Phase I/II Study of TPF as First-line Chemotherapy in Patients With Metastatic Esophageal Cancer.
This study has been completed.
Sponsor:
Hokkaido Gastrointestinal Cancer Study Group
Collaborator:
Hokkaido University Hospital
Information provided by:
Hokkaido Gastrointestinal Cancer Study Group
ClinicalTrials.gov Identifier:
NCT00209690
First received: September 13, 2005
Last updated: May 24, 2010
Last verified: May 2010
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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 1 Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Phase I/II Study of Docetaxel, Cisplatin and 5-fluorouracil(TPF) as 1st-line Chemotherapy in Patients With Metastatic Esophageal Cancer. |
Resource links provided by NLM:
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 ] [ Designated as safety issue: Yes ]
Secondary Outcome Measures:
- Determine the MST(Median Survival Time) and PFS(Progression Free Survival) in Phase II setting. [ Time Frame: one year ] [ Designated as safety issue: Yes ]
| Estimated Enrollment: | 30 |
| Study Start Date: | October 2003 |
| Study Completion Date: | April 2010 |
| Primary Completion Date: | December 2009 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: 1 |
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.
Other Name: Docetaxel
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.
Other Name: 5-Fluorouracil
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.
Other Name: Cisplatin,CDDP
|
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
Locations
| Japan | |
| ・ Hokkaido University Hospital (Hokkaido University Graduate School of Medicine / School of Medicine) | |
| Sapporo, Hokkaido, Japan, 060-8638 | |
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
No publications provided
| Responsible Party: | Yoshito Komatsu / A vice-director,, Hokkaido Gastrointestina Cancer Study Group |
| ClinicalTrials.gov Identifier: | NCT00209690 History of Changes |
| Other Study ID Numbers: | HGCSG0305-1, TPF |
| Study First Received: | September 13, 2005 |
| Last Updated: | May 24, 2010 |
| Health Authority: | Japan: Ministry of Health, Labor and Welfare |
Additional relevant MeSH terms:
|
Esophageal Diseases Esophageal Neoplasms Gastrointestinal Diseases Digestive System Diseases Gastrointestinal Neoplasms Digestive System Neoplasms Neoplasms by Site Neoplasms Head and Neck Neoplasms Docetaxel Cisplatin |
Fluorouracil Antineoplastic Agents Therapeutic Uses Pharmacologic Actions Radiation-Sensitizing Agents Physiological Effects of Drugs Antimetabolites Molecular Mechanisms of Pharmacological Action Antimetabolites, Antineoplastic Immunosuppressive Agents Immunologic Factors |
ClinicalTrials.gov processed this record on May 19, 2013