. Therapeutic G-CSF may be used at the discretion of attending physicians.

Treatment:

Drug: S-1,Leucovorin,Oxaliplatin,Gemcitabine