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The Study of Metastatic Pancreatic Adenocarcinoma

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01415713
Recruitment Status : Completed
First Posted : August 12, 2011
Last Update Posted : May 4, 2016
Information provided by (Responsible Party):

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

Condition or disease Intervention/treatment Phase
Metastatic Pancreatic Adenocarcinoma Drug: S-1,Leucovorin,Oxaliplatin,Gemcitabine Phase 1 Phase 2

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.

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 73 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase I/II Trial of Biweekly S-1, Leucovorin, Oxaliplatin and Gemcitabine (SLOG) in Metastatic Pancreatic Adenocarcinoma
Study Start Date : March 2012
Primary Completion Date : April 2016
Study Completion Date : April 2016

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: 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.

Drug: S-1,Leucovorin,Oxaliplatin,Gemcitabine
Biweekly S-1, Leucovorin, Oxaliplatin and Gemcitabine (SLOG) in metastatic pancreatic adenocarcinoma
Other Name: G-CSF

Outcome Measures

Primary Outcome Measures :
  1. to determine the following items in patients with metastatic pancreatic adenocarcinoma receiving SLOG [ Time Frame: 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 Outcome Measures :
  1. to evaluate the following items in patients with metastatic pancreatic adenocarcinoma receiving SLOG treatment, [ Time Frame: 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.

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts 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.
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01415713

National Taiwan University Hospital
Taipei, Taiwan
Sponsors and Collaborators
National Health Research Institutes, Taiwan
National Taiwan University Hospital
National Cheng-Kung University Hospital
Chang Gung Memorial Hospital
Study Chair: Li-Tzong Chen, Ph.D. National Institute of Cancer Research
Principal Investigator: Kelvin Kun-Chih Tsai, Ph.D. National Institute of Cancer Research
More Information

Responsible Party: National Health Research Institutes, Taiwan
ClinicalTrials.gov Identifier: NCT01415713     History of Changes
Other Study ID Numbers: T1211
First Posted: August 12, 2011    Key Record Dates
Last Update Posted: May 4, 2016
Last Verified: June 2011
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Keywords provided by National Health Research Institutes, Taiwan:
enroll the 80 patients in this trial

Additional relevant MeSH terms:
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Antimetabolites, Antineoplastic
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Antiviral Agents
Anti-Infective Agents
Enzyme Inhibitors
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs