Metronomic Chemotherapy in Advanced Gastric Cancer

• Status: Unknown status
• Trial end date: 2018-10-01
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Huashan Hospital
• Collaborator: Seattle Integrative Cancer Center
• Treatments: Leucovorin; Oxaliplatin; Paclitaxel

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