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Phase I/II Study of TPF as First-line Chemotherapy in Patients With Metastatic Esophageal Cancer.

Primary Purpose

Esophageal Cancer

Status
Completed
Phase
Phase 1
Locations
Japan
Study Type
Interventional
Intervention
Taxotere
5-FU
Briplatin
Sponsored by
Hokkaido Gastrointestinal Cancer Study Group
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Esophageal Cancer

Eligibility Criteria

20 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • ・ Hokkaido University Hospital (Hokkaido University Graduate School of Medicine / School of Medicine)

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

1

Arm Description

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Determine the MST(Median Survival Time) and PFS(Progression Free Survival) in Phase II setting.

Full Information

First Posted
September 13, 2005
Last Updated
May 24, 2010
Sponsor
Hokkaido Gastrointestinal Cancer Study Group
Collaborators
Hokkaido University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT00209690
Brief Title
Phase I/II Study of TPF as First-line Chemotherapy in Patients With Metastatic Esophageal Cancer.
Official Title
Phase I/II Study of Docetaxel, Cisplatin and 5-fluorouracil(TPF) as 1st-line Chemotherapy in Patients With Metastatic Esophageal Cancer.
Study Type
Interventional

2. Study Status

Record Verification Date
May 2010
Overall Recruitment Status
Completed
Study Start Date
October 2003 (undefined)
Primary Completion Date
December 2009 (Actual)
Study Completion Date
April 2010 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Hokkaido Gastrointestinal Cancer Study Group
Collaborators
Hokkaido University Hospital

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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 (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.
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 dose (dose level 1) were docetaxel 50 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Esophageal Cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Taxotere
Other Intervention Name(s)
Docetaxel
Intervention Description
X mg/m2, IV (in the vein) on day 1 of each 28 day cycle. Number of Cycles: until progression or unacceptable toxicity develops.
Intervention Type
Drug
Intervention Name(s)
5-FU
Other Intervention Name(s)
5-Fluorouracil
Intervention Description
800 mg/m2, CIV (conti.in the vein) on day 1~4 of each 28 day cycle. Number of Cycles: until progression or unacceptable toxicity develops.
Intervention Type
Drug
Intervention Name(s)
Briplatin
Other Intervention Name(s)
Cisplatin,CDDP
Intervention Description
15 mg/m2, IV (in the vein) on day 1~4 of each 28 day cycle. Number of Cycles: until progression or unacceptable toxicity develops.
Primary Outcome Measure Information:
Title
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.
Time Frame
one year
Secondary Outcome Measure Information:
Title
Determine the MST(Median Survival Time) and PFS(Progression Free Survival) in Phase II setting.
Time Frame
one year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Masahiro Asaka, MD, PhD
Organizational Affiliation
Hokkaido Gastrointestinal Cancer Study Group
Official's Role
Study Chair
Facility Information:
Facility Name
・ Hokkaido University Hospital (Hokkaido University Graduate School of Medicine / School of Medicine)
City
Sapporo
State/Province
Hokkaido
ZIP/Postal Code
060-8638
Country
Japan

12. IPD Sharing Statement

Learn more about this trial

Phase I/II Study of TPF as First-line Chemotherapy in Patients With Metastatic Esophageal Cancer.

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