Clinical trial NCT00915850: Trial of Docetaxel, Cisplatin, Fluorouracil (5-FU) for Unresectable Advanced Esophageal Squamous Cell Carcinoma (ESCC)
Official title: Phase I/II Trial of Combination Chemotherapy With Docetaxel, Cisplatin and 5-FU for Unresectable Advanced Esophageal Cancer.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
PHASE2
Conditions: Esophageal Cancer
Lead sponsor: Wakayama Medical University
Sponsor class: OTHER
First posted: 2009-06-08
Enrollment: 32
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This phase I/II study is being conducted to determine the maximum-tolerated dose (MTD), dose-limiting toxicity (DLT), and efficacy of a combination chemotherapy using docetaxel, cisplatin and 5-fluorouracil (DCF) in unresectable advanced esophageal cancer. The usefulness of the this regimen is evaluated by RECIST, time to progression and median survival time.

Detailed description: \<Phase I\>

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.

\<Phase II\>

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.

Eligibility criteria: 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

Primary outcomes:
measure: Safety (Phase I: toxicities as assessed by NCI CTCAE version3) and efficacy (Phase II: Feasibility as evaluated by RECIST)
timeFrame: 1 month
Secondary outcomes:
measure: To determine the recommended phase II dose of docetaxel (Phase I)
timeFrame: 1 month
measure: To determine the clinical effectiveness in the patients with measurable disease (Phase I)
timeFrame: 1 month
measure: To analyze the toxicity (Phase II)
timeFrame: 1 month
measure: Time to progression (Phase II)
timeFrame: 5 years
measure: median survival time (Phase II)
timeFrame: 5 years
Other outcomes:
Locations:
city: Wakayama
country: Japan
facility: Wakayama Medical University
Study officials:
affiliation: Second Department of Surgery, Wakayama Medical University
name: Makoto Iwahashi, M.D.
role: STUDY_DIRECTOR
References: