Locally Advanced or Metastatic Pancreatic Adenocarcinoma

Pancreatic Adenocarcinoma Clinical Trial

Official title:

Phase II Trial of Biweekly S-1, Leucovorin and Gemcitabine in Elderly Patients With Locally Advanced or Metastatic Pancreatic Adenocarcinoma

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03559348
• Other study ID #: T1217
• Status: Completed
• Phase: Phase 2
• Start date: April 3, 2018
• Est. completion date: April 20, 2020

Study information

• Verified date: May 2018
• Source: National Health Research Institutes, Taiwan
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 49
• Est. completion date: April 20, 2020
• Est. primary completion date: April 20, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 70 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Adenocarcinoma
• Pancreatic Adenocarcinoma

Intervention

Drug:
• chemotherapy: TS-1, Leucovorin and Gemcitabine
Gemcitabine 800 mg/m2 , on day 1 S-1 80, 100 or 120 mg/d, orally twice daily on day 1 - 7; Leucovorin 60 mg/d, orally twice daily on day 1 - 7; Every 14 days as one cycle.

Locations

Country	Name	City	State
Taiwan	China Medical University Hospital	Taichung
Taiwan	Chang-Gung Memorial Hospital	Taipei

Sponsors (6)

Lead Sponsor	Collaborator
National Health Research Institutes, Taiwan	Chang Gung Memorial Hospital, China Medical University Hospital, Kaohsiung Medical University, 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	Progression-free survival (PFS)	The progression-free survival time for elderly patients with advanced pancreatic cancer	up to 5.0 months
Secondary	Overall tumor response rate		up to 18 months