Docetaxel and S-1 for Advanced Esophageal Cancer

Study Description

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Brief Summary:

This study will evaluate the efficacy of docetaxel and S-1 combination chemotherapy in Korean patients with esophageal cancer.

Condition or disease	Intervention/treatment	Phase
Esophageal Neoplasms	Drug: DS (docetaxel+S-1)	Phase 2

Detailed Description:

Esophageal cancer is the ninth most common cancer in male population in Korea. It was estimated that 1,864 new cases of esophageal cancer were reported and 1,434 deaths occurred in Korea in 2005.

Although half of the patients with esophageal cancer initially present with locoregional disease amenable to radical surgery or radiation-based therapy, most patients eventually develop metastatic disease with or without local recurrence.

Chemotherapy plays a major role in palliative therapy and remains to be the primary mode of treatment for the recurrent or metastatic esophageal cancer. Although various chemotherapy regimens are available, esophageal cancer carries a very poor prognosis, with a mean survival time of less than 8.1 months with current chemotherapies used singly or in combination with 5-fluorouracil (5-FU), vindesine, mitomycin, docetaxel, paclitaxel, cisplatin, irinotecan, vinorelbine, or capecitabine. The majority of the trials performed were in small numbers of patients with reported response rates from 15 to 40%.

The response was usually of short duration and there was no survival benefit with single agent chemotherapy. Combination chemotherapy has slightly improved the results in terms of duration of response (3-6 months), but still there was little improvement in overall survival. Therefore, the identification of new active agents is essential to prolong the survival.

Clinical trials of single agent docetaxel have been reported in patients with esophageal cancer and the response rate is about 18-25%.

S-1, a new biochemical modulator of 5-FU, is an oral dihydropyrimidine dehydrogenase(DPD) inhibitory fluoropyrimidine. The advantages of S-1 compared with 5-FU are greater convenience because of its oral formulation and continuous delivery, without intravenous infusion. S-1 is frequently used as a substitute for 5-FU in gastric cancer, but limited data is available for esophageal cancer.

The combination of docetaxel and S-1 is highly active and well tolerated in advanced or recurrent gastric cancer, and the synergistic antitumor activity has been fully elucidated.

Therefore, we will evaluate the efficacy of docetaxel and S-1 combination chemotherapy in Korean patients with esophageal cancer.

Study Design

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Study Type :	Interventional (Clinical Trial)
Estimated Enrollment :	37 participants
Intervention Model:	Single Group Assignment
Masking:	None (Open Label)
Primary Purpose:	Treatment
Official Title:	A Phase II Study of Docetaxel and S-1 as First-line Chemotherapy in Patients With Advanced Esophageal Cancer
Study Start Date :	November 2011
Estimated Primary Completion Date :	June 2018
Estimated Study Completion Date :	June 2018

Arms and Interventions

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Arm	Intervention/treatment
Experimental: DS (docetaxel+S-1); Treatment will be delivered as a 3-week cycle.; Docetaxel 60 mg/m²IV on day 1; S-1 80 mg/m2/day PO on day 1-14	Drug: DS (docetaxel+S-1); Treatment will be delivered as a 3-week cycle.; Docetaxel 60 mg/m²IV on day 1; S-1 80 mg/m2/day PO on day 1-14; Other Names: Taxotere; TS-1

Outcome Measures

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Primary Outcome Measures :

1. Objective response rate [ Time Frame: 1.5 years ]
   Objective response rate will be measured from the rate of complete response (disappearance of disease) and partial response (decrease at least 30% in the sum of the longest diameters of target lesions) by RECIST (response evaluation criteria in solid tumors) guidelines.

Secondary Outcome Measures :

1. Progression free survival [ Time Frame: 1.5 years ]
   Progression free survival time will be measured from the start of study treatment until documented tumor progression, or death due to any cause
2. Overall survival [ Time Frame: 1.5 years ]
   Overall survival time will be measured from the start of study treatment until death due to any cause
3. Toxicity profiles [ Time Frame: 1.5 years ]
   adverse events will be descripted and graded using NCI-CTCAE version 4.0
4. Disease control rate [ Time Frame: 1.5 years ]
   Disease control rate will be measured from the rate of complete response (disappearance of disease), partial response (decrease at least 30% in the sum of the longest diameters of target lesions), and stable disease (neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD) by RECIST (response evaluation criteria in solid tumors) guidelines.

Eligibility Criteria

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Ages Eligible for Study:	18 Years and older (Adult, Senior)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

• Pathologically confirmed squamous cell carcinoma or adenocarcinoma of esophagus.
• Unresectable locally advanced, recurrent or metastatic disease.
• Measurable or evaluable disease by RECIST criteria 1.1.
• Minimum age of 18 years.
• ECOG Performance status 0-2.
• Prior chemotherapy is not allowed.
• More than 4 weeks since completion of prior radiotherapy (measurable or evaluable lesions are outside the radiation field)
• Adequate organ functions
• Patients must sign an informed consent indicating that they are aware of the investigational nature of the study in keeping with the policy of the hospital

Exclusion Criteria:

• Other tumor type than squamous cell carcinoma and adenocarcinoma
• Previous history of chemotherapy except neoadjuvant or adjuvant chemotherapy without docetaxel and S-1
• Obvious bowel obstruction unrelieved by proper management
• Evidence of serious gastrointestinal bleeding
• Patients with CNS metastases
• Patients with active infection, severe heart disease, uncontrollable hypertension or diabetes mellitus, myocardial infarction during the preceding 6 months, pregnancy, or breast feeding
• Any previous or concurrent malignancy other than non-melanoma skin cancer or in situ cancer of uterine cervix
• Known history of cerebral or leptomeningeal metastases or neurologic disease

Contacts and Locations

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Contacts

Contact: Dae Young Zang, MD, PhD	82313803871	fhdzang@hallym.or.kr
Contact: Jin Hee Jung, RN	82313803704	jhjung23@daum.net

Locations

Korea, Republic of
Hallym University Medical Center	Recruiting
Anyang, Korea, Republic of
Contact: Dae Young Zang, MD, PhD 82313803871 fhdzang@hallym.or.kr
Contact: Jin Hee Jung, RN 82313803704 jhjung23@daum.net
Sub-Investigator: Hyeong Su Kim, MD
Sub-Investigator: Boram Han, MD

Sponsors and Collaborators

Hallym University Medical Center

Jeil Pharmaceutical Co., Ltd.

Investigators

Principal Investigator:	Dae Young Zang, MD, PhD	Hallym University Medical Center

More Information

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party:	Hallym University Medical Center
ClinicalTrials.gov Identifier:	NCT01693432 History of Changes
Other Study ID Numbers:	HMC-HO-GI-1202
First Posted:	September 26, 2012
Last Update Posted:	August 23, 2017
Last Verified:	August 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD:	Undecided

Keywords provided by Hallym University Medical Center:

Esophageal neoplasms; Docetaxel; S-1

Additional relevant MeSH terms:

Esophageal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Head and Neck Neoplasms; Digestive System Diseases; Esophageal Diseases	Gastrointestinal Diseases; Docetaxel; Antineoplastic Agents; Tubulin Modulators; Antimitotic Agents; Mitosis Modulators; Molecular Mechanisms of Pharmacological Action