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Metronomic Chemotherapy in Advanced Gastric Cancer

Primary Purpose

Metastatic Gastric Cancer, Locally Advanced Gastric Cancer

Status
Unknown status
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
Paclitaxel 60mg/m2, Oxaliplatin 50mg/m2, Leucovorin 20mg/m2, and 5-FU 425mg/m2 IV weekly
Sponsored by
Huashan Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Metastatic Gastric Cancer focused on measuring gastric cancer, gastroesophageal cancer, metastatic, advanced

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Seattle Integrative Cancer Center
  • Huashan HospitalRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

POLF regimen

Arm Description

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

Outcomes

Primary Outcome Measures

response rate
based on Recist 1.1

Secondary Outcome Measures

adverse events
based on NCI-CTC v.2
progression free survival
median
overall survival
median

Full Information

First Posted
August 2, 2016
Last Updated
August 2, 2016
Sponsor
Huashan Hospital
Collaborators
Seattle Integrative Cancer Center
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1. Study Identification

Unique Protocol Identification Number
NCT02855788
Brief Title
Metronomic Chemotherapy in Advanced Gastric Cancer
Official Title
Phase II Study of Metronomic Chemotherapy Using POLF Regimen in the Treatment of Advanced Gastric Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
August 2016
Overall Recruitment Status
Unknown status
Study Start Date
May 2015 (undefined)
Primary Completion Date
July 2018 (Anticipated)
Study Completion Date
October 2018 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Huashan Hospital
Collaborators
Seattle Integrative Cancer Center

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Metastatic Gastric Cancer, Locally Advanced Gastric Cancer
Keywords
gastric cancer, gastroesophageal cancer, metastatic, advanced

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
POLF regimen
Arm Type
Experimental
Arm Description
Paclitaxel 60mg/m2, Oxaliplatin 50mg/m2, Leucovorin 20mg/m2, and 5-FU 425mg/m2 IV weekly
Intervention Type
Drug
Intervention Name(s)
Paclitaxel 60mg/m2, Oxaliplatin 50mg/m2, Leucovorin 20mg/m2, and 5-FU 425mg/m2 IV weekly
Other Intervention Name(s)
Taxol, Eloxatin
Intervention Description
metronomic chemotherapy
Primary Outcome Measure Information:
Title
response rate
Description
based on Recist 1.1
Time Frame
3 months
Secondary Outcome Measure Information:
Title
adverse events
Description
based on NCI-CTC v.2
Time Frame
2 years
Title
progression free survival
Description
median
Time Frame
2 years
Title
overall survival
Description
median
Time Frame
2 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Nick N Chen, M.D., Ph.D.
Phone
206-588-1722
Email
nicknchenmd@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Jie Liu, M.D.
Phone
021-5288236
Email
jieliu@fudan.edu.cn
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jie Liu, M.D.
Organizational Affiliation
Huashan Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Nick N Chen, M.D., Ph.D.
Organizational Affiliation
Seattle Integrative Cancer Center
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Jun Zhang, M.D.
Organizational Affiliation
Huashan Hospital
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Zhongguang Luo, M.D.
Organizational Affiliation
Huashan Hospital
Official's Role
Study Director
Facility Information:
Facility Name
Seattle Integrative Cancer Center
City
Seattle
State/Province
Washington
ZIP/Postal Code
98188
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Nick N Chen, M.D., Ph.D.
Phone
206-588-1722
Email
nicknchenmd@gmail.com
First Name & Middle Initial & Last Name & Degree
Deb Ellifritt, BS
Phone
207-588-1722
Email
debe@siccwa.com
First Name & Middle Initial & Last Name & Degree
Nick N Chen, M.D., Ph.D.
Facility Name
Huashan Hospital
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200040
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Zhongguang Luo, M.D.
Phone
021-5288237
Email
luozg8@126.com
First Name & Middle Initial & Last Name & Degree
Jun Zhang, M.D.
Phone
021-5288237
Email
archsteed@163.com
First Name & Middle Initial & Last Name & Degree
Jie Liu, M.D.
First Name & Middle Initial & Last Name & Degree
Nick N Chen, M.D., Ph.D.

12. IPD Sharing Statement

Plan to Share IPD
Yes

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Metronomic Chemotherapy in Advanced Gastric Cancer

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