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

• Sponsor: Hokkaido Gastrointestinal Cancer Study Group (Other)
• Overall Status: Completed
• CT.gov ID: NCT00209690
• Collaborator: Hokkaido University Hospital (Other)
• Enrollment: 30
• Location: 1
• Arm: 1
• Duration (Months): 78
• Patients Per Site Per Month: 0.4

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Esophageal Cancer	Drug: Taxotere; Drug: 5-FU; Drug: Briplatin	Phase 1/Phase 2

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.

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 30 participants
• Allocation: Non-Randomized
• Intervention Model: Single Group Assignment
• Masking: None (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.
• Study Start Date: Oct 1, 2003
• Actual Primary Completion Date: Dec 1, 2009
• Actual Study Completion Date: Apr 1, 2010

Arms and Interventions

Arm

Intervention/Treatment

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 Names: 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 Names: 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 Names: Cisplatin,CDDP

Outcome Measures

Primary Outcome Measures

1. 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. [one year]

Secondary Outcome Measures

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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 20 Years to 75 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Locations

	Site	City	State	Country	Postal Code
1	・ 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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT00209690
• Other Study ID Numbers: HGCSG0305-1; TPF
• First Posted: Sep 21, 2005
• Last Update Posted: May 26, 2010
• Last Verified: May 1, 2010

• Additional relevant MeSH terms: Esophageal Neoplasms; Cisplatin; Docetaxel; Fluorouracil

Study Results

No Results Posted as of May 26, 2010