Clinical trial NCT03559348: Locally Advanced or Metastatic Pancreatic Adenocarcinoma
Official title: Phase II Trial of Biweekly S-1, Leucovorin and Gemcitabine in Elderly Patients With Locally Advanced or Metastatic Pancreatic Adenocarcinoma
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Pancreatic Adenocarcinoma
Keywords: in Elderly Patients
Lead sponsor: National Health Research Institutes, Taiwan
Sponsor class: OTHER
Collaborators: name: National Taiwan University Hospital
name: China Medical University Hospital
name: Kaohsiung Medical University
name: Chang Gung Memorial Hospital
name: National Cheng-Kung University Hospital
First posted: 2018-06-18
Enrollment: 49
Sex: ALL
Minimum age (years): 70
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Multiple centers, uncontrolled, open-label, non-randomized single-arm study

Detailed description: To evaluate the following items in patients with metastatic pancreatic adenocarcinoma receiving GSL treatment, Primary objective: Overall tumor response rate (by RECIST criteria)

Secondary objectives:

Disease control rate (Objective response rate + stable disease ≧ 16 weeks) Time to tumor progression Progression-free survival Overall survival Clinical benefit response Quality of life Safety profile Biomarker of pancreatic cancer

Eligibility criteria: Inclusion Criteria:

1. Patients must have cyto-/histologically confirmed, recurrent or metastatic adenocarcinoma of the pancreas.
2. Patients have disease measurable or evaluable on x-ray, computed tomography scan, or physical examination.
3. Patients have no history of prior chemotherapy for metastatic pancreatic cancer. Patients who had received chemotherapy as in an adjuvant or neoadjuvant setting which was completed at least 6 months before recurrence are eligible.
4. Patients with prior radiotherapy are eligible if the irradiated area does not involve the only lesion of measurable / evaluable disease.
5. Baseline ECOG performance status is 2.
6. Patients have life expectancy of at least 12 weeks.
7. Patients have age 70 years.
8. Patients have adequate organ function.
9. Patients with biliary obstruction which is adequate drained before enrollment are eligible.
10. Patients agree to have an indwelling venous catheter implanted.
11. Women or men of reproductive potential should agree to use an effective contraceptive method.
12. All patients must be informed of the investigational nature of this study and must sign written informed consents.

Exclusion Criteria:

1. Patients who have major abdominal surgery, radiotherapy or other investigating agents within 4 weeks are not eligible. Patients who have palliative radiotherapy for bony metastasis will be eligible if the irradiated area does not involve the only lesion of measurable / evaluable disease.
2. Patients with metastatic lesion in central nervous system.
3. Patients with active infection.
4. Patients with active cardiopulmonary disease or history of ischemic heart disease.
5. Patients who have peripheral neuropathy \> grade I of any etiology.
6. Patients who have serious concomitant systemic disorders incompatible with the study, i.e. poorly controlled diabetes mellitus, auto-immune disorders, cirrhosis of the liver, and the rest will be at the discretion of in-charged investigator.
7. Patients who have other prior or concurrent malignancy except for adequately treated in situ carcinoma of cervix or adequately.

Primary outcomes:
measure: Progression-free survival (PFS)
timeFrame: up to 5.0 months
Secondary outcomes:
measure: Overall tumor response rate
timeFrame: up to 18 months
Other outcomes:
Locations:
city: Taichung
country: Taiwan
facility: China Medical University Hospital
city: Taipei
country: Taiwan
facility: Chang-Gung Memorial Hospital
Study officials:
References: