The Study of Metastatic Pancreatic Adenocarcinoma

Metastatic Pancreatic Adenocarcinoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01415713
• Other study ID #: T1211
• Status: Completed
• Phase: Phase 1/Phase 2
• First received: July 6, 2011
• Last updated: May 3, 2016
• Start date: March 2012
• Est. completion date: April 2016

Study information

• Verified date: June 2011
• Source: National Health Research Institutes, Taiwan
• Contact: n/a
• Is FDA regulated: No
• Health authority: Taiwan: Department of Health
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 73
• Est. completion date: April 2016
• Est. primary completion date: April 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years to 75 Years

Eligibility

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.

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Adenocarcinoma
• Metastatic Pancreatic Adenocarcinoma

Intervention

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

Locations

Country	Name	City	State
Taiwan	National Taiwan University Hospital	Taipei

Sponsors (4)

Lead Sponsor	Collaborator
National Health Research Institutes, Taiwan	Chang Gung Memorial Hospital, National Cheng-Kung University Hospital, National Taiwan University Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	one year	Yes
Secondary	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.	one year	Yes