NCT03585673

Docetaxel-polymeric Micelles(PM) and Oxaliplatin for Esophageal Carcinoma

A Phase II Trial of Docetaxel-polymeric Micelles(PM) Plus Oxaliplatin as a First-line Chemotherapy in Patients With Esophageal Squamous Cell Carcinoma

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 38 (estimated)
• Sponsor: Sung Yong Oh · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Esophagus Squamous Cell Carcinoma (SCC)
• Metastatic Cancer

Interventions

Type	Name	Description
DRUG	Docetaxel-PM	Docetaxel-PM 35mg/m2 intravenous over 1hour day1 and 8 every 3 weeks till progression
DRUG	Oxaliplatin	Oxaliplatin 120mg/m2 intravenous over 2 hour day 1 every 3 weeks till progression

Timeline

• Start date: 2018-06-01
• Primary completion: 2020-03-30
• Completion: 2021-03-30
• First posted: 2018-07-13
• Last updated: 2018-07-17

Locations

1 site across 1 country: South Korea