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Phase I/II Study of Docetaxel, Cisplatin and 5-fluorouracil(TPF) as 1st-line Chemotherapy in Patients With Metastatic Esophageal Cancer.

Phase 1/Phase 2
20 Years
75 Years
Not Enrolling
Esophageal Cancer

Thank you

Trial Information

Phase I/II Study of Docetaxel, Cisplatin and 5-fluorouracil(TPF) as 1st-line Chemotherapy in Patients With Metastatic Esophageal Cancer.

Patients with untreated measurable metastatic esophageal cancer were included in this trial.
Patients received this combination chemotherapy repeated every 28 days until progression
disease. Starting dose (dose level 1) were docetaxel 50 mg/m2 on day 1, fixed dose
intravenously cisplatin (15 mg/m2/day) and continuous infusion 5-FU (800 mg/m2/day) on day
1-4. DLT was defined as follows (according to NCI-CTC version 2.0); Grade 4 neutropenia
lasting for more than 4days, Grade 4 anemia and thrombocytopenia, Grade 3 neutropenia
accompanied fever (>38℃) , and Grade 3 non-hematological toxicity (except for nausea,
appetite loss , general fatigue). Maximal Tolerated Dose (MTD) is determined when the
incidence of critical toxicity exceeds 50% at a certain dose level. Response rate will be
calculated according to RECIST criteria.

Inclusion Criteria:

- Histologically confirmed metastatic or recurrent esophageal tumors with no previous
treatment for advanced disease.(Except for small cell carcinoma)

- At least one measurable lesion according to the RECIST criteria. Minimum indicator
lesion size: > 10 mm measured by spiral CT or >20mm measured by conventional
techniques(Except for Phase I setting).

- Patients aged between 20 and 75 years, inclusive, at the time of acquisition of
informed consent

- Patients with performance status(ECOG) 0 to 2

- Abnormal hematologic values (WBC ≥ 3.0 x 109/L, Hemoglobin ≥ 9.5g/dl, platelet count
≥ 100 x 109/L)

- Creatinine clearance ≥ 60 ml/min, Serum cleatinine ≤ 1.5mg/dl

- Serum bilirubin ≤ 1.5mg/dl. ALT, AST ≤ 2.5 x upper normal limit (or ≤ 3 x upper
normal limit in the case of liver metastases)

- Patients who have not received cancer therapy (radiotherapy, chemotherapy or

- Life expectancy ≥ 3 months

- Patients who have given written informed consent to participate in this study

Exclusion Criteria:

- Patients with active multiple cancers; or even if the multiple cancers are
metachronous, have a disease-free period of less than 5 years (but excluding cancer
in situ and skin cancer) (Except for Phase I setting)

- Serious, uncontrolled, concurrent infection(s) or illness(es)

- Patients with no serious concurrent complications (such as heart disease, Intestinal

- Patients with brain metastasis

- Patients receiving continuous administration of steroids

- Patients who have experienced serious drug allergy in the past

- Patients with retention of body fluid(pleural effusion, ascites, pericardial
effusion) necessitating treatment

- Patients who are pregnant and lactating or hope to become pregnant during the study

- Patients with prior Taxan treatment (Paclitaxel, Docetaxel)

- Patients with edema ≥ grade 2

- Others, patients judged by the investigator or subinvestigator to be inappropriate as

Type of Study:


Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Determine the DLT(Dose Limiting Toxicity) and MTD(Maximum Tolerated Dose) in Phase I setting. Determine the clinical response rate with Recommended dose in Phase II setting.

Outcome Time Frame:

one year

Safety Issue:


Principal Investigator

Masahiro Asaka, MD, PhD

Investigator Role:

Study Chair

Investigator Affiliation:

Hokkaido Gastrointestinal Cancer Study Group


Japan: Ministry of Health, Labor and Welfare

Study ID:




Start Date:

October 2003

Completion Date:

April 2010

Related Keywords:

  • Esophageal Cancer
  • Esophageal Diseases
  • Esophageal Neoplasms