Clinical trial NCT02855788: 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
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Metastatic Gastric Cancer
Locally Advanced Gastric Cancer
Keywords: gastric cancer
gastroesophageal cancer
metastatic
advanced
Lead sponsor: Huashan Hospital
Sponsor class: OTHER
Collaborators: name: Seattle Integrative Cancer Center
First posted: 2016-08-04
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: response rate
timeFrame: 3 months
Secondary outcomes:
measure: adverse events
timeFrame: 2 years
measure: progression free survival
timeFrame: 2 years
measure: overall survival
timeFrame: 2 years
Other outcomes:
Locations:
city: Seattle
country: United States
facility: Seattle Integrative Cancer Center
state: Washington
city: Shanghai
country: China
facility: Huashan Hospital
state: Shanghai
Study officials:
affiliation: Huashan Hospital
name: Jie Liu, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Seattle Integrative Cancer Center
name: Nick N Chen, M.D., Ph.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Huashan Hospital
name: Jun Zhang, M.D.
role: STUDY_DIRECTOR
affiliation: Huashan Hospital
name: Zhongguang Luo, M.D.
role: STUDY_DIRECTOR
References: