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Phase I/II Trial of Combination Chemotherapy With Docetaxel, Cisplatin and 5-FU for Unresectable Advanced Esophageal Cancer.


Phase 1/Phase 2
20 Years
N/A
Open (Enrolling)
Both
Esophageal Cancer

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Trial Information

Phase I/II Trial of Combination Chemotherapy With Docetaxel, Cisplatin and 5-FU for Unresectable Advanced Esophageal Cancer.




Primary Objective:

To establish the safety of combination chemotherapy comprising docetaxel (escalating doses:
25,30,35,40 mg/m2,day1 and day8), cisplatin (12mg/m2,day1-5), and fluorouracil
(600mg/m2,day1-5) (DCF) in unresectable advanced esophageal cancer.

Secondary Objective:

To observe the efficacy of this regimen in these patients.



Primary Objective:

To assess the response rate of combination chemotherapy comprising docetaxel (recommended
dose determined in phase I study,day1 and day8), cisplatin (12 mg/m2, day1-5), and
fluorouracil (600 mg/m2, day1-5) (DCF) in unresectable advanced esophageal cancer.

Secondary Objectives:

To determine the adverse reactions of this regimen in these patients. To determine TTP(Time
to progression) of patients treated with this regimen. To determine MST(Median survival
time) of patients treated with this regimen.


Inclusion Criteria:



- locally advanced or metastatic esophageal cancer precluding curative surgical
resection and recurrent esophageal cancer measurable disease by CT scan

- ECOG performance status 0-1

- 20 years and older

- Patients must have clinically documented unresectable or metastatic esophageal cancer
and histologic confirmation of the diagnosis with tumor

- Tissue from tumor must be available

- Patients must have measurable disease

- Patients may have received prior adjuvant chemotherapy; this must have been completed
at least 1 month

- Life expectancy > 3 months

- Laboratory values as follows

- 3000/mm3 < WBC < 12000/mm3

- 1500/mm3 < granulocyte count

- 8.0 gm/dl < hemoglobin

- Platelet count > 100000/mm3

- Aspartate transaminase < 150 IU/L

- Alanine transaminase < 150 IU/L

- Creatinine < 1.5 mg/dl

- Able and willing to give valid written informed consent

Exclusion Criteria:

- Pregnancy (women of childbearing potential: refusal or inability to use effective
means of contraception)

- Active or uncontrolled infection

- Prior chemotherapy or radiation therapy within 4 weeks, surgery within 3 weeks or
immunotherapy within 1 week

- Clinically significant heart disease

- Patients with a history of myocardial infarction within the previous three months

- Patients with uncontrolled diabetes mellitus or hypertension

- Presence of clinically apparent central nervous system metastases

- Patients with any other severe concurrent disease, which in the judgment of the
investigator, would make the patient inappropriate for entry into this study

- Decision of unsuitableness by principal investigator or physician-in-charge

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

Safety (Phase I: toxicities as assessed by NCI CTCAE version3) and efficacy (Phase II: Feasibility as evaluated by RECIST)

Outcome Time Frame:

1 month

Safety Issue:

Yes

Principal Investigator

Makoto Iwahashi, M.D.

Investigator Role:

Study Director

Investigator Affiliation:

Second Department of Surgery, Wakayama Medical University

Authority:

Japan: Ministry of Health, Labor and Welfare

Study ID:

WMU-EC01

NCT ID:

NCT00915850

Start Date:

August 2007

Completion Date:

August 2015

Related Keywords:

  • Esophageal Cancer
  • Carcinoma, Squamous Cell
  • Esophageal Diseases
  • Esophageal Neoplasms

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