Unresectable, advanced or recurrent esophageal cancer
Conditions
Interventions
Each treatment cycle is 28 days. TAS-102 will be administered twice daily for 5 days with 2 days rest for 2 weeks, repeated every 28 days. TAS-102 (35 mg/m2/dose) will be administered orally twice d
Sponsors
Kyoto University Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: A patient must meet all of the following inclusion criteria to be eligible for enrollment in this study: 1. Has definitive histologically or cytologically confirmed esophageal cancer (squamous cell carcinoma, adeno-squamous cell carcinoma, or basaloid squamous cell carcinoma) 2. Is diagnosed as noncurative. 3. Is diagnosed as resistant or intolerable to 5-FU, platinum compounds, and taxane. 4. Is >= 20 years of age. 5. Has Eastern Cooperative Group (ECOG) performance status of 0 or 1. 6. Has adequate organ function as defined by the following laboratory values: i. Absolute neutrophil count of >= 1,500/mm3. ii. Hemoglobin value of >= 8.0 g/dL. iii. Platelet count >= 75,000/mm3. iv. Total serum bilirubin of <= 1.5 mg/dL. v. Aspartate aminotransferase (AST) <= 3.0 x upper limit of normal (ULN); if liver function abnormalities are due to underlying liver metastasis, AST <= 5 x ULN. vi. Alanine aminotransferase (ALT) <= 3.0 x upper limit of normal (ULN); if liver function abnormalities are due to underlying liver metastasis, ALT <= 5 x ULN. vii. Serum creatinine of <= 1.5 mg/dL. 7. Has provided written informed consent prior to performance of any study procedure.
Exclusion criteria
Exclusion criteria: Exclude a patient from this study if any of the following conditions are observed: 1. Has high risk of fistula of the esophagus 2. Has a serious illness or medical condition(s) 3. Has had treatment with any of the following within the specified time frame prior to study drug administration: i. Major surgery within prior 4 weeks. ii. Minor surgery within prior 2 weeks. iii. Extended field radiation within prior 4 weeks or limited field radiation within prior 2 weeks. iv. Any anticancer therapy within prior 3 weeks. v. Any targeted therapies using antibodies including investigational agents received within prior 4 weeks. vi. Any investigational therapies except for investigational agents of v. within prior 4 weeks, excluding therapy with bisphosphonates and anti-RANKL antibodies. 4. Has received TAS-102. 5. Has unresolved toxicity of greater than or equal to CTCAE Grade 2 attributed to any prior therapies (excluding alopecia, dysgeusia, nail damage, and skin pigmentation of any grades, and neurotoxicity of Grade 1-2). 6. Is a pregnant or lactating female. 7. Has a desire for a child 8. Is inappropriate for entry into this study in the judgment of the Investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progression-free survival rate at 3 months | — |
Secondary
| Measure | Time frame |
|---|---|
| Progression-free survival rate at 6 months Progression-free survival Overall survival Overall response rate Disease control rate Safety and tolerability | — |
Countries
Japan
Contacts
Public ContactHiroi Kasai
Kyoto University Hospital Institute for Advancement of Clinical and Translational Science
Outcome results
None listed