A phase II study of gemcitabine and S-1 combination therapy for metastatic pancreatic cancer

Phase 2

• Conditions: Metastatic pancreatic cancer

• Registration Number: JPRN-C000000173
• Lead Sponsor: ational Cancer Center Hospital, Hepatobiliary and Pancreatic Oncology Division

Brief Summary

A total of 55 patients from 10 institutions were enrolled between October 2004 and July 2005. The efficacy and toxicity were analyzed in 54 patients who received at least one course of GS therapy. The median number of treatment courses was 7 (range, 1-24+). Although no complete response was seen, a partial response was achieved in 24 patients, resulting in an overall response rate of 44% (95% CI, 30.9-58.6%). Twenty-six patients (48%) had stable disease. The median progression-free survival was 5.9 months (95% CI, 4.1-6.9 months) and the median overall survival was 10.1 months (95% CI, 8.5-10.8 months) with a 1-year survival rate of 33%. The major grade 3-4 toxicities were neutropenia (80%), leucopenia (59%), thrombocytopenia (22%), anorexia (17%), rash (7%), nausea (6%) and fatigue (6%). Hematological toxicity was mostly transient and there was only one episode of infection with grade 3-4 neutropenia. No treatment-related deaths occurred during the study. In Conclusion, GS therapy produced a high response rate and good survival associated with an acceptable toxicity profile in patients with metastatic pancreatic cancer. A randomized phase III trial to confirm the efficacy of GS therapy is planned. ASCO 2007 Gastrointestinal Cancers Symposium, Orlando, General poster session, 1/20/2007 (Abst. No 148)

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2005-10-01
• Study Completion: 2006-07-01
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Complete: follow-up complete
• Sex: All
• Target Recruitment: 55

Inclusion Criteria

Not provided

Exclusion Criteria

1)Pulmonary fibrosis or interstitial pneumonia, 2)Watery diarrhea, 3)Active infection (except for chronic viral hepatitis), 4)Severe complications, such as heart disease, renal failure, hepatic failure, and active gastric ulcer, 5)Marked pleural effusion or ascites, 6)Metastasis to the central nervous system, 7)Active concomitant malignancy, 8)Severe mental disorder, 9) Pregnancy or lactation

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Response rate

Secondary Outcome Measures

Name	Time	Method
Adverse event Progression free survival Survival