NCT01964027

Brief Summary

This study is to determine the response rate and safety profile of irinotecan plus epirubicin as the second-line chemotherapy for advanced gastric cancer and fully evaluate the feasibility and effectiveness of the regime.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Oct 2013

Shorter than P25 for phase_2

Geographic Reach
1 country

1 active site

Status
unknown

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

First Submitted

Initial submission to the registry

January 19, 2012

Completed
1.7 years until next milestone

Study Start

First participant enrolled

October 1, 2013

Completed
16 days until next milestone

First Posted

Study publicly available on registry

October 17, 2013

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2014

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2014

Completed
Last Updated

October 17, 2013

Status Verified

October 1, 2013

Enrollment Period

9 months

First QC Date

January 19, 2012

Last Update Submit

October 14, 2013

Conditions

Stage IV Gastric Cancer With Metastasis

Keywords

second line chemoregimegastric cancer

Outcome Measures

Primary Outcomes (1)

  • PFS and OS

    Evaluation progression-free survival (PFS) and overall survival (OS) RECIST(Response Evaluation Criteria In Solid Tumors)1.1: 1. Complete response (CR) 2. Partial response (PR) 3. Stable disease(SD) and progression disease(PD) 4. CR + PR is efficient.

    2 years

Study Arms (1)

Irinotecan plus epirubicin

EXPERIMENTAL

Irinotecan(Camptosar)150mg /m2 d1,（intravenous infusion of 30-90 minutes) + epirubicin(Pharmorubicin) 50mg/m2 (total dose does not exceed 700mg/m2) every 21days for 1 treatment \* 6 cycles as the second line chemoregime for advanced gastric cancer

Drug: second line chemoregime for advanced gastric cancer

Interventions

second line chemoregime for advanced gastric cancerDRUG

Irinotecan(Camptosar)150mg /m2 d1,（intravenous infusion of 30-90 minutes) + epirubicin(Pharmorubicin) 50mg/m2 (total dose does not exceed 700mg/m2) every 21days for 1 treatment \* 6 cycles as the second line chemoregime for advanced gastric cancer

Also known as: irinotecan plus epirubicin
Irinotecan plus epirubicin

Eligibility Criteria

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

You may qualify if:

  • Aged between 18 to 70 years
  • The pathologically confirmed gastric adenocarcinoma and the failure of first-line chemotherapy
  • Measurable lesions outside the stomach
  • ECOG(Eastern Cooperative Oncology Group ) score between 0 to 1
  • Expected survival time of at least 3 months
  • Subjects receiving treatment for other damage caused has been restored, which it accepted the nitroso or mitomycin interval\> 6 weeks, the acceptance of other cytotoxic drugs, radiotherapy or surgery\> = 4 weeks, and the wound has completely healed. No bleeding, no nervous system transferred
  • Blood and organ function was normal

You may not qualify if:

  • Comorbid with other malignant tumors
  • Pregnant and lactating women
  • with the disease of endangering patient's safety and affecting the completion of the study
  • Patients suffering from high blood pressure by antihypertensive treatment cannot control (systolic blood pressure\> 140mmhg, diastolic blood pressure\> 90mmhg,) there is more than Class I and Class I arrhythmia coronary heart disease, with more than Class I heart dysfunction
  • Major organ failure, such as decompensated heart and lung failure, liver failure, renal failure and patients with intestinal obstruction ipate in other clinical trials of patients in the past four weeks
  • Participated in clinical trials with other drugs or using other drugs during past 4 weeks
  • Lesions which can't be measured such as pleural effusion, ascites, peritoneal cancer lesions, diffuse liver and bone metastases violation, brain metastasis

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Oncology,The First Affiliated Hospital of Anhui Medical University

Hefei, Anhui, 230032, China

Location

MeSH Terms

Conditions

Stomach Neoplasms

Interventions

IrinotecanEpirubicin

Condition Hierarchy (Ancestors)

Gastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesStomach Diseases

Intervention Hierarchy (Ancestors)

CamptothecinAlkaloidsHeterocyclic CompoundsDoxorubicinDaunorubicinAnthracyclinesNaphthacenesPolycyclic Aromatic HydrocarbonsHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsPolycyclic CompoundsAminoglycosidesGlycosidesCarbohydrates

Study Officials

  • Yueyin Pan, MD

    The First Affiliated Hospital of Anhui Medical University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Yueyin Pan, MD

CONTACT

865512922987yueyinpan@gmail.com

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

January 19, 2012

First Posted

October 17, 2013

Study Start

October 1, 2013

Primary Completion

July 1, 2014

Study Completion

December 1, 2014

Last Updated

October 17, 2013

Record last verified: 2013-10

Locations

CN(1)