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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
History of Changes

July 6, 2011
August 11, 2011
August 2011
February 2012   (final data collection date for primary outcome measure)
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.
Same as current
Complete list of historical versions of study NCT01415713 on ClinicalTrials.gov Archive Site
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.
Same as current
Not Provided
Not Provided
 
The Study of Metastatic Pancreatic Adenocarcinoma
Phase I/II Trial of Biweekly S-1, Leucovorin, Oxaliplatin and Gemcitabine (SLOG) in Metastatic Pancreatic Adenocarcinoma

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

Secondary objectives: the dose-limiting toxicity of the regimen

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.
Interventional
Phase 1
Phase 2
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Metastatic Pancreatic Adenocarcinoma
Drug: S-1,Leucovorin,Oxaliplatin,Gemcitabine
Biweekly S-1, Leucovorin, Oxaliplatin and Gemcitabine (SLOG) in metastatic pancreatic adenocarcinoma
Other Name: G-CSF
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.

Intervention: Drug: S-1,Leucovorin,Oxaliplatin,Gemcitabine
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Enrolling by invitation
76
February 2013
February 2012   (final data collection date for primary outcome measure)

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.
Both
20 Years to 75 Years
No
Contact information is only displayed when the study is recruiting subjects
Taiwan
 
NCT01415713
T1211
Yes
National Health Research Instiutes, Taiwan, National Institute of Cancer Research
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
National Health Research Institutes, Taiwan
August 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP