Phase I/II Study of TPF as First-line Chemotherapy in Patients 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:
NCT00209690
First received: September 13, 2005
Last updated: May 24, 2010
Last verified: May 2010
  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 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 Intervention Phase
Esophageal Cancer
Drug: Taxotere
Drug: 5-FU
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 1st-line Chemotherapy in Patients With Metastatic Esophageal Cancer.

Resource links provided by NLM:


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

Secondary Outcome Measures:
  • Determine the MST(Median Survival Time) and PFS(Progression Free Survival) in Phase II setting. [ Time Frame: one year ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 30
Study Start Date: October 2003
Study Completion Date: April 2010
Primary Completion Date: December 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: 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 Name: 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 Name: Cisplatin,CDDP

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.

  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 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00209690

Locations
Japan
・ 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
  More Information

No publications provided

Responsible Party: Yoshito Komatsu / A vice-director,, Hokkaido Gastrointestina Cancer Study Group
ClinicalTrials.gov Identifier: NCT00209690     History of Changes
Other Study ID Numbers: HGCSG0305-1, TPF
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 Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Head and Neck Neoplasms
Digestive System Diseases
Esophageal Diseases
Gastrointestinal Diseases
Docetaxel
Cisplatin
Fluorouracil
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Radiation-Sensitizing Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antimetabolites, Antineoplastic
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators

ClinicalTrials.gov processed this record on September 14, 2014