A Phase II Trial of Induction Chemotherapy With ND-420, Cisplatin and Fluorouracil Followed by Surgery in the Treatment of Patients With Localized Squamous Cell Carcinoma of the Esophagus
Conditions
Localized Squamous Cell Carcinoma of the Esophagus
Conditions: official terms
Carcinoma - Carcinoma, Squamous Cell - Esophageal Neoplasms
Study Type
Interventional
Study Phase
Phase 2
Study Design
Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Intervention
Name: ND-420 Type: Drug
Name: Surgery Type: Procedure
Name: Cisplatin Type: Drug
Name: fluorouracil Type: Drug
Overall Status
Recruiting
Summary
Investigator will assign 53 patients who had been histologically proven localized squamous cell carcinoma of esophagus to receive the induction chemotherapy regimen of ND-420 50 mg/m2 on day 1, cisplatin 70 mg/m2 on day1, plus fluorouracil 700 mg/m2 daily, day1 to day4, every 3 weeks for 2 cycles and then followed by surgical resection. The successful rate of complete treatment per protocol and complete resection will be the primary variant to evaluate in our study.
Criteria for eligibility
Healthy Volunteers: No
Maximum Age: N/A
Minimum Age: 20 Years
Gender: Both
Criteria: Inclusion Criteria:

- Patients must have been histologically proven esophageal carcinoma (squamous cell carcinoma).

- The tumor had to be locally advanced (stage T2-3/N0, T1-3/N+, if technically resectable with curative intent).

- Patients must be 20 years of age.

- Patients must have an ECOG performance status score 2.

- Patients must have a life expectancy of at least 12 weeks.

- Patients must be accessible for treatment and follow-up at least for one year.

- Patients must sign the informed consent form.

- Patient must have:Hemoglobin level 9 g/dl; Neutrophil count 1,500/mm3; Platelets count 100,000/mm3; Serum bilirubin level 1.0 ULN; Serum transaminase (GOT, GPT) levels 2.0 ULN; Serum Alkaline phosphatase levels 2.0 ULN; Serum creatinine level 1.5 mg/dl or Creatinine clearance rate(CrCl)60 ml/min for the institution (calculated by the Cockcroft- Gault equation).

Exclusion Criteria:

- Patient who are receiving or had received concurrent radiotherapy, chemotherapy or other anticancer treatment for esophageal carcinoma.

- Patients with known history of severe hypersensitivity reactions to any medicine or to drugs formulated with polysorbate 80.

- Major surgery within two weeks prior to entering the study, excluding port-A insertion or feeding jejunostomy surgery.

- Patients with CNS metastasis, including clinical suspicion.

- Patients with clinically detectable peripheral neuropathy 2 on the CTC criteria.

- Mental statuses of patients are not fit for clinical trial.

- Fertile men and women unless using a reliable and appropriate contraceptive method.

- Patients with pregnancy or lactating, women considering pregnancy, possible pregnancy that without using effective contraception.

- Patients who have serious concomitant illness that might be aggravated by chemotherapy, as below included:Active cardiac disease (e.g. congestive heart failure, angina, arrhythmia, acute myocardial disease or other types of heart disease requiring treatment) within 6 months period preceding entry into the study; Uncontrolled infection (e.g. active infection that uncontrolled for 2 weeks under antibiotic therapy); Retention of body fluid (e.g. pleural effusion, ascites, pericardial effusion, and edema needing treatment); History of other than esophageal cancer, except curatively treated non-melanoma skin cancer or in situ carcinoma of the esophagus; and other conditions which will be judged by physician's discretion.
Location
Taipei Veterans General Hospital
Taipei, Taiwan
Status: Recruiting
Contact: Shiang-yih Ho, Master - 886-978661611 - r98426006@ntu.edu.tw
Start Date
August 2013
Completion Date
September 2015
Sponsors
Nang Kuang Pharmaceutical Co., Ltd.
Source
Nang Kuang Pharmaceutical Co., Ltd.
Record processing date
ClinicalTrials.gov processed this data on July 28, 2015
ClinicalTrials.gov page