Phase I/II trial of 2‐weekly docetaxel combined with cisplatin plus fluorouracil in metastatic esophageal cancer (JCOG0807)

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/m2 [dose level (DL)1] or 40 mg/m2 [DL2] w...

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Bibliographic Details
Published in:Cancer science 2014-09, Vol.105 (9), p.1189-1195
Main Authors: Hironaka, Shuichi, Tsubosa, Yasuhiro, Mizusawa, Junki, Kii, Takayuki, Kato, Ken, Tsushima, Takahiro, Chin, Keisho, Tomori, Akihisa, Okuno, Tatsuya, Taniki, Toshikatsu, Ura, Takashi, Matsushita, Hisayuki, Kojima, Takashi, Doki, Yuichiro, Kusaba, Hitoshi, Fujitani, Kazumasa, Taira, Koichi, Seki, Shiko, Nakamura, Tsutomu, Kitagawa, Yuko
Format: Article
Language:English
Subjects:
2‐weekly docetaxel
5-Fluorouracil
Adult
Aged
Anorexia
Antineoplastic Combined Chemotherapy Protocols - adverse effects
Antineoplastic Combined Chemotherapy Protocols - therapeutic use
Cancer therapies
Carcinoma, Squamous Cell - drug therapy
Carcinoma, Squamous Cell - mortality
Carcinoma, Squamous Cell - secondary
Chemotherapy
Cisplatin
Cisplatin - administration & dosage
Clinical trials
DCF therapy
Drug dosages
Esophageal cancer
Esophageal Neoplasms - drug therapy
Esophageal Neoplasms - mortality
Esophageal Neoplasms - pathology
Esophagus
Female
Fluorouracil - administration & dosage
Gastric cancer
Humans
Hyponatremia
Kaplan-Meier Estimate
Male
Maximum Tolerated Dose
Medical research
Metastases
Metastasis
metastatic esophageal cancer
Middle Aged
Nausea
Neutropenia
Oncology
Original
Patients
phase I/II
Pneumonitis
Studies
Taxoids - administration & dosage
Toxicity
Treatment Outcome
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Summary: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/m2 [dose level (DL)1] or 40 mg/m2 [DL2] with a 3 + 3 design in phase I, on days 1 and 15) in combination with fixed‐dose CF (80 mg/m2 cisplatin, day 1; 800 mg/m2 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 
ISSN:1347-9032
1349-7006
DOI:10.1111/cas.12486