Home
Search
Study Topics
Glossary
|
|
|
|
|
|
Sponsors and Collaborators: |
Hokkaido Gastrointestinal Cancer Study Group Hokkaido University Hospital |
---|---|
Information provided by: | Hokkaido Gastrointestinal Cancer Study Group |
ClinicalTrials.gov Identifier: | NCT00209690 |
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 |
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. |
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.
|
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.
Ages Eligible for Study: | 20 Years to 75 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
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 |
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 |
Study Chair: | Masahiro Asaka, MD, PhD | Hokkaido Gastrointestinal Cancer Study Group |
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 |
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 |
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 |