Docetaxel and S-1 for Advanced Esophageal Cancer

Esophageal Neoplasms Clinical Trial

Official title:

A Phase II Study of Docetaxel and S-1 as First-line Chemotherapy in Patients With Advanced Esophageal Cancer

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01693432
• Other study ID #: HMC-HO-GI-1202
• Status: Recruiting
• Phase: Phase 2
• First received: September 20, 2012
• Last updated: August 22, 2017
• Start date: November 2011
• Est. completion date: June 2018

Study information

• Verified date: August 2017
• Source: Hallym University Medical Center
• Contact: Dae Young Zang, MD, PhD
• Phone: 82313803871
• Email: fhdzang[@]hallym.or.kr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 37
• Est. completion date: June 2018
• Est. primary completion date: June 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Esophageal Neoplasms

Intervention

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

Locations

Country	Name	City	State
Korea, Republic of	Hallym University Medical Center	Anyang

Sponsors (2)

Lead Sponsor	Collaborator
Hallym University Medical Center	Jeil Pharmaceutical Co., Ltd.

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Objective response rate	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.	1.5 years
Secondary	Progression free survival	Progression free survival time will be measured from the start of study treatment until documented tumor progression, or death due to any cause	1.5 years
Secondary	Overall survival	Overall survival time will be measured from the start of study treatment until death due to any cause	1.5 years
Secondary	Toxicity profiles	adverse events will be descripted and graded using NCI-CTCAE version 4.0	1.5 years
Secondary	Disease control rate	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.	1.5 years