Back to resultsSecond-Line Oxaliplatin and Irinotecan Versus Irinotecan Alone for Gemcitabine and S-1 Refractory Pancreatic Cancer
Primary Purpose
Pancreatic Neoplasms
Status
Completed
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
Irinotecan
Oxaliplatin
Sponsored by
About this trial
This is an interventional treatment trial for Pancreatic Neoplasms
Eligibility Criteria
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
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.
Sites / Locations
- First affiliated hospital, Zhejiang University
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Oxaliplatin + Irinotecan
Irinotecan
Arm Description
Irinotecan：160 mg/m2，iv 120 min，d1 q2w oxaliplatin: 85 mg/m2，iv 120 min，d1 q2w
Irinotecan：180 mg/m2，iv 120 min，d1 q2w
Outcomes
Primary Outcome Measures
Overall Survival
Secondary Outcome Measures
Progression Free Survival
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02558868
Brief Title
Second-Line Oxaliplatin and Irinotecan Versus Irinotecan Alone for Gemcitabine and S-1 Refractory Pancreatic Cancer
Official Title
Second-Line Oxaliplatin and Irinotecan Versus Irinotecan Alone for Advanced Pancreatic Cancer Patients Progressed After First-line Gemcitabine and S-1: A Randomized Controlled Study
Study Type
Interventional
2. Study Status
Record Verification Date
June 2018
Overall Recruitment Status
Completed
Study Start Date
September 1, 2015 (Actual)
Primary Completion Date
September 30, 2017 (Actual)
Study Completion Date
December 31, 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Zhejiang University
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pancreatic Neoplasms
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
80 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Oxaliplatin + Irinotecan
Arm Type
Experimental
Arm Description
Irinotecan：160 mg/m2，iv 120 min，d1 q2w oxaliplatin: 85 mg/m2，iv 120 min，d1 q2w
Arm Title
Irinotecan
Arm Type
Active Comparator
Arm Description
Irinotecan：180 mg/m2，iv 120 min，d1 q2w
Intervention Type
Drug
Intervention Name(s)
Irinotecan
Intervention Type
Drug
Intervention Name(s)
Oxaliplatin
Primary Outcome Measure Information:
Title
Overall Survival
Time Frame
1 years
Secondary Outcome Measure Information:
Title
Progression Free Survival
Time Frame
1 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Weijia Fang, Doctor
Organizational Affiliation
First Affiliated Hospital,Zhejiang University
Official's Role
Principal Investigator
Facility Information:
Facility Name
First affiliated hospital, Zhejiang University
City
Hangzhou
State/Province
Zhejiang
ZIP/Postal Code
310006
Country
China
12. IPD Sharing Statement
Citations:
PubMed Identifier
24982456
Citation
Oettle H, Riess H, Stieler JM, Heil G, Schwaner I, Seraphin J, Gorner M, Molle M, Greten TF, Lakner V, Bischoff S, Sinn M, Dorken B, Pelzer U. Second-line oxaliplatin, folinic acid, and fluorouracil versus folinic acid and fluorouracil alone for gemcitabine-refractory pancreatic cancer: outcomes from the CONKO-003 trial. J Clin Oncol. 2014 Aug 10;32(23):2423-9. doi: 10.1200/JCO.2013.53.6995. Epub 2014 Jun 30.
Results Reference
result
Learn more about this trial
Second-Line Oxaliplatin and Irinotecan Versus Irinotecan Alone for Gemcitabine and S-1 Refractory Pancreatic Cancer
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