A Study on Predictive Value of ERCC1 in Esophageal Cancer Patients Treated With Paclitaxel and Cisplatin

This study is currently recruiting participants. (see Contacts and Locations)
Verified May 2014 by Chinese Academy of Medical Sciences
Sponsor:
Collaborator:
Beijing Municipal Science & Technology Commission
Information provided by (Responsible Party):
Jing Huang, Chinese Academy of Medical Sciences
ClinicalTrials.gov Identifier:
NCT01444547
First received: September 28, 2011
Last updated: May 2, 2014
Last verified: May 2014
  Purpose

The purpose of this study is to evaluate the efficacy and safety of first-line chemotherapy with cisplatin and paclitaxel in esophageal cancer


Condition Intervention Phase
Esophageal Cancer
Drug: paclitaxel and cisplatin
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase Ⅱ Study on Low-expression and High-expression of ERCC1 in Recurrent or Metastastic Esophageal Cancer Patients Treated With Biweekly Paclitaxel and Cisplatin

Resource links provided by NLM:


Further study details as provided by Chinese Academy of Medical Sciences:

Primary Outcome Measures:
  • Overall response rate (ORR) [ Time Frame: 5 year ] [ Designated as safety issue: Yes ]
    The primary objective of this study is to determine the response rate of paclitaxel plus cisplatin as first-line therapy in patients with locally advanced, recurrent or metastatic esophageal carcinoma


Secondary Outcome Measures:
  • Time to event efficay [ Time Frame: 5 year ] [ Designated as safety issue: No ]

    The following time to event efficacy measures:

    • Duration of overall response for responding patients
    • Time to documented progressive disease
    • Overall survival
    • The quantitative and qualitative toxicity of paclitaxel plus cisplatin.
    • Determinant of efficacy of the treatment with paclitaxel and cisplatin in the patient population by means of the analysis of ERCC1


Estimated Enrollment: 92
Study Start Date: January 2007
Estimated Study Completion Date: December 2015
Estimated Primary Completion Date: December 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: single-arm Paclitaxel-Cisplatin Drug: paclitaxel and cisplatin

Paclitaxel 150 mg/m2 will be administered as an intravenous (IV) infusion over 3 hour on Days 1; Cisplatin 50 mg/m2 will be administered as an intravenous (IV) infusion on Days 2, and to take enough hydration in the day and the next day.

14 days as a cycle, up to 8 cycles.

Other Name: Paclitaxel,Beijing Union Pharmaceutical Factory

Detailed Description:

Open label single arm phase II study of cisplatin and paclitaxel in patients with recurrent or metastatic esophageal cancer. 92 Patients will be enrolled in this local trial. The primary objective of this study is to determine the response rate of the treatment.Schedule for this study is as follows: paclitaxel 150 mg/m2 will be administered as an intravenous infusion over 3 hour on Days 1, followed by cisplatin 50 mg/m2 on Days 2. This study will also include the investigation of ERCC1 expression in order to assess determinants of efficacy of the treatment with cisplatin and paclitaxel in the study population.

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Histologically proven diagnosis of the squamous cell carcinoma or adenocarcinoma of esophagus
  • locally advanced, recurrent or metastatic disease
  • Performance Status of 0-2 on the Eastern Cooperative Oncology Group (ECOG) performance status Scale
  • Previous adjuvant or pre-operative chemotherapy without containing paclitaxel or platinum at least 12 months before enrollment
  • Adequate organ function including the following:

Bone marrow: absolute neutrophil count (ANC) >or equal to 1.5 * 109/L, platelets >or equal to 100 *109/L, hemoglobin > or equal to 10 g/dL.

Hepatic: bilirubin < or equal to 1.5 x ULN; alkaline phosphatase, aspartate transaminase (AST) and alanine transaminase (ALT) < or equal to 3 x ULN (alkaline phosphatase, AST, ALT minor or equal to 5 x ULN is acceptable if liver has tumor involvement), serum albumin > or equal to3g/dL.

Renal: Calculated creatinine clearance major or equal to 60 ml/min (using the standard Cockcroft-Gault formula).

Exclusion Criteria:

  • No Prior palliative chemotherapy for advanced disease
  • Previous radiation therapy is allowed but should have been limited and must not have included whole pelvis radiation. Patients must have recovered from the toxic effects of the treatment prior to study enrollment (except for alopecia). Prior radiotherapy must be completed at least 30 days before study enrollment
  • Known or suspected brain metastasis
  • Second primary malignancy
  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: NCT01444547

Contacts
Contact: Yi Zhou, M.D 8610-87788800 mondaycm@yahoo.com.cn
Contact: Xiao Lv, M.D 8610-87788800 xiaoxiao81473@126.com

Locations
China
Cancer Institute and Hospital, Chinese Academy of Medical Sciences Recruiting
Beijing, China, 100021
Contact: Yi Zhou, M.D    8610-87788800    mondaycm@yahoo.com.cn   
Contact: Xiao Lv, M.D    8610-87788800    xiaoxiao81473@126.com   
Principal Investigator: Jing Huang, M.D.,Ph.D         
Sponsors and Collaborators
Chinese Academy of Medical Sciences
Beijing Municipal Science & Technology Commission
Investigators
Principal Investigator: Jing Huang, M.D.,Ph.D Cancer Institute and Hospital, Chinese Academy of Medical Sciences
  More Information

Publications:
Responsible Party: Jing Huang, Principle Investigator, Chinese Academy of Medical Sciences
ClinicalTrials.gov Identifier: NCT01444547     History of Changes
Other Study ID Numbers: CH-GI-021, Z111107058811023
Study First Received: September 28, 2011
Last Updated: May 2, 2014
Health Authority: China: Beijing Municipal Science and Technology Commission
China: Ministry of Health

Keywords provided by Chinese Academy of Medical Sciences:
esophageal cancer
paclitaxel
cisplatin

Additional relevant MeSH terms:
Esophageal Neoplasms
Digestive System Diseases
Digestive System Neoplasms
Esophageal Diseases
Gastrointestinal Diseases
Gastrointestinal Neoplasms
Head and Neck Neoplasms
Neoplasms
Neoplasms by Site
Cisplatin
Paclitaxel
Antimitotic Agents
Antineoplastic Agents
Antineoplastic Agents, Phytogenic
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Radiation-Sensitizing Agents
Therapeutic Uses
Tubulin Modulators

ClinicalTrials.gov processed this record on October 21, 2014