Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

The Study of Metastatic Pancreatic Adenocarcinoma

This study is enrolling participants by invitation only.
Sponsor:
Collaborators:
National Taiwan University Hospital
National Cheng-Kung University Hospital
Chang Gung Memorial Hospital
Information provided by:
National Health Research Institutes, Taiwan
ClinicalTrials.gov Identifier:
NCT01415713
First received: July 6, 2011
Last updated: August 11, 2011
Last verified: August 2011
  Purpose

Primary objective: the maximum tolerated dose of S-1 in the SLOG regimen

Secondary objectives: the dose-limiting toxicity of the regimen


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

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Phase I/II Trial of Biweekly S-1, Leucovorin, Oxaliplatin and Gemcitabine (SLOG) in Metastatic Pancreatic Adenocarcinoma

Resource links provided by NLM:


Further study details as provided by National Health Research Institutes, Taiwan:

Primary Outcome Measures:
  • to determine the following items in patients with metastatic pancreatic adenocarcinoma receiving SLOG [ Time Frame: one year ] [ Designated as safety issue: Yes ]
    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, [ Time Frame: one year ] [ Designated as safety issue: Yes ]
    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.


Estimated Enrollment: 76
Study Start Date: August 2011
Estimated Study Completion Date: February 2013
Estimated Primary Completion Date: February 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   20 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01415713

Locations
Taiwan
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
Investigators
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

No publications provided

Responsible Party: National Health Research Instiutes, Taiwan, National Institute of Cancer Research
ClinicalTrials.gov Identifier: NCT01415713     History of Changes
Other Study ID Numbers: T1211
Study First Received: July 6, 2011
Last Updated: August 11, 2011
Health Authority: Taiwan: Department of Health

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

Additional relevant MeSH terms:
Adenocarcinoma
Carcinoma
Neoplasms
Neoplasms by Histologic Type
Neoplasms, Glandular and Epithelial
Gemcitabine
Oxaliplatin
Anti-Infective Agents
Antimetabolites
Antimetabolites, Antineoplastic
Antineoplastic Agents
Antiviral Agents
Enzyme Inhibitors
Immunologic Factors
Immunosuppressive Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Radiation-Sensitizing Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on November 25, 2014