Metastatic Cancer Clinical Trial
Official title:
A Phase II Trial of Docetaxel-polymeric Micelles(PM) Plus Oxaliplatin as a First-line Chemotherapy in Patients With Esophageal Squamous Cell Carcinoma
Esophageal or esophageal-gastric junction squamous cell cancer has dismal prognosis. And still no promising chemotherapeutic drugs is existed. In this study, The investigators wanted to look at the effects and safety of first line docetaxel-PM and oxaliplatin weekly administration chemotherapy for the participants with inoperable or metastatic esophageal squamous cell carcinoma.
Few results directly study the combination of docetaxel and oxaliplatin in the squamous cell
cancer of the esophagus, but some studies have shown that it is safe to In the phase II study
for the patients with gastroesophageal junction adenocarcinoma, a prior study reported the
efficacy and safety of the combination therapy of docetaxel 80mg/m2 and oxaliplatin 100mg/m2
every 3 weeks schedule. Entire response rate was 34% and median survival duration was 11.6
months. Over grades 3 anemia and neutropenia were found in 17%, respectively, and
non-hematological toxicities were mostly mild to moderate. In this study, a five-day
preventive granulocyte colony-stimulating factor (G-CSF) was used to reduce hematology
toxicity.
Meanwhile, there was the phase I/II studies of added capecitabine to docetaxel and
oxaliplatin with divided schedule d1 and d8 every 3weeks for reducing toxicities. The
subjects who participated in this study had at least one previous history of chemotherapy,
but overall response rates were 43% and median values for the entire duration of survival
were 9.8months. However, the side effects were significant, with 30 % of patients seeing
diarrhea of Grade 3 or higher and 17 % seeing infection of Grade 3 or higher (SAE) reported
at 37 %.
Looking at the reasons and background for this, the effects of docetaxel on esophageal
squamous cell cancer patients are already known, and weekly divided administration has also
demonstrated a reasonable level of effectiveness and safety. In studies conducted on gastric
and esophageal adenocarcinoma, the combination of docetaxel and oxaliplatin also showed
reasonable levels of effects and side effects.
In this study, The investigators wanted to look at the effects and safety of first line
docetaxel-PM and oxaliplatin weekly administration chemotherapy for the participants with
inoperable or metastatic esophageal squamous cell carcinoma.
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