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

NCT ID: NCT00209690

Last Updated: 2010-05-26

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2003-10-31
• Study Completion Date: 2010-04-30

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.

Conditions

Esophageal Cancer

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

1

Group Type: EXPERIMENTAL

Taxotere

Intervention Type: DRUG

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

5-FU

Intervention Type: DRUG

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.

Briplatin

Intervention Type: DRUG

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.

Interventions

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.

Intervention Type: 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.

Intervention Type: 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.

Intervention Type: DRUG

Other Intervention Names

Docetaxel; 5-Fluorouracil; Cisplatin,CDDP

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

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Hokkaido University Hospital

OTHER

Sponsor Role: collaborator

Hokkaido Gastrointestinal Cancer Study Group

OTHER

Sponsor Role: lead

Responsible Party

Hokkaido Gastrointestina Cancer Study Group

Principal Investigators

Masahiro Asaka, MD, PhD

Role: STUDY_CHAIR

Hokkaido Gastrointestinal Cancer Study Group

Locations

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

Sapporo, Hokkaido, Japan

Countries

Japan

Other Identifiers

TPF

Identifier Type: -

Identifier Source: secondary_id

HGCSG0305-1

Identifier Type: -

Identifier Source: org_study_id