Metronomic Chemotherapy in Advanced Gastric Cancer

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

Status

UNKNOWN

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02855788

Enrollment

Registered

2016-08-04

Start date

2015-05-31

Completion date

2018-10-31

Last updated

2016-08-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Locally Advanced Gastric Cancer, Metastatic Gastric Cancer

Keywords

gastric cancer, gastroesophageal cancer, metastatic, advanced

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.

Interventions

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

metronomic chemotherapy

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 70 Years

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

Design outcomes

Primary

Measure	Time frame	Description
response rate	3 months	based on Recist 1.1

Secondary

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

Countries

China, United States

Contacts

Primary ContactNick N Chen, M.D., Ph.D.

nicknchenmd@gmail.com206-588-1722

Backup ContactJie Liu, M.D.

jieliu@fudan.edu.cn021-5288236

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026