Trial of Docetaxel, Cisplatin, Fluorouracil (5-FU) for Unresectable Advanced Esophageal Squamous Cell Carcinoma (ESCC)

• Status: Unknown status
• Trial end date: 2015-08-01
• Target enrollment: 0
• Participant gender: All

Summary

This phase I/II study is being conducted to determine the maximum-tolerated dose (MTD), dose-limiting toxicity (DLT), and efficacy of a combination chemotherapy using docetaxel, cisplatin and 5-fluorouracil (DCF) in unresectable advanced esophageal cancer. The usefulness of the this regimen is evaluated by RECIST, time to progression and median survival time.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Wakayama Medical University
• Treatments: Cisplatin; Docetaxel

Criteria

Inclusion Criteria:

• locally advanced or metastatic esophageal cancer precluding curative surgical resection and recurrent esophageal cancer measurable disease by CT scan

• ECOG performance status 0-1

• 20 years and older

• Patients must have clinically documented unresectable or metastatic esophageal cancer and histologic confirmation of the diagnosis with tumor

• Tissue from tumor must be available

• Patients must have measurable disease

• Patients may have received prior adjuvant chemotherapy; this must have been completed at least 1 month

• Life expectancy > 3 months

• Laboratory values as follows

• 3000/mm3 < WBC < 12000/mm3

• 1500/mm3 < granulocyte count

• 8.0 gm/dl < hemoglobin

• Platelet count > 100000/mm3

• Aspartate transaminase < 150 IU/L

• Alanine transaminase < 150 IU/L

• Creatinine < 1.5 mg/dl

• Able and willing to give valid written informed consent

Exclusion Criteria:

• Pregnancy (women of childbearing potential: refusal or inability to use effective means of contraception)

• Active or uncontrolled infection

• Prior chemotherapy or radiation therapy within 4 weeks, surgery within 3 weeks or immunotherapy within 1 week

• Clinically significant heart disease

• Patients with a history of myocardial infarction within the previous three months

• Patients with uncontrolled diabetes mellitus or hypertension

• Presence of clinically apparent central nervous system metastases

• Patients with any other severe concurrent disease, which in the judgment of the investigator, would make the patient inappropriate for entry into this study

• Decision of unsuitableness by principal investigator or physician-in-charge