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

NCT ID: NCT02558868

Last Updated: 2018-06-21

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 80 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-09-01
• Study Completion Date: 2017-12-31

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.

Conditions

Pancreatic Neoplasms

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Oxaliplatin + Irinotecan

Irinotecan：160 mg/m2，iv 120 min，d1 q2w oxaliplatin: 85 mg/m2，iv 120 min，d1 q2w

Group Type: EXPERIMENTAL

Irinotecan

Intervention Type: DRUG

Oxaliplatin

Intervention Type: DRUG

Irinotecan

Irinotecan：180 mg/m2，iv 120 min，d1 q2w

Group Type: ACTIVE_COMPARATOR

Irinotecan

Intervention Type: DRUG

Interventions

Irinotecan

Intervention Type: DRUG

Oxaliplatin

Intervention Type: DRUG

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.
• 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Zhejiang University

OTHER

Sponsor Role: lead

Responsible Party

Weijia Fang

Director

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Weijia Fang, Doctor

Role: PRINCIPAL_INVESTIGATOR

First Affiliated Hospital,Zhejiang University

Locations

First affiliated hospital, Zhejiang University

Hangzhou, Zhejiang, China

Countries

China

References

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.

Reference Type: RESULT

PMID: 24982456 (View on PubMed)

Other Identifiers

ZYYYMedOncoPAC02

Identifier Type: -

Identifier Source: org_study_id