Status:
COMPLETED
Phase I/II Study of TPF as First-line Chemotherapy in Patients With Metastatic Esophageal Cancer.
Lead Sponsor:
Hokkaido Gastrointestinal Cancer Study Group
Collaborating Sponsors:
Hokkaido University Hospital
Conditions:
Esophageal Cancer
Eligibility:
All Genders
20-75 years
Phase:
PHASE1
PHASE2
Brief 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 (T...
Detailed Description
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 ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
October 1 2003
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
April 1 2010
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT00209690
Start Date
October 1 2003
End Date
April 1 2010
Last Update
May 26 2010
Active Locations (1)
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1
・ Hokkaido University Hospital (Hokkaido University Graduate School of Medicine / School of Medicine)
Sapporo, Hokkaido, Japan, 060-8638