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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified May 2014 by Jing Huang, Chinese Academy of Medical Sciences.
Recruitment status was:  Recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT01444547
First Posted: September 30, 2011
Last Update Posted: May 6, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Beijing Municipal Science & Technology Commission
Information provided by (Responsible Party):
Jing Huang, Chinese Academy of Medical Sciences
  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
Intervention Model: Single Group Assignment
Masking: None (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 Jing Huang, Chinese Academy of Medical Sciences:

Primary Outcome Measures:
  • Overall response rate (ORR) [ Time Frame: 5 year ]
    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 ]

    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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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 ( Registry Identifier: CH-GI-021 )
First Submitted: September 28, 2011
First Posted: September 30, 2011
Last Update Posted: May 6, 2014
Last Verified: May 2014

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

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