Second-Line Oxaliplatin and Irinotecan Versus Irinotecan Alone for Gemcitabine and S-1 Refractory Pancreatic Cancer

Phase 2

Completed

• Conditions: Pancreatic Neoplasms
• Interventions: Drug: Irinotecan; Drug: Oxaliplatin

• Registration Number: NCT02558868
• Lead Sponsor: Zhejiang University

Brief Summary

This study is a randomized, open-label, controlled study that will compare the efficacy of oxaliplatin in combination with irinotecan to irinotecan alone as second-line treatment for patients with gemcitabine and S-1 refractory pancreatic cancer.

Detailed Description

Not available

Study Timeline

• Study Start: 2015-09-01
• Study First Submitted: 2015-09-07
• Study First Submitted QC: 2015-09-23
• Study First Posted: 2015-09-24
• Primary Completion: 2017-09-30
• Study Completion: 2017-12-31
• Status Verified: 2018-06
• Last Update Submitted: 2018-06-20
• Last Update Posted: 2018-06-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 80

Inclusion Criteria

• Patients with histologically confirmed advanced pancreatic cancer who had experienced progression during first-line gemcitabine and S-1 were eligible for enrollment on this open-label, randomized study.
• Additional inclusion criteria were age 18 years or older
• Measurable reference cancer site(s) confirmed with computed tomography (CT) or magnetic resonance imaging (MRI)
• Karnofsky performance status (KPS) of at least 70%
• -Adequate renal function, adequate hepatic function, adequate bone marrow function

Read More

Exclusion Criteria

• The presence of any severe concomitant disease that could interrupt the planned treatment; intractable pain
• Hypersensitivity to study drugs
• Serious cardiovascular disease (eg, unstable coronary artery disease or myocardial infarction within 4 weeks of study start)
• National Cancer Institute CommonToxicity Criteria grade 3 or 4 sensory or motor neuropathy
• Prior or concurrent malignancy (other than pancreatic cancer)
• Female, pregnancy or breastfeeding.

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Irinotecan	Irinotecan	Irinotecan：180 mg/m2，iv 120 min，d1 q2w
Oxaliplatin + Irinotecan	Irinotecan	Irinotecan：160 mg/m2，iv 120 min，d1 q2w oxaliplatin: 85 mg/m2，iv 120 min，d1 q2w
Oxaliplatin + Irinotecan	Oxaliplatin	Irinotecan：160 mg/m2，iv 120 min，d1 q2w oxaliplatin: 85 mg/m2，iv 120 min，d1 q2w

Primary Outcome Measures

Name	Time	Method
Overall Survival	1 years

Secondary Outcome Measures

Name	Time	Method
Progression Free Survival	1 years

Trial Locations

Locations (1)

First affiliated hospital, Zhejiang University; 🇨🇳 Hangzhou, Zhejiang, China