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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00209716
Other study ID # HGCSG0305-2
Secondary ID TPF-2
Status Completed
Phase Phase 1/Phase 2
First received September 13, 2005
Last updated May 24, 2010
Start date December 2003
Est. completion date November 2009

Study information

Verified date May 2010
Source Hokkaido Gastrointestinal Cancer Study Group
Contact n/a
Is FDA regulated No
Health authority Japan: Ministry of Health, Labor and Welfare
Study type Interventional

Clinical Trial 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 Pre-treated patients with metastatic esophageal cancer. The usefulness of the this regimen is evaluated by response rate, median survival time, and progression free survival.


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. Starting dose (dose level 1) were docetaxel 30 mg/m2 on day 1, fixed dose intravenously cisplatin (15 mg/m2/day) and continuous infusion 5-FU (800 mg/m2/day) on day 1-4. DLT was defined as follows (according to NCI-CTC version 2.0); Grade 4 neutropenia lasting for more than 4days, Grade 4 anemia and thrombocytopenia, Grade 3 neutropenia accompanied fever (>38℃) , and Grade 3 non-hematological toxicity (except for nausea, appetite loss , general fatigue). Maximal Tolerated Dose (MTD) is determined when the incidence of critical toxicity exceeds 50% at a certain dose level. Response rate will be calculated according to RECIST criteria.


Recruitment information / eligibility

Status Completed
Enrollment 30
Est. completion date November 2009
Est. primary completion date October 2009
Accepts healthy volunteers No
Gender Both
Age group 20 Years to 75 Years
Eligibility Inclusion Criteria:

- 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 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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Drug:
Taxotere
30 mg/m2, IV (in the vein) on day 1 of each 28 day cycle.
5-Fluorouracil
800 mg/m2, CIV (CIV.in the vein) on day 1~5 of each 28 day cycle.
Briplatin
15 mg/m2, IV (in the vein) on day 1~4 of each 28 day cycle.

Locations

Country Name City State
Japan · Hokkaido University Hospital (Hokkaido University Graduate School of Medicine) Sapporo Hokkaido

Sponsors (2)

Lead Sponsor Collaborator
Hokkaido Gastrointestinal Cancer Study Group Hokkaido University Hospital

Country where clinical trial is conducted

Japan, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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. 1 year Yes
Secondary Determine the clinical response rate of patients in Phase I setting. 1-year Yes
Secondary Determine the MST(Median Survival Time) and PFS(Progression Free Survival) in Phase II setting. 2-years Yes
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