Metronomic Chemotherapy in Advanced Gastric Cancer

Metastatic Gastric Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02855788
• Other study ID #: KY2016-206
• Status: Recruiting
• Phase: Phase 2
• First received: August 2, 2016
• Last updated: August 2, 2016
• Start date: May 2015
• Est. completion date: October 2018

Study information

• Verified date: August 2016
• Source: Huashan Hospital
• Contact: Nick N Chen, M.D., Ph.D.
• Phone: 206-588-1722
• Email: nicknchenmd[@]gmail.com
• Is FDA regulated: No
• Health authority: China: Shanghai Municipal Commission of Health and Family Planning
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: October 2018
• Est. primary completion date: July 2018
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

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

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Locally Advanced Gastric Cancer
• Metastatic Gastric Cancer
• Stomach Neoplasms

Intervention

Drug:
• Paclitaxel 60mg/m2, Oxaliplatin 50mg/m2, Leucovorin 20mg/m2, and 5-FU 425mg/m2 IV weekly
metronomic chemotherapy

Locations

Country	Name	City	State
China	Huashan Hospital	Shanghai	Shanghai
United States	Seattle Integrative Cancer Center	Seattle	Washington

Sponsors (2)

Lead Sponsor	Collaborator
Huashan Hospital	Seattle Integrative Cancer Center

Countries where clinical trial is conducted

United States,  China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	response rate	based on Recist 1.1	3 months	No
Secondary	adverse events	based on NCI-CTC v.2	2 years	Yes
Secondary	progression free survival	median	2 years	No
Secondary	overall survival	median	2 years	No