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Completed

NCT Number: NCT01415713

The Study of Metastatic Pancreatic Adenocarcinoma

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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Key information

Conditions

Metastatic Pancreatic Adenocarcinoma

Age range

20 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

National Taiwan University Hospital

Taipei, Taiwan

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

S-1,Leucovorin,Oxaliplatin,Gemcitabine

Drug

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

Other names: G-CSF

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

National Health Research Institutes, Taiwan

Other

Collaborators

  • Chang Gung Memorial Hospital
  • National Cheng-Kung University Hospital
  • National Taiwan University Hospital

Registry information

Official study title

Phase I/II Trial of Biweekly S-1, Leucovorin, Oxaliplatin and Gemcitabine (SLOG) in Metastatic Pancreatic Adenocarcinoma

Important dates

Study start
2012
Primary completion
2016
Study completion
2016
First posted
Aug 12, 2011
Registry last updated
May 4, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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