Phase I/II Study of TPF as First-line Chemotherapy in Patients With Metastatic Esophageal Cancer.

• Status: Completed
• Trial end date: 2010-04-01
• Target enrollment: 0
• Participant gender: All

Summary

A phase I/II study is conducted to determine the maximum-tolerated dose (MTD), dose-limiting toxicity (DLT), and efficacy of a combination chemotherapy using docetaxel, cisplatin and 5-fluorouracil (TPF) in untreated patients with metastatic esophageal cancer. The usefulness of the this regimen is evaluated by response rate, median survival time, and progression free survival.

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

Details

• Lead Sponsor: Hokkaido Gastrointestinal Cancer Study Group
• Collaborator: Hokkaido University Hospital
• Treatments: Cisplatin; Docetaxel; Fluorouracil

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 immunotherapy)

• 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 pneumonia)

• 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 period

• Patients with prior Taxan treatment (Paclitaxel, Docetaxel)

• Patients with edema ≥ grade 2

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