Clinical trial · Interventional
Phase I/II Study of TPF as First-line Chemotherapy in Patients With Metastatic Esophageal Cancer.
Phase I/II Study of Docetaxel, Cisplatin and 5-fluorouracil(TPF) as 1st-line Chemotherapy in Patients With Metastatic Esophageal Cancer.
NCT00209690CI-TRIAL-00003475completedPhase 1 / Phase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Esophageal Cancer | Malignant Esophageal Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| 5-FU | Drug | Fluorouracil | ALIAS |
| Briplatin | Drug | Cisplatin | ALIAS |
| Taxotere | Drug | Docetaxel | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- 1
- interventionNames
- Drug: Taxotere
- Drug: 5-FU
- Drug: Briplatin
Primary outcomes (1)
- 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.
- timeFrame
- one year
Secondary outcomes (1)
- measure
- Determine the MST(Median Survival Time) and PFS(Progression Free Survival) in Phase II setting.
- timeFrame
- one year
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 20 Years
- Maximum age
- 75 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.