Locally Advanced or Metastatic Pancreatic Adenocarcinoma

NCT03559348 | Completed Phase 2 DMC

• 1 other identifier: T1217
• Study Type: interventional
• Target: 49
• Locations: 1 country
• Sites: 2

Brief Summary

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

Conditions

Pancreatic Adenocarcinoma

Keywords

in Elderly Patients

Outcome Measures

Primary Outcomes (1)

• Progression-free survival (PFS)

  The progression-free survival time for elderly patients with advanced pancreatic cancer

  up to 5.0 months

Secondary Outcomes (1)

• Overall tumor response rate

  up to 18 months

Study Arms (1)

Biweekly TS-1, Leucovorin and Gemcitabine (GSL)

EXPERIMENTAL

Gemcitabine 800 mg/m2 , on day 1 S-1 80, 100 or 120 mg/d, orally twice daily on day 1 to 7 Leucovorin 60 mg/d, orally twice daily on day 1 to 7 Every 14 days as one cycle

Drug: chemotherapy: TS-1, Leucovorin and Gemcitabine

Interventions

chemotherapy: TS-1, Leucovorin and Gemcitabine DRUG

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.

Biweekly TS-1, Leucovorin and Gemcitabine (GSL)

Eligibility Criteria

• Age: 70 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• Patients must have cyto-/histologically confirmed, recurrent or metastatic adenocarcinoma of the pancreas.
• Patients have disease measurable or evaluable on x-ray, computed tomography scan, or physical examination.
• 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.
• Patients with prior radiotherapy are eligible if the irradiated area does not involve the only lesion of measurable / evaluable disease.
• Baseline ECOG performance status is 2.
• Patients have life expectancy of at least 12 weeks.
• Patients have age 70 years.
• Patients have adequate organ function.
• Patients with biliary obstruction which is adequate drained before enrollment are eligible.
• Patients agree to have an indwelling venous catheter implanted.
• Women or men of reproductive potential should agree to use an effective contraceptive method.
• All patients must be informed of the investigational nature of this study and must sign written informed consents.

You may not qualify if:

• 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.
• Patients with metastatic lesion in central nervous system.
• Patients with active infection.
• Patients with active cardiopulmonary disease or history of ischemic heart disease.
• Patients who have peripheral neuropathy \> grade I of any etiology.
• 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.
• Patients who have other prior or concurrent malignancy except for adequately treated in situ carcinoma of cervix or adequately.

Sponsors & Collaborators

• National Health Research Institutes, Taiwan: lead
• National Taiwan University Hospital: collaborator
• China Medical University Hospital: collaborator
• Kaohsiung Medical University: collaborator
• Chang Gung Memorial Hospital: collaborator
• National Cheng-Kung University Hospital: collaborator

Study Sites (2)

China Medical University Hospital

Taichung, Taiwan

Location

Chang-Gung Memorial Hospital

Taipei, Taiwan

Location

MeSH Terms

Interventions

Leucovorin; Gemcitabine

Intervention Hierarchy (Ancestors)

Formyltetrahydrofolates; Tetrahydrofolates; Folic Acid; Pterins; Pteridines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Coenzymes; Enzymes and Coenzymes; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 18, 2018
• First Posted: June 18, 2018
• Study Start: April 3, 2018
• Primary Completion: April 20, 2020
• Study Completion: April 20, 2020
• Last Updated: July 29, 2022

Record last verified: 2018-05

Locations

TW (2)