Phase I/II Study of TPF as First-Line Chemotherapy in Patients With Metastatic Esophageal Cancer. - Full Text View

Sponsors and Collaborators:	Hokkaido Gastrointestinal Cancer Study Group Hokkaido University Hospital
Information provided by:	Hokkaido Gastrointestinal Cancer Study Group
ClinicalTrials.gov Identifier:	NCT00209690

Purpose

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.

Condition	Intervention	Phase
Esophageal Cancer	Drug: Taxotere Drug: 5-FU Drug: Briplatin	Phase I Phase II

MedlinePlus related topics: Cancer Esophageal Cancer Esophagus Disorders

Drug Information available for: Docetaxel Cisplatin Fluorouracil

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
Official Title:	Phase I/II Study of Docetaxel, Cisplatin and 5-Fluorouracil(TPF) as 1st-Line Chemotherapy in Patients With Metastatic Esophageal Cancer.

Further study details as provided by Hokkaido Gastrointestinal Cancer Study Group:

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. [ Time Frame: one year ]

Secondary Outcome Measures:

Determine the MST(Median Survival Time) and PFS(Progression Free Survival) in Phase II setting. [ Time Frame: one year ]

Estimated Enrollment:	30
Study Start Date:	October 2003
Estimated Study Completion Date:	November 2008

Arms	Assigned Interventions
1: Experimental	Drug: Taxotere X mg/m2, IV (in the vein) on day 1 of each 28 day cycle. Number of Cycles: until progression or unacceptable toxicity develops. Drug: 5-FU 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. Drug: Briplatin 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.

Arms

Assigned Interventions

1: Experimental

Drug: Taxotere

X mg/m2, IV (in the vein) on day 1 of each 28 day cycle. Number of Cycles: until progression or unacceptable toxicity develops.

Drug: 5-FU

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.

Drug: Briplatin

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.

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.

Eligibility

Ages Eligible for Study:	20 Years to 75 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00209690

Contacts

Contact: Yoshito Komatsu, MD, PhD	+81-11-716-1161	ykomatsu@med.hokudai.ac.jp
Contact: Satoshi Yuki, MD	+81-11-716-1161	satoshi-yuuki175@joy.ocn.ne.jp

Locations

Japan, Hokkaido
・ Hokkaido University Hospital (Hokkaido University Graduate School of Medicine / School of Medicine)	Recruiting
Sapporo, Hokkaido, Japan, 060-8638
Contact: Yoshito Komatsu, MD, PhD +81-11-716-1161 ykomatsu@med.hokudai.ac.jp
Contact: Satoshi Yuki, MD +81-11-716-1161 satoshi-yuuki175@joy.ocn.ne.jp

Sponsors and Collaborators

Hokkaido Gastrointestinal Cancer Study Group

Hokkaido University Hospital

Investigators

Study Chair:

Masahiro Asaka, MD, PhD

Hokkaido Gastrointestinal Cancer Study Group

More Information

Study ID Numbers:	HGCSG0305-1, TPF
Study First Received:	September 13, 2005
Last Updated:	October 31, 2007
ClinicalTrials.gov Identifier:	NCT00209690
Health Authority:	Japan: Ministry of Health, Labor and Welfare

Study placed in the following topic categories:

Docetaxel
Digestive System Neoplasms
Digestive System Diseases
Cisplatin
Esophageal disorder
Gastrointestinal Diseases

Fluorouracil
Head and Neck Neoplasms
Esophageal Neoplasms
Gastrointestinal Neoplasms
Esophageal Diseases
Esophageal neoplasm

Additional relevant MeSH terms:

Antimetabolites
Neoplasms
Antimetabolites, Antineoplastic
Neoplasms by Site
Immunologic Factors
Molecular Mechanisms of Pharmacological Action

Antineoplastic Agents
Therapeutic Uses
Physiological Effects of Drugs
Immunosuppressive Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009