Metronomic Chemotherapy in Advanced Gastric Cancer

August 2, 2016 updated by: Nick Chen, Huashan Hospital

Phase II Study of Metronomic Chemotherapy Using POLF Regimen in the Treatment of Advanced Gastric Cancer

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

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

About 80% of patients with advanced gastric cancer are diagnosed at an advanced stage with limited treatment options including systemic chemotherapy with or without radiation. Commonly used maximally tolerated dose (MTD) chemotherapy such as DCT, ECF, FOLFOX regimens induce responses in the range of 20 to 50% with median survival in the range of 10 to 12 months. Metronomic chemotherapy has been found to have more consistent anti-tumor effects through anti-angiogenic and immunomodulating effects. Preliminary clinical studies of weekly POLF have found very encouraging clinical activities and low overall toxicities in pancreatic cancer and gastric cancer. Here we conduct a formal clinical trial to determine the clinical efficacy and side effect profiles of this regimen in patients with advanced gastric cancer.

Study Type

Interventional

Enrollment (Anticipated)

40

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • China
    • Shanghai
      • Shanghai, Shanghai, China, 200040
        • Recruiting
        • Huashan Hospital
        • Principal Investigator:
          • Nick N Chen, M.D., Ph.D.
        • Contact:
          • Zhongguang Luo, M.D.
          • Phone Number: 021-5288237
          • Email: luozg8@126.com
        • Contact:
        • Principal Investigator:
          • Jie Liu, M.D.
  • United States
    • Washington
      • Seattle, Washington, United States, 98188
        • Not yet recruiting
        • Seattle Integrative Cancer Center
        • Contact:
        • Contact:
        • Principal Investigator:
          • Nick N Chen, M.D., Ph.D.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

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

Exclusion Criteria:

  1. allergic to any of the drugs involved
  2. concurrent malignancies
  3. severe co-morbidities of heart, lungs, kidneys and bone marrow
  4. severe psychological disorder
  5. severe malnutrition
  6. difficult to heal or unhealed wound
  7. ECOG performance status equal or over 3
  8. uncontrolled complications from the malignancy
  9. uncontrolled CNS metastasis
  10. peripheral neuropathy grade 3 or above
  11. pregnancy or breast feeding

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: POLF regimen
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
metronomic chemotherapy
Other Names:
  • Taxol, Eloxatin

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
response rate
Time Frame: 3 months
based on Recist 1.1
3 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
adverse events
Time Frame: 2 years
based on NCI-CTC v.2
2 years
progression free survival
Time Frame: 2 years
median
2 years
overall survival
Time Frame: 2 years
median
2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Huashan Hospital

Collaborators

Seattle Integrative Cancer Center

Investigators

  • Principal Investigator: Jie Liu, M.D., Huashan Hospital
  • Principal Investigator: Nick N Chen, M.D., Ph.D., Seattle Integrative Cancer Center
  • Study Director: Jun Zhang, M.D., Huashan Hospital
  • Study Director: Zhongguang Luo, M.D., Huashan Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2015

Primary Completion (Anticipated)

July 1, 2018

Study Completion (Anticipated)

October 1, 2018

Study Registration Dates

First Submitted

August 2, 2016

First Submitted That Met QC Criteria

August 2, 2016

First Posted (Estimate)

August 4, 2016

Study Record Updates

Last Update Posted (Estimate)

August 4, 2016

Last Update Submitted That Met QC Criteria

August 2, 2016

Last Verified

August 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • KY2016-206

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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