Metronomic Chemotherapy in Advanced Gastric Cancer

Phase 2

• Conditions: Metastatic Gastric Cancer; Locally Advanced Gastric Cancer
• Interventions: Drug: Paclitaxel 60mg/m2, Oxaliplatin 50mg/m2, Leucovorin 20mg/m2, and 5-FU 425mg/m2 IV weekly

• Registration Number: NCT02855788
• Lead Sponsor: Huashan Hospital

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.

Study Timeline

• Study Start: 2015-05
• Status Verified: 2016-08
• Study First Submitted: 2016-08-02
• Study First Submitted QC: 2016-08-02
• Last Update Submitted: 2016-08-02
• Study First Posted: 2016-08-04
• Last Update Posted: 2016-08-04
• Primary Completion: 2018-07
• Study Completion: 2018-10

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 40

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
POLF regimen	Paclitaxel 60mg/m2, Oxaliplatin 50mg/m2, Leucovorin 20mg/m2, and 5-FU 425mg/m2 IV weekly	Paclitaxel 60mg/m2, Oxaliplatin 50mg/m2, Leucovorin 20mg/m2, and 5-FU 425mg/m2 IV weekly

Primary Outcome Measures

Name	Time	Method
response rate	3 months	based on Recist 1.1

Secondary Outcome Measures

Name	Time	Method
progression free survival	2 years	median
overall survival	2 years	median
adverse events	2 years	based on NCI-CTC v.2

Trial Locations

Locations (2)

Seattle Integrative Cancer Center; 🇺🇸 Seattle, Washington, United States

Huashan Hospital; 🇨🇳 Shanghai, Shanghai, China