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Trial record 2 of 6 for:    TNFRSF1B

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

This study is currently recruiting participants. (see Contacts and Locations)
Verified December 2013 by Nang Kuang Pharmaceutical Co., Ltd.
Sponsor:
Information provided by (Responsible Party):
Nang Kuang Pharmaceutical Co., Ltd.
ClinicalTrials.gov Identifier:
NCT02017600
First received: December 9, 2013
Last updated: December 22, 2013
Last verified: December 2013
  Purpose

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.


Condition Intervention Phase
Localized Squamous Cell Carcinoma of the Esophagus
Drug: ND-420
Procedure: Surgery
Drug: Cisplatin
Drug: fluorouracil
Phase 2

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Nang Kuang Pharmaceutical Co., Ltd.:

Primary Outcome Measures:
  • the R0 resection rate of participants [ Time Frame: up to three months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • the response rate (RECIST) of participants [ Time Frame: up to three months ] [ Designated as safety issue: No ]
  • Number of participants with adverse events as a measure of safety and tolerability [ Time Frame: up to one year ] [ Designated as safety issue: Yes ]
  • the population pharmacokinetic parameters (Cmax, AUC... )of ND-420 in the participants [ Time Frame: 0, 30min, 1hr of ND-420 infusion. selected randomly form one of 3hr, 7hr, 11hr and 23hr after the end of ND-420 infusion. ] [ Designated as safety issue: No ]
  • the correlation between clinical outcomes and the potential predictive genomic biomarkers(B-tubulin mutation, p53-Arg 72Pro, Bcl2-C938A, MDR1-C3435T polymorphism, TNFRSF1B-1466, GSTP1-l105V, CYP1B1, TS-5'UTR) for tumor response [ Time Frame: up to one year ] [ Designated as safety issue: No ]
  • 1-year survival rate of participants [ Time Frame: up to one year ] [ Designated as safety issue: No ]
  • pathologic complete response rate of participants [ Time Frame: up to one year ] [ Designated as safety issue: No ]
  • 1-year progression free survival rate of participants [ Time Frame: up to one year ] [ Designated as safety issue: No ]
  • 1-year overall survival rate of participants [ Time Frame: up to one year ] [ Designated as safety issue: No ]

Estimated Enrollment: 48
Study Start Date: August 2013
Estimated Study Completion Date: September 2015
Estimated Primary Completion Date: September 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Induction Chemotherapy DCF followed by Surgery
All eligible patients will receive ND-420, Cisplatin and fluorouracil every 3 weeks for 2 cycles. After induction chemotherapy, patients will be planned to receive Surgery.
Drug: ND-420
ND-420 50 mg/m2 on day1
Other Name: ND-420(Nangkuang)
Procedure: Surgery
After induction chemotherapy, participants will be receive right or left thoracotomy for curative resection by total or subtotal thoracic esophagectomy.
Drug: Cisplatin
cisplatin 70 mg/m2 on day1
Drug: fluorouracil
fluorouracil 700 mg/m2 daily, day1 to day4
Other Name: 5-FU

  Eligibility

Ages Eligible for Study:   20 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  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: NCT02017600

Locations
Taiwan
Taipei Veterans General Hospital Recruiting
Taipei, Taiwan, 112
Contact: Shiang-yih Ho, Master    886-978661611    r98426006@ntu.edu.tw   
Principal Investigator: Ming-Huang Chen, M.D.         
Sub-Investigator: Chueh-chuan Yen, M.D.         
Sub-Investigator: Wen-Hu Hsu, M.D.         
Sub-Investigator: Yu-Chung Wu, M.D.         
Sub-Investigator: Chih-Cheng Hsieh, M.D.         
Sub-Investigator: Chien-Sheng Huang, M.D.         
Sub-Investigator: Po-Kuei Hsu, M.D.         
Sub-Investigator: Jung-Jyh Hung, M.D.         
Sub-Investigator: Sheng-Yu Chen, M.D.         
Sub-Investigator: Yu-Ming Liu, M.D.         
Sub-Investigator: Yi-Wei Chen, M.D.         
Sub-Investigator: Ko-Han Lin, M.D.         
Sub-Investigator: Mei-Han Wu, M.D.         
Sub-Investigator: Hsiao-Ping Chou, M.D.         
Sub-Investigator: Jiing-Chyuan Luo, M.D.         
Sub-Investigator: Teh-Ying Chou, M.D.         
Sponsors and Collaborators
Nang Kuang Pharmaceutical Co., Ltd.
Investigators
Principal Investigator: Ming-Huang Chen, M.D. Taipei Veterans General Hospital, Taiwan
  More Information

No publications provided

Responsible Party: Nang Kuang Pharmaceutical Co., Ltd.
ClinicalTrials.gov Identifier: NCT02017600     History of Changes
Other Study ID Numbers: NKCND420/201112
Study First Received: December 9, 2013
Last Updated: December 22, 2013
Health Authority: Taiwan : Food and Drug Administration

Additional relevant MeSH terms:
Carcinoma
Carcinoma, Squamous Cell
Esophageal Neoplasms
Digestive System Diseases
Digestive System Neoplasms
Esophageal Diseases
Gastrointestinal Diseases
Gastrointestinal Neoplasms
Head and Neck Neoplasms
Neoplasms
Neoplasms by Histologic Type
Neoplasms by Site
Neoplasms, Glandular and Epithelial
Neoplasms, Squamous Cell
Cisplatin
Fluorouracil
Antimetabolites
Antimetabolites, Antineoplastic
Antineoplastic Agents
Immunologic Factors
Immunosuppressive Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Radiation-Sensitizing Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on November 25, 2014