Status:
COMPLETED
Phase I/II Study of Taxotere,CDDP and 5-FU(TPF) in Pre-treated Pts 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 pre-treated measurable metastatic esophageal cancer were included in this trial. Patients received this combination chemotherapy repeated every 28 days until progression disease. Startin...
Eligibility Criteria
Inclusion
- Histologically confirmed metastatic or recurrent esophageal tumors with 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 ≥ 3.5 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 received 1cycle cancer therapy (radiotherapy, chemotherapy or chemoradiotherapy) given \> 4 weeks prior to the beginning of study therapy
- 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 :
December 1 2003
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
November 1 2009
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT00209716
Start Date
December 1 2003
End Date
November 1 2009
Last Update
May 26 2010
Active Locations (1)
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1
・ Hokkaido University Hospital (Hokkaido University Graduate School of Medicine)
Sapporo, Hokkaido, Japan, 060-8638