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

NCT00209716 | Completed Phase 1 DMC

• 2 other identifiers: HGCSG0305-2TPF-2
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Esophageal Cancer

Outcome Measures

Primary Outcomes (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.

  1 year

Secondary Outcomes (2)

• Determine the clinical response rate of patients in Phase I setting.

  1-year

• Determine the MST(Median Survival Time) and PFS(Progression Free Survival) in Phase II setting.

  2-years

Study Arms (1)

1

EXPERIMENTAL

Drug: Taxotere; Drug: 5-Fluorouracil; Drug: Briplatin

Interventions

Taxotere DRUG

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

Also known as: Docetaxel

1

5-Fluorouracil DRUG

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

Also known as: fluorouracil

1

Briplatin DRUG

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

Also known as: Cisplatin

1

Eligibility Criteria

• Age: 20 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Hokkaido Gastrointestinal Cancer Study Group: lead
• Hokkaido University Hospital: collaborator

Study Sites (1)

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

Sapporo, Hokkaido, 060-8638, Japan

Location

MeSH Terms

Conditions

Esophageal Neoplasms

Interventions

Docetaxel; Fluorouracil; Cisplatin

Condition Hierarchy (Ancestors)

Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Head and Neck Neoplasms; Digestive System Diseases; Esophageal Diseases; Gastrointestinal Diseases

Intervention Hierarchy (Ancestors)

Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes; Uracil; Pyrimidinones; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Chlorine Compounds; Inorganic Chemicals; Nitrogen Compounds; Platinum Compounds

Study Officials

• Masahiro Asaka, MD, PhD

  Hokkaido Gastrointestinal Cancer Study Group

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: September 13, 2005
• First Posted: September 21, 2005
• Study Start: December 1, 2003
• Primary Completion: October 1, 2009
• Study Completion: November 1, 2009
• Last Updated: May 26, 2010

Record last verified: 2010-05

Locations

JP (1)