NCT02855788

Brief Summary

phase II study of weekly metronomic chemotherapy using weekly Paclitaxel, Oxaliplatin, Leucovorin and 5-FU (POLF) in patients with advanced gastric cancer

Trial Health

47
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 May 2015

Typical duration for phase_2

Geographic Reach
2 countries

2 active sites

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

Study Start

First participant enrolled

May 1, 2015

Completed
1.3 years until next milestone

First Submitted

Initial submission to the registry

August 2, 2016

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 4, 2016

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2018

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2018

Completed
Last Updated

August 4, 2016

Status Verified

August 1, 2016

Enrollment Period

3.2 years

First QC Date

August 2, 2016

Last Update Submit

August 2, 2016

Conditions

Metastatic Gastric CancerLocally Advanced Gastric Cancer

Keywords

gastric cancergastroesophageal cancermetastaticadvanced

Outcome Measures

Primary Outcomes (1)

  • response rate

    based on Recist 1.1

    3 months

Secondary Outcomes (3)

  • adverse events

    2 years

  • progression free survival

    2 years

  • overall survival

    2 years

Study Arms (1)

POLF regimen

EXPERIMENTAL

Paclitaxel 60mg/m2, Oxaliplatin 50mg/m2, Leucovorin 20mg/m2, and 5-FU 425mg/m2 IV weekly

Drug: Paclitaxel 60mg/m2, Oxaliplatin 50mg/m2, Leucovorin 20mg/m2, and 5-FU 425mg/m2 IV weekly

Interventions

Paclitaxel 60mg/m2, Oxaliplatin 50mg/m2, Leucovorin 20mg/m2, and 5-FU 425mg/m2 IV weeklyDRUG

metronomic chemotherapy

Also known as: Taxol, Eloxatin
POLF regimen

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • pathologically confirmed gastric cancer AJCC stage III or IV
  • measurable disease based on CT or endoscopy exam
  • non-surgical candidates or patients who declined surgery
  • non-radiation candidates or patients who declined radiation
  • patients who are able to sign informed consent
  • patients who are 2 weeks out and recovered from surgery
  • patients who have completed radiation to relieve obstructive symptoms
  • patient who previously received Oxaliplatin and 5-FU in other MTD regimens
  • adequate marrow function: neutrophil \>1000/ul, Hgb \>10g/dl, Plt\>50,000

You may not qualify if:

  • allergic to any of the drugs involved
  • concurrent malignancies
  • severe co-morbidities of heart, lungs, kidneys and bone marrow
  • severe psychological disorder
  • severe malnutrition
  • difficult to heal or unhealed wound
  • ECOG performance status equal or over 3
  • uncontrolled complications from the malignancy
  • uncontrolled CNS metastasis
  • peripheral neuropathy grade 3 or above
  • pregnancy or breast feeding

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Seattle Integrative Cancer Center

Seattle, Washington, 98188, United States

NOT YET RECRUITING

Huashan Hospital

Shanghai, Shanghai Municipality, 200040, China

RECRUITING

MeSH Terms

Conditions

Stomach NeoplasmsNeoplasm Metastasis

Interventions

PaclitaxelOxaliplatinLeucovorinFluorouracil

Condition Hierarchy (Ancestors)

Gastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesStomach DiseasesNeoplastic ProcessesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

TaxoidsCyclodecanesCycloparaffinsHydrocarbons, AlicyclicHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsDiterpenesTerpenesCoordination ComplexesFormyltetrahydrofolatesTetrahydrofolatesFolic AcidPterinsPteridinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic CompoundsCoenzymesEnzymes and CoenzymesUracilPyrimidinonesPyrimidinesHeterocyclic Compounds, 1-Ring

Study Officials

  • Jie Liu, M.D.

    Huashan Hospital

    PRINCIPAL INVESTIGATOR

  • Nick N Chen, M.D., Ph.D.

    Seattle Integrative Cancer Center

    PRINCIPAL INVESTIGATOR

  • Jun Zhang, M.D.

    Huashan Hospital

    STUDY DIRECTOR

  • Zhongguang Luo, M.D.

    Huashan Hospital

    STUDY DIRECTOR

Central Study Contacts

Nick N Chen, M.D., Ph.D.

CONTACT

206-588-1722nicknchenmd@gmail.com

Jie Liu, M.D.

CONTACT

021-5288236jieliu@fudan.edu.cn

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
Visiting Professor

Study Record Dates

First Submitted

August 2, 2016

First Posted

August 4, 2016

Study Start

May 1, 2015

Primary Completion

July 1, 2018

Study Completion

October 1, 2018

Last Updated

August 4, 2016

Record last verified: 2016-08

Data Sharing

IPD Sharing
Will share

Locations

US(1)CN(1)