NCT02558868

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
80

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Sep 2015

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2015

Completed
6 days until next milestone

First Submitted

Initial submission to the registry

September 7, 2015

Completed
17 days until next milestone

First Posted

Study publicly available on registry

September 24, 2015

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2017

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2017

Completed
Last Updated

June 21, 2018

Status Verified

June 1, 2018

Enrollment Period

2.1 years

First QC Date

September 7, 2015

Last Update Submit

June 20, 2018

Conditions

Pancreatic Neoplasms

Outcome Measures

Primary Outcomes (1)

  • Overall Survival

    1 years

Secondary Outcomes (1)

  • Progression Free Survival

    1 years

Study Arms (2)

Oxaliplatin + Irinotecan

EXPERIMENTAL

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

Drug: IrinotecanDrug: Oxaliplatin

Irinotecan

ACTIVE COMPARATOR

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

Drug: Irinotecan

Interventions

IrinotecanDRUG
IrinotecanOxaliplatin + Irinotecan
OxaliplatinDRUG
Oxaliplatin + Irinotecan

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

First affiliated hospital, Zhejiang University

Hangzhou, Zhejiang, 310006, China

Location

Related Publications (1)

  • 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.

    PMID: 24982456RESULT

MeSH Terms

Conditions

Pancreatic Neoplasms

Interventions

IrinotecanOxaliplatin

Condition Hierarchy (Ancestors)

Digestive System NeoplasmsNeoplasms by SiteNeoplasmsEndocrine Gland NeoplasmsDigestive System DiseasesPancreatic DiseasesEndocrine System Diseases

Intervention Hierarchy (Ancestors)

CamptothecinAlkaloidsHeterocyclic CompoundsCoordination ComplexesOrganic Chemicals

Study Officials

  • Weijia Fang, Doctor

    First Affiliated Hospital,Zhejiang University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director

Study Record Dates

First Submitted

September 7, 2015

First Posted

September 24, 2015

Study Start

September 1, 2015

Primary Completion

September 30, 2017

Study Completion

December 31, 2017

Last Updated

June 21, 2018

Record last verified: 2018-06

Locations

CN(1)