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

This study has been completed.
Sponsor:
Collaborator:
Hokkaido University Hospital
Information provided by:
Hokkaido Gastrointestinal Cancer Study Group
ClinicalTrials.gov Identifier:
NCT00209716
First received: September 13, 2005
Last updated: May 24, 2010
Last verified: May 2010
History of Changes
  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 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.


Condition Intervention Phase
Esophageal Cancer
 Drug: Taxotere
Drug: 5-Fluorouracil
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 Chemotherapy in Pre-treated Patients With Metastatic Esophageal Cancer.

Resource links provided by NLM:

U.S. FDA Resources

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: 1 year ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Determine the clinical response rate of patients in Phase I setting. [ Time Frame: 1-year ] [ Designated as safety issue: Yes ]
  • Determine the MST(Median Survival Time) and PFS(Progression Free Survival) in Phase II setting. [ Time Frame: 2-years ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 30
Study Start Date: December 2003
Study Completion Date: November 2009
Primary Completion Date: October 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 Drug: Taxotere
30 mg/m2, IV (in the vein) on day 1 of each 28 day cycle.
Other Name: Docetaxel
Drug: 5-Fluorouracil
800 mg/m2, CIV (CIV.in the vein) on day 1~5 of each 28 day cycle.
Other Name: fluorouracil
Drug: Briplatin
15 mg/m2, IV (in the vein) on day 1~4 of each 28 day cycle.
Other Name: Cisplatin

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.

  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 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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00209716

Locations
Japan
・ Hokkaido University Hospital (Hokkaido University Graduate 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, Associate Prof., Hokkaido University Hospital Cancer Center
ClinicalTrials.gov Identifier: NCT00209716     History of Changes
Other Study ID Numbers: HGCSG0305-2, TPF-2
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 June 18, 2013