Metronomic Chemotherapy in Advanced Gastric Cancer

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

Detailed Description
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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.

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

Conditions
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Metastatic Gastric Cancer, Locally Advanced Gastric Cancer

Intervention / Treatment
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* Drug: Paclitaxel 60mg/m2, Oxaliplatin 50mg/m2, Leucovorin 20mg/m2, and 5-FU 425mg/m2 IV weekly


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: pathologically confirmed gastric cancer AJCC stage III or IV measurable disease based on CT or endoscopy exam non-surgical candidates or patients who declined surgery non-radiation candidates or patients who declined radiation patients who are able to sign informed consent patients who are 2 weeks out and recovered from surgery patients who have completed radiation to relieve obstructive symptoms patient who previously received Oxaliplatin and 5-FU in other MTD regimens adequate marrow function: neutrophil >1000/ul, Hgb >10g/dl, Plt>50,000 Exclusion Criteria: allergic to any of the drugs involved concurrent malignancies severe co-morbidities of heart, lungs, kidneys and bone marrow severe psychological disorder severe malnutrition difficult to heal or unhealed wound ECOG performance status equal or over 3 uncontrolled complications from the malignancy uncontrolled CNS metastasis peripheral neuropathy grade 3 or above pregnancy or breast feeding

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: POLF regimen<br>Paclitaxel 60mg/m2, Oxaliplatin 50mg/m2, Leucovorin 20mg/m2, and 5-FU 425mg/m2 IV weekly | Drug: Paclitaxel 60mg/m2, Oxaliplatin 50mg/m2, Leucovorin 20mg/m2, and 5-FU 425mg/m2 IV weekly<br>* metronomic chemotherapy<br>* Other names: Taxol, Eloxatin;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| response rate | based on Recist 1.1 | 3 months | 

Secondary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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gastric cancer, gastroesophageal cancer, metastatic, advanced