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Phase I/II Study of Docetaxel, Cisplatin and 5-fluorouracil(TPF) as Chemotherapy in Pre-treated Patients With Metastatic Esophageal Cancer.


Phase 1/Phase 2
20 Years
75 Years
Not Enrolling
Both
Esophageal Cancer

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Trial Information

Phase I/II Study of Docetaxel, Cisplatin and 5-fluorouracil(TPF) as Chemotherapy in Pre-treated Patients With Metastatic Esophageal Cancer.


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.


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

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

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.

Outcome Time Frame:

1 year

Safety Issue:

Yes

Principal Investigator

Masahiro Asaka, MD, PhD

Investigator Role:

Study Chair

Investigator Affiliation:

Hokkaido Gastrointestinal Cancer Study Group

Authority:

Japan: Ministry of Health, Labor and Welfare

Study ID:

HGCSG0305-2

NCT ID:

NCT00209716

Start Date:

December 2003

Completion Date:

November 2009

Related Keywords:

  • Esophageal Cancer
  • Esophageal Diseases
  • Esophageal Neoplasms

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