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

Pancreatic Neoplasms Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02558868
• Other study ID #: ZYYYMedOncoPAC02
• Status: Completed
• Phase: Phase 2
• Start date: September 1, 2015
• Est. completion date: December 31, 2017

Study information

• Verified date: June 2018
• Source: Zhejiang University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: December 31, 2017
• Est. primary completion date: September 30, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Pancreatic Neoplasms

Intervention

Drug:
• Irinotecan

• Oxaliplatin

Locations

Country	Name	City	State
China	First affiliated hospital, Zhejiang University	Hangzhou	Zhejiang

Sponsors (1)

Lead Sponsor	Collaborator
Zhejiang University

Country where clinical trial is conducted

China, 

References & Publications (1)

Oettle H, Riess H, Stieler JM, Heil G, Schwaner I, Seraphin J, Görner M, Mölle M, Greten TF, Lakner V, Bischoff S, Sinn M, Dörken B, Pelzer U. Second-line oxaliplatin, folinic acid, and fluorouracil versus folinic acid and fluorouracil alone for gemcitabi — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Overall Survival		1 years
Secondary	Progression Free Survival		1 years