Phase I/II study of divided-dose docetaxel, cisplatin and fluorouracil for patients with recurrent or metastatic squamous cell carcinoma of the esophagus

2016 ◽  
pp. n/a-n/a ◽  
Author(s):  
T. Ojima ◽  
M. Nakamori ◽  
M. Nakamura ◽  
M. Katsuda ◽  
K. Hayata ◽  
...  
Keyword(s):  
Squamous Cell Carcinoma ◽  
Phase I ◽  
Cell Carcinoma ◽  
Squamous Cell ◽  
Divided Dose ◽  
Carcinoma Of The Esophagus ◽  
Metastatic Squamous Cell Carcinoma

A phase I/II study of divided-dose docetaxel, cisplatin, and fluorouracil (DCF) for patients with recurrent or metastatic squamous cell carcinoma of the esophagus.

2015 ◽  
Vol 33 (3_suppl) ◽  
pp. 132-132
Author(s):  
Toshiyasu Ojima ◽  
Mikihito Nakamori ◽  
Masaki Nakamura ◽  
Makoto Iwahashi ◽  
Masahiro Katsuda ◽  
...  
Keyword(s):  
Squamous Cell Carcinoma ◽  
Phase I ◽  
Cell Carcinoma ◽  
Phase Ii ◽  
Squamous Cell ◽  
Response Rate ◽  
Carcinoma Of The Esophagus ◽  
Metastatic Squamous Cell Carcinoma ◽  
Level 3 ◽  
Grade 3

132 Background: The aim of this phase I/II study was to evaluate the efficacy and safety of the combined use of docetaxel, cisplatin (CDDP) and 5-fluorouracil (5-FU) (DCF) in patients with recurrent/metastatic squamous cell carcinoma of the esophagus (SCCE). This study adopted divided doses of docetaxel and CDDP in order to reduce the toxicities of the treatment. Methods: The dose of docetaxel was escalated using the following protocol in the phase I stage: level 1, 30; level 2, 35 and level 3, 40 mg/m2, which was intravenously infused for two hours on days 1 and 8. CDDP was administered at a dose of 12 mg/m2 infused for four hours on days 1-5. The 5-FU was administered at a dose of 600 mg/m2continuously infused from day 1 to 5. This regimen was repeated every four weeks. Results: The study subjects were nine patients (phase I) and 48 patients (phase II). The recommended dose was determined as level 3 in phase I. In the phase II stage, the overall response rate was 62.5%, with a complete response rate of 12.5%. The median progression-free survival was six months, and the median overall survival was 13 months. Grade 3/4 toxicities of leukopenia, neutropenia and febrile neutropenia occurred in 64.6, 68.8 and 14.6% of the patients, while grade 3/4 non-hematological toxicities were relatively rare. No treatment-related death was recorded. Conclusions: This modified DCF regimen can be a tolerable definitive chemotherapy for unresectable SCCE because of its high efficacy, although adequate care for severe neutropenia is needed. Clinical trial information: NCT00915850.

scholarly journals Triplet chemotherapy with docetaxel, cisplatin and S-1 for unresectable advanced squamous cell carcinoma of the esophagus: phase I/II trial results

Oncotarget ◽  
2019 ◽  
Vol 10 (8) ◽  
pp. 847-855 ◽  
Author(s):  
Toshiyasu Ojima ◽  
Masaki Nakamura ◽  
Mikihito Nakamori ◽  
Masahiro Katsuda ◽  
Keiji Hayata ◽  
...  
Keyword(s):  
Squamous Cell Carcinoma ◽  
Phase I ◽  
Cell Carcinoma ◽  
Squamous Cell ◽  
Advanced Squamous Cell Carcinoma ◽  
Carcinoma Of The Esophagus ◽  
Triplet Chemotherapy
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