search
Back to results

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

Primary Purpose

Esophageal Cancer

Status
Unknown status
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
paclitaxel and cisplatin
Sponsored by
Chinese Academy of Medical Sciences
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Esophageal Cancer focused on measuring esophageal cancer, paclitaxel, cisplatin

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Cancer Institute and Hospital, Chinese Academy of Medical SciencesRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

single-arm Paclitaxel-Cisplatin

Arm Description

Outcomes

Primary Outcome Measures

Overall response rate (ORR)
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
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

Full Information

First Posted
September 28, 2011
Last Updated
May 2, 2014
Sponsor
Chinese Academy of Medical Sciences
Collaborators
Beijing Municipal Science & Technology Commission
search

1. Study Identification

Unique Protocol Identification Number
NCT01444547
Brief Title
A Study on Predictive Value of ERCC1 in Esophageal Cancer Patients Treated With Paclitaxel and Cisplatin
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
Study Type
Interventional

2. Study Status

Record Verification Date
May 2014
Overall Recruitment Status
Unknown status
Study Start Date
January 2007 (undefined)
Primary Completion Date
December 2015 (Anticipated)
Study Completion Date
December 2015 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Chinese Academy of Medical Sciences
Collaborators
Beijing Municipal Science & Technology Commission

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Esophageal Cancer
Keywords
esophageal cancer, paclitaxel, cisplatin

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
92 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
single-arm Paclitaxel-Cisplatin
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
paclitaxel and cisplatin
Other Intervention Name(s)
Paclitaxel,Beijing Union Pharmaceutical Factory
Intervention Description
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.
Primary Outcome Measure Information:
Title
Overall response rate (ORR)
Description
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
Time Frame
5 year
Secondary Outcome Measure Information:
Title
Time to event efficay
Description
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
Time Frame
5 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Yi Zhou, M.D
Phone
8610-87788800
Email
mondaycm@yahoo.com.cn
First Name & Middle Initial & Last Name or Official Title & Degree
Xiao Lv, M.D
Phone
8610-87788800
Email
xiaoxiao81473@126.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jing Huang, M.D.,Ph.D
Organizational Affiliation
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Official's Role
Principal Investigator
Facility Information:
Facility Name
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
City
Beijing
ZIP/Postal Code
100021
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yi Zhou, M.D
Phone
8610-87788800
Email
mondaycm@yahoo.com.cn
First Name & Middle Initial & Last Name & Degree
Xiao Lv, M.D
Phone
8610-87788800
Email
xiaoxiao81473@126.com
First Name & Middle Initial & Last Name & Degree
Jing Huang, M.D.,Ph.D

12. IPD Sharing Statement

Citations:
PubMed Identifier
20700125
Citation
Lee S, Park YH, Kim KH, Cho EY, Ahn YC, Kim K, Shim YM, Ahn JS, Park K, Im YH. Thymidine synthase, thymidine phosphorylase, and excision repair cross-complementation group 1 expression as predictive markers of capecitabine plus cisplatin chemotherapy as first-line treatment for patients with advanced oesophageal squamous cell carcinoma. Br J Cancer. 2010 Sep 7;103(6):845-51. doi: 10.1038/sj.bjc.6605831. Epub 2010 Aug 10.
Results Reference
result
PubMed Identifier
17928611
Citation
Olaussen KA, Fouret P, Kroemer G. ERCC1-specific immunostaining in non-small-cell lung cancer. N Engl J Med. 2007 Oct 11;357(15):1559-61. doi: 10.1056/NEJMc072007. No abstract available.
Results Reference
result

Learn more about this trial

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

We'll reach out to this number within 24 hrs