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The Study of Metastatic Pancreatic Adenocarcinoma

Primary Purpose

Metastatic Pancreatic Adenocarcinoma

Status
Completed
Phase
Phase 1
Locations
Taiwan
Study Type
Interventional
Intervention
S-1,Leucovorin,Oxaliplatin,Gemcitabine
Sponsored by
National Health Research Institutes, Taiwan
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Metastatic Pancreatic Adenocarcinoma focused on measuring enroll the 80 patients in this trial

Eligibility Criteria

20 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

  • National Taiwan University Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Statin dose titration

Arm 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.

Outcomes

Primary Outcome Measures

to determine the following items in patients with metastatic pancreatic adenocarcinoma receiving SLOG
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 Outcome Measures

to evaluate the following items in patients with metastatic pancreatic adenocarcinoma receiving SLOG treatment,
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.

Full Information

First Posted
July 6, 2011
Last Updated
May 3, 2016
Sponsor
National Health Research Institutes, Taiwan
Collaborators
National Taiwan University Hospital, National Cheng-Kung University Hospital, Chang Gung Memorial Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT01415713
Brief Title
The Study of Metastatic Pancreatic Adenocarcinoma
Official Title
Phase I/II Trial of Biweekly S-1, Leucovorin, Oxaliplatin and Gemcitabine (SLOG) in Metastatic Pancreatic Adenocarcinoma
Study Type
Interventional

2. Study Status

Record Verification Date
June 2011
Overall Recruitment Status
Completed
Study Start Date
March 2012 (undefined)
Primary Completion Date
April 2016 (Actual)
Study Completion Date
April 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
National Health Research Institutes, Taiwan
Collaborators
National Taiwan University Hospital, National Cheng-Kung University Hospital, Chang Gung Memorial Hospital

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Metastatic Pancreatic Adenocarcinoma
Keywords
enroll the 80 patients in this trial

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
73 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Statin dose titration
Arm Type
Experimental
Arm 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.
Intervention Type
Drug
Intervention Name(s)
S-1,Leucovorin,Oxaliplatin,Gemcitabine
Other Intervention Name(s)
G-CSF
Intervention Description
Biweekly S-1, Leucovorin, Oxaliplatin and Gemcitabine (SLOG) in metastatic pancreatic adenocarcinoma
Primary Outcome Measure Information:
Title
to determine the following items in patients with metastatic pancreatic adenocarcinoma receiving SLOG
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.
Time Frame
one year
Secondary Outcome Measure Information:
Title
to evaluate the following items in patients with metastatic pancreatic adenocarcinoma receiving SLOG treatment,
Description
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.
Time Frame
one year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion criteria: Patients must have cyto-/histologically confirmed, recurrent or metastatic adenocarcinoma of the pancreas (mPAC). Patients must have no history of prior chemotherapy. Patients with prior radiotherapy. Patients' baseline ECOG performance status must be 2. Patients' life expectancy must be 12 weeks or greater. Patients' age must be 20 and 75. Patients must have adequate bone marrow function. Patients must have adequate liver and renal function. All patients must be sign and give written informed consent. Exclusion criteria: Patients who have major abdominal surgery, radiotherapy. Patients with central nervous system metastasis. Patients with active infection. Pregnant or breast-nursing women. Patients with active cardiopulmonary disease. Patients who have peripheral neuropathy > Grade I. Patients who have serious concomitant systemic disorders. Patients who have other prior or concurrent malignancy. Patients who are under biologic treatment for their malignancy.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Li-Tzong Chen, Ph.D.
Organizational Affiliation
National Institute of Cancer Research
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Kelvin Kun-Chih Tsai, Ph.D.
Organizational Affiliation
National Institute of Cancer Research
Official's Role
Principal Investigator
Facility Information:
Facility Name
National Taiwan University Hospital
City
Taipei
Country
Taiwan

12. IPD Sharing Statement

Plan to Share IPD
Undecided
Citations:
PubMed Identifier
31765987
Citation
Chiang NJ, Tsai KK, Hsiao CF, Yang SH, Hsiao HH, Shen WC, Hsu C, Lin YL, Chen JS, Shan YS, Chen LT. A multicenter, phase I/II trial of biweekly S-1, leucovorin, oxaliplatin and gemcitabine in metastatic pancreatic adenocarcinoma-TCOG T1211 study. Eur J Cancer. 2020 Jan;124:123-130. doi: 10.1016/j.ejca.2019.10.023. Epub 2019 Nov 22.
Results Reference
derived

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The Study of Metastatic Pancreatic Adenocarcinoma

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