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A Phase 2 Trial of Optimizing Platinum-Based Chemotherapy Based on ERCC1 Expression as First-Line Treatment in Patients With Locally Advanced or Metastatic Gastric Cancer

Primary Purpose

Stomach Neoplasms

Status
Terminated
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
Capecitabine+Cisplatin
Docetaxel+Capecitabine
Sponsored by
China Medical University, China
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Stomach Neoplasms focused on measuring Gastric Cancer, ERCC1, Platinum, Chemotherapy

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 18y≤Age≤65y, male or female
  • KPS≥70
  • Histologically confirmed adenocarcinoma of the stomach or gastro-oesophageal junction with inoperable locally advanced or recurrent and/or metastatic disease
  • At least one measurable lesion, according to the Response Evaluation Criteria in Solid Tumors (RECIST 1.1), assessed using imaging techniques (CT or MRI)
  • No prior anti-tumor treatment or an interval of at least 6 months from the last adjuvant chemotherapy, and an interval of at least 4 weeks from the last radical radiation therapy
  • No major organ disorder, with normal liver, kidney and heart function
  • Laboratory test must meet the following criteria: hemoglobin (HGB) ≥90g/L, neutrophil count ≥1.5×109/L, platelet count ≥100×109/L, creatinine clearance rate (CCr) ≥60ml/min, total bilirubin (TBil) ≤1.5 upper normal limitation (UNL), alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤2.5 UNL (For patients with liver metastasis, the AST/ALT must be ≤5.0 UNL), blood glucose ≤11.1 mmol/L
  • Life expectancy of at least 12 weeks
  • Signed informed consent
  • For women with child bearing potential, a negative serum or urine pregnancy test result should be obtained before enrollment

Exclusion Criteria:

  • Progression from prior palliative treatment with capecitabine- or docetaxel-based regimen
  • Serious uncontrolled systemic illness or medical condition: congestive heart failure, unstable angina, history of documented myocardial infarction within 6 months, uncontrolled hypertension and high risk uncontrollable arrhythmias; Obvious neurological or mental abnormalities including mental disorder, epileptic dementia, which affect compliance; Uncontrolled acute infections; Uncontrolled peptic ulcer, diabetes or other contraindication for corticosteroid therapy
  • Inability to take or absorb oral medicine
  • Concurrent administration of any other investigational drug, or have been enrolled in other clinical trial with investigational drug treatment within the 30 days of start of study treatment
  • Presence of neuropathy ≥grade 1 according to NCI-CTCAE V4.0
  • Hypersensitivity or known or suspicious allergic to any of the study drugs
  • Pregnant or lactated women
  • Unsuitable for the study or other chemotherapy determined by investigator

Sites / Locations

  • The Fourth Hospital of Anshan
  • The First Hospital of Dalian Medical University
  • The Second Hospital of Dalian Medical University
  • The First Hospital of Liaoning Medical University
  • The First Hospital of China Medical University
  • Liaoning Tumor Hospital
  • Shengjing Hospital of China Medical University

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Experimental

Active Comparator

Arm Label

H-A: ERCC1 High Expression Group A

H-B: ERCC1 High Expression Group B

L: ERCC1 Low Expression Group

Arm Description

XP：Capecitabine+Cisplatin

DX：Docetaxel+Capecitabine

XP：Capecitabine+Cisplatin

Outcomes

Primary Outcome Measures

Progression-Free Survival (PFS)

Secondary Outcome Measures

Overall Survival(OS)
Objective Response Rate(ORR),Including Complete Response(CR) and Partial Response(PR)
Disease Control Rate(DCR), Including Complete Response(CR) , Partial Response(PR) and Stable Disease(SD)
Duration of Response
Safety(number and degree of adverse events)
Quality of Life(QOL)

Full Information

First Posted
October 15, 2013
Last Updated
May 28, 2019
Sponsor
China Medical University, China
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1. Study Identification

Unique Protocol Identification Number
NCT01967875
Brief Title
A Phase 2 Trial of Optimizing Platinum-Based Chemotherapy Based on ERCC1 Expression as First-Line Treatment in Patients With Locally Advanced or Metastatic Gastric Cancer
Official Title
A Prospective, Multi-Center, Randomized Control Phase 2 Trial of Optimizing Platinum-Based Chemotherapy Based on ERCC1 Expression as First-Line Treatment in Patients With Locally Advanced or Metastatic Gastric Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
May 2019
Overall Recruitment Status
Terminated
Why Stopped
slow enrollment
Study Start Date
July 2013 (Actual)
Primary Completion Date
May 2015 (Actual)
Study Completion Date
May 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
China Medical University, China

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
The purpose of this study is to determine whether ERCC1(excision repair cross-complementation 1 ) expression has effects on platinum-based chemotherapy for patients with locally advanced or metastatic gastric cancer, and to explore if ERCC1 can act as a biological predictor for the individual therapy of gastric cancer
Detailed Description
This is a prospective, multi-center, randomized control clinical trial, aimed to demonstrate if ERCC1 expression could predict the efficacy of platinum-based chemotherapy in patients with locally advanced or metastatic gastric cancer. A total of 180 patients are planned to be enrolled into the study. ERCC1 protein expression in paraffin-embedding tumor tissue is examined by immunohistochemistry (IHC). Patients with low ERCC1 expression (group L) will be treated with XP regimen. Patients with high ERCC1 expression will be randomized into group H-A or group H-B, and be treated with XP or DX regimen, respectively. The primary end point is progression free survival (PFS), and the secondary end points include the median overall survival, objective response rate (ORR),disease control rate(DCR), duration of response, safety(number and degree of adverse events), and the quality of life (QOL).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stomach Neoplasms
Keywords
Gastric Cancer, ERCC1, Platinum, Chemotherapy

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
27 (Actual)

8. Arms, Groups, and Interventions

Arm Title
H-A: ERCC1 High Expression Group A
Arm Type
Active Comparator
Arm Description
XP：Capecitabine+Cisplatin
Arm Title
H-B: ERCC1 High Expression Group B
Arm Type
Experimental
Arm Description
DX：Docetaxel+Capecitabine
Arm Title
L: ERCC1 Low Expression Group
Arm Type
Active Comparator
Arm Description
XP：Capecitabine+Cisplatin
Intervention Type
Drug
Intervention Name(s)
Capecitabine+Cisplatin
Other Intervention Name(s)
Xeloda
Intervention Description
Cisplatin 75mg/m2, d1; Capecitabine 1700-2000mg/m2/day on days1-14 every 21 days, 6 cycles.Capecitabine is to be continued until disease progression or intolerable toxicity.
Intervention Type
Drug
Intervention Name(s)
Docetaxel+Capecitabine
Other Intervention Name(s)
Docetaxel for injection, Xeloda
Intervention Description
Docetaxel 75mg/m2, d1; Capecitabine 1700-2000mg/m2/day on days1-14 every 21 days, 6 cycles. Capecitabine is to be continued until disease progression or intolerable toxicity.
Primary Outcome Measure Information:
Title
Progression-Free Survival (PFS)
Time Frame
2 years
Secondary Outcome Measure Information:
Title
Overall Survival(OS)
Time Frame
2 years
Title
Objective Response Rate(ORR),Including Complete Response(CR) and Partial Response(PR)
Time Frame
2 years
Title
Disease Control Rate(DCR), Including Complete Response(CR) , Partial Response(PR) and Stable Disease(SD)
Time Frame
2 years
Title
Duration of Response
Time Frame
2 years
Title
Safety(number and degree of adverse events)
Time Frame
2 years
Title
Quality of Life(QOL)
Time Frame
2 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 18y≤Age≤65y, male or female KPS≥70 Histologically confirmed adenocarcinoma of the stomach or gastro-oesophageal junction with inoperable locally advanced or recurrent and/or metastatic disease At least one measurable lesion, according to the Response Evaluation Criteria in Solid Tumors (RECIST 1.1), assessed using imaging techniques (CT or MRI) No prior anti-tumor treatment or an interval of at least 6 months from the last adjuvant chemotherapy, and an interval of at least 4 weeks from the last radical radiation therapy No major organ disorder, with normal liver, kidney and heart function Laboratory test must meet the following criteria: hemoglobin (HGB) ≥90g/L, neutrophil count ≥1.5×109/L, platelet count ≥100×109/L, creatinine clearance rate (CCr) ≥60ml/min, total bilirubin (TBil) ≤1.5 upper normal limitation (UNL), alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤2.5 UNL (For patients with liver metastasis, the AST/ALT must be ≤5.0 UNL), blood glucose ≤11.1 mmol/L Life expectancy of at least 12 weeks Signed informed consent For women with child bearing potential, a negative serum or urine pregnancy test result should be obtained before enrollment Exclusion Criteria: Progression from prior palliative treatment with capecitabine- or docetaxel-based regimen Serious uncontrolled systemic illness or medical condition: congestive heart failure, unstable angina, history of documented myocardial infarction within 6 months, uncontrolled hypertension and high risk uncontrollable arrhythmias; Obvious neurological or mental abnormalities including mental disorder, epileptic dementia, which affect compliance; Uncontrolled acute infections; Uncontrolled peptic ulcer, diabetes or other contraindication for corticosteroid therapy Inability to take or absorb oral medicine Concurrent administration of any other investigational drug, or have been enrolled in other clinical trial with investigational drug treatment within the 30 days of start of study treatment Presence of neuropathy ≥grade 1 according to NCI-CTCAE V4.0 Hypersensitivity or known or suspicious allergic to any of the study drugs Pregnant or lactated women Unsuitable for the study or other chemotherapy determined by investigator
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yunpeng Liu, MD., PhD
Organizational Affiliation
China Medical University, China
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Xiujuan Qu, MD.,PhD.
Organizational Affiliation
China Medical University, China
Official's Role
Principal Investigator
Facility Information:
Facility Name
The Fourth Hospital of Anshan
City
Anshan
State/Province
Liaoning
Country
China
Facility Name
The First Hospital of Dalian Medical University
City
Dalian
State/Province
Liaoning
Country
China
Facility Name
The Second Hospital of Dalian Medical University
City
Dalian
State/Province
Liaoning
Country
China
Facility Name
The First Hospital of Liaoning Medical University
City
Jinzhou
State/Province
Liaoning
Country
China
Facility Name
The First Hospital of China Medical University
City
Shenyang
State/Province
Liaoning
ZIP/Postal Code
110001
Country
China
Facility Name
Liaoning Tumor Hospital
City
Shenyang
State/Province
Liaoning
Country
China
Facility Name
Shengjing Hospital of China Medical University
City
Shenyang
State/Province
Liaoning
Country
China

12. IPD Sharing Statement

Learn more about this trial

A Phase 2 Trial of Optimizing Platinum-Based Chemotherapy Based on ERCC1 Expression as First-Line Treatment in Patients With Locally Advanced or Metastatic Gastric Cancer

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