Docetaxel and S-1 for Advanced Esophageal Cancer

The recruitment status of this study is unknown because the information has not been verified recently.
Verified September 2012 by Hallym University Medical Center.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
Jeil Pharmaceutical Co., Ltd.
Information provided by (Responsible Party):
Hallym University Medical Center
ClinicalTrials.gov Identifier:
NCT01693432
First received: September 20, 2012
Last updated: September 22, 2012
Last verified: September 2012
  Purpose

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


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

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Hallym University Medical Center:

Primary Outcome Measures:
  • Objective response rate [ Time Frame: 1.5 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Progression free survival [ Time Frame: 1.5 years ] [ Designated as safety issue: No ]
  • Overall survival [ Time Frame: 1.5 years ] [ Designated as safety issue: No ]
  • Toxicity profiles [ Time Frame: 1.5 years ] [ Designated as safety issue: Yes ]
  • Disease control rate [ Time Frame: 1.5 years ] [ Designated as safety issue: No ]

Estimated Enrollment: 37
Study Start Date: November 2011
Estimated Study Completion Date: March 2013
Estimated Primary Completion Date: March 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: DS (docetaxel+S-1)

Treatment will be delivered as a 3-week cycle.

  1. Docetaxel 60 mg/m²IV on day 1
  2. 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.

  1. Docetaxel 60 mg/m²IV on day 1
  2. S-1 80 mg/m2/day PO on day 1-14
Other Names:
  • Taxotere
  • TS-1

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01693432

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

No publications provided

Responsible Party: Hallym University Medical Center
ClinicalTrials.gov Identifier: NCT01693432     History of Changes
Other Study ID Numbers: HMC-HO-GI-1202
Study First Received: September 20, 2012
Last Updated: September 22, 2012
Health Authority: Korea: Food and Drug Administration

Keywords provided by Hallym University Medical Center:
Esophageal neoplasms
Docetaxel
S-1

Additional relevant MeSH terms:
Esophageal Neoplasms
Neoplasms
Digestive System Diseases
Digestive System Neoplasms
Esophageal Diseases
Gastrointestinal Diseases
Gastrointestinal Neoplasms
Head and Neck Neoplasms
Neoplasms by Site
Docetaxel
Antimitotic Agents
Antineoplastic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Therapeutic Uses
Tubulin Modulators

ClinicalTrials.gov processed this record on October 22, 2014