Phase I/II Study of Taxotere,CDDP and 5-FU(TPF) in Pre-treated Pts With Metastatic Esophageal Cancer.

NCT ID: NCT00209716

Last Updated: 2010-05-26

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2003-12-31
• Study Completion Date: 2009-11-30

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 Pre-treated 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 pre-treated 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 30 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

30 mg/m2, IV (in the vein) on day 1 of each 28 day cycle.

5-Fluorouracil

Intervention Type: DRUG

800 mg/m2, CIV (CIV.in the vein) on day 1\~5 of each 28 day cycle.

Briplatin

Intervention Type: DRUG

15 mg/m2, IV (in the vein) on day 1\~4 of each 28 day cycle.

Interventions

Taxotere

30 mg/m2, IV (in the vein) on day 1 of each 28 day cycle.

Intervention Type: DRUG

5-Fluorouracil

800 mg/m2, CIV (CIV.in the vein) on day 1\~5 of each 28 day cycle.

Intervention Type: DRUG

Briplatin

15 mg/m2, IV (in the vein) on day 1\~4 of each 28 day cycle.

Intervention Type: DRUG

Other Intervention Names

Docetaxel; fluorouracil; Cisplatin

Eligibility Criteria

Inclusion Criteria

• Histologically confirmed metastatic or recurrent esophageal tumors with 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 ≥ 3.5 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 received 1cycle cancer therapy (radiotherapy, chemotherapy or chemoradiotherapy) given > 4 weeks prior to the beginning of study therapy
• 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 University Hospital Cancer Center

Principal Investigators

Masahiro Asaka, MD, PhD

Role: STUDY_CHAIR

Hokkaido Gastrointestinal Cancer Study Group

Locations

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

Sapporo, Hokkaido, Japan

Countries

Japan

Other Identifiers

TPF-2

Identifier Type: -

Identifier Source: secondary_id

HGCSG0305-2

Identifier Type: -

Identifier Source: org_study_id