The Study of Metastatic Pancreatic Adenocarcinoma

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1/PHASE2

Total Enrollment

73 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-03-31

Study Completion Date

2016-04-30

Brief Summary

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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

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Detailed Description

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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.

Conditions

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Metastatic Pancreatic Adenocarcinoma

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Statin dose titration

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.

Group Type EXPERIMENTAL

S-1,Leucovorin,Oxaliplatin,Gemcitabine

Intervention Type DRUG

Biweekly S-1, Leucovorin, Oxaliplatin and Gemcitabine (SLOG) in metastatic pancreatic adenocarcinoma

Interventions

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S-1,Leucovorin,Oxaliplatin,Gemcitabine

Biweekly S-1, Leucovorin, Oxaliplatin and Gemcitabine (SLOG) in metastatic pancreatic adenocarcinoma

Intervention Type DRUG

Other Intervention Names

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G-CSF

Eligibility Criteria

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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.

Minimum Eligible Age

20 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No