A Phase 2 interventional study of Paclitaxel 60mg/m2, Oxaliplatin 50mg/m2, Leucovorin 20mg/m2, and 5-FU 425mg/m2 IV weekly in Metastatic Gastric Cancer and Locally Advanced Gastric Cancer, sponsored by Huashan Hospital. Status unknown at 2 sites in 2 countries. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2016-08-04.
Sponsored by Huashan Hospital · Phase 2, Interventional, and Treatment
phase II study of weekly metronomic chemotherapy using weekly Paclitaxel, Oxaliplatin, Leucovorin and 5-FU (POLF) in patients with advanced gastric cancer
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.
2,914 studies on the registry are indexed under Stomach Neoplasms; 881 are open to participants now.
This study's planned enrollment of 40 is below the median of 66 across 2,143 interventional studies indexed under Stomach Neoplasms.
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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
Drug page: Paclitaxel
metronomic chemotherapy
Also known as: Taxol, Eloxatin
response rate
based on Recist 1.1
Time frame: 3 months
adverse events
based on NCI-CTC v.2
Time frame: 2 years
progression free survival
median
Time frame: 2 years
overall survival
median
Time frame: 2 years
Plan to share: Yes
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This study is status unknown, as verified in Aug 2016. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Paclitaxel