Overview

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