A phase 1 study of combination therapy with gemcitabine S-1 and leucovorin in patients with pancreatic cancer

Phase 1

• Conditions: Pancreatic cancer

• Registration Number: JPRN-UMIN000007556
• Lead Sponsor: The University of Tokyo, Department of Gastroenterology

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2012-03-23
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Complete: follow-up complete
• Sex: All
• Target Recruitment: 18

Inclusion Criteria

Not provided

Exclusion Criteria

1) Patients with systolic blood pressure < 100mmHg 2) Patients with an active concomitant infection 3) Patients with digestive ulcer or gastrointestinal bleeding, severe heart or renal disease 4) Patients with an active pulmonary fibrosis or interstitial pneumonia 5) Patients with severe diarrhea 6) Pregnant, lactating female and patients of reproductive potential who did not use effective contraception 7) Patients with uncontrollable massive pleural effusion or massive ascites 8) Patients with an active concomitant malignancy 9) Inappropriate patients for entry on this study in the judgement of the investigator

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Dose limiting toxicity, maximum tolerated dose, recommended dose

Secondary Outcome Measures

Name	Time	Method
Response rate, disease control rate, progression free survival, overall survival, 1-year survival rate, feasibility, safety