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Clinical Trial
. 2014 Sep;105(9):1189-95.
doi: 10.1111/cas.12486.

Phase I/II Trial of 2-weekly Docetaxel Combined With Cisplatin Plus Fluorouracil in Metastatic Esophageal Cancer (JCOG0807)

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Free PMC article
Clinical Trial

Phase I/II Trial of 2-weekly Docetaxel Combined With Cisplatin Plus Fluorouracil in Metastatic Esophageal Cancer (JCOG0807)

Shuichi Hironaka et al. Cancer Sci. .
Free PMC article

Abstract

We carried out a phase I/II trial of adding 2-weekly docetaxel to cisplatin plus fluorouracil (CF) therapy (2-weekly DCF regimen) in esophageal cancer patients to investigate its safety and antimetastatic activity. Patients received 2-weekly docetaxel (30 mg/m(2) [dose level (DL)1] or 40 mg/m(2) [DL2] with a 3 + 3 design in phase I, on days 1 and 15) in combination with fixed-dose CF (80 mg/m(2) cisplatin, day 1; 800 mg/m(2) fluorouracil, days 1-5) repeated every 4 weeks. The primary endpoint was dose-limiting toxicity (DLT) in phase I and central peer review-based response rate in phase II. At least 22 responders among 50 patients were required to satisfy the primary endpoint with a threshold of 35%. Sixty-two patients were enrolled in phase I and II. In phase I, 10 patients were enrolled with DLT of 0/3 at DL1 and 2/7 in DL2. Considering DLT and treatment compliance, the recommended phase II dose was determined as DL1. In phase II, the response rate was 62% (P < 0.0001; 95% confidence interval, 48-75%); median overall survival and progression-free survival were 11.1 and 5.8 months, respectively. Common grade 3/4 adverse events were neutropenia (25%), anemia (36%), hyponatremia (29%), anorexia (24%), and nausea (11%). No febrile neutropenia was observed. Pneumonitis caused treatment-related death in one patient. The 2-weekly DCF regimen showed promising antimetastatic activity and tolerability. A phase III study comparing this regimen with CF therapy is planned by the Japan Clinical Oncology Group. This study was registered at the UMIN Clinical Trials Registry as UMIN 000001737.

Keywords: 2-weekly docetaxel; Chemotherapy; DCF therapy; metastatic esophageal cancer; phase I/II.

Figures

Fig 1
Fig 1
Flowchart of a phase I/II trial of adding 2-weekly docetaxel to cisplatin plus fluorouracil therapy in esophageal cancer patients.
Fig 2
Fig 2
Kaplan–Meier estimates of overall survival (a) and progression-free survival (b) in a phase I/II trial of esophageal cancer patients treated with 2-weekly docetaxel added to cisplatin plus fluorouracil therapy.

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