Status:
COMPLETED
The Study of Metastatic Pancreatic Adenocarcinoma
Lead Sponsor:
National Health Research Institutes, Taiwan
Collaborating Sponsors:
National Taiwan University Hospital
National Cheng-Kung University Hospital
Conditions:
Metastatic Pancreatic Adenocarcinoma
Eligibility:
All Genders
20-75 years
Phase:
PHASE1
PHASE2
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 r...
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 patie...
Eligibility Criteria
Inclusion
- 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.
Exclusion
Key Trial Info
Start Date :
March 1 2012
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2016
Estimated Enrollment :
73 Patients enrolled
Trial Details
Trial ID
NCT01415713
Start Date
March 1 2012
End Date
April 1 2016
Last Update
May 4 2016
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
National Taiwan University Hospital
Taipei, Taiwan