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A Phase II Trial of Exploring the Predictive Factors of TX and XELOX Regimen in the First Line Treatment of MGC

Primary Purpose

Gastric Cancer

Status
Unknown status
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
Docetaxol
Oxaliplatin
Capecitabine
Sponsored by
Fudan University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Gastric Cancer focused on measuring predictive factor, response, gastric neoplasm, oxaliplatin, docetaxol, capecitabine

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Chemo-naive patients with metastatic, unresectable, histologically confirmed gastric or Gastroesophageal adenocarcinoma; Patients who received adjuvant chemotherapy, the duration from the last therapy to relapse at least longer than 6 months
  • Patient must have at least one measurable lesions (RECIST 1.1)
  • 18 Years to 75 years
  • Written informed consent obtained
  • Eastern Cooperative Oncology Group (ECOG) performance status 0-1
  • Patients must have adequate organ and marrow function as defined below:
  • neutrophilicgranulocyte greater than/equal to 1,500/mm3;
  • platelets greater than/equal to 90,000/ mm3;
  • hemoglobin greater than/equal to 9 gm/dL (may be transfused to maintain or exceed this level);
  • total bilirubin less than/equal to 1.5 within institutional upper limit of normal (IULN);
  • Aspartate Transaminase (AST,SGOT)/Alanine transaminase (ALT,SGPT) less than/equal to 2.5 times IULN
  • serum creatinine less than/equal to 1.5 x IULN.

Exclusion Criteria:

  • Active clinically serious infections (> grade 2 NCI-CTC version 3.0, National Cancer Institute-Common Terminology Criteria for Adverse Events)
  • Symptomatic metastatic brain or meningeal tumors
  • History of organ allograft
  • Patients undergoing renal dialysis
  • chronic inflammatory bowel disease; ileus; genetic fructose intolerance
  • Patients who received adjuvant chemotherapy and the duration from the last therapy less than 6 months
  • Receive previously radiotherapy in measurable regions
  • Pregnancy or lactating status
  • Concurrent malignancy other than nonmelanoma skin cancer, or in situ cervix carcinoma
  • Clinically relevant coronary artery disease or history of a myocardial infarction within the last 12 months
  • Acute or subacute intestinal occlusion or history of the inflammatory bowel disease
  • Any factors that influence the usage of oral administration

Sites / Locations

  • Fudan University Cancer HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Docetaxol ＆Capecitabine (TX)

Oxaliplatin ＆Capecitabine (XELOX)

Arm Description

Docetaxol: 75 mg/m2 d1, (From MAY 15th 2013, the dose was reduced to 60mg/m2 for high incidence of G3/4 myelosuppression after approved by institute Ethics Committee) ; Capecitabine 1000 mg/m2 bid ×14d; Repeat every 3 weeks, until disease progression or intolerable toxicity or patients withdrawal of consent,or total 8 cycles

Oxaliplatin: 130 mg/m2 d1; Capecitabine 1000 mg/m2 bid ×14d; Repeat every 3 weeks, until disease progression or intolerable toxicity or patients withdrawal of consent,or total 8 cycles

Outcomes

Primary Outcome Measures

objective response
RECIST 1.1 (Response Evaluation Criteria in Solid Tumors) will be used to evaluate the response of each patient every 6 weeks. The main purpose of this study is to search for the biomarkers which will predict the response of patients with MGC received TX or XELOX regimen as first line therapy

Secondary Outcome Measures

progression free survival (PFS)
PFS is defined as from the date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 60 months

Full Information

First Posted
October 9, 2013
Last Updated
October 12, 2013
Sponsor
Fudan University
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1. Study Identification

Unique Protocol Identification Number
NCT01963702
Brief Title
A Phase II Trial of Exploring the Predictive Factors of TX and XELOX Regimen in the First Line Treatment of MGC
Official Title
Phase II Trial of Exploring the Predictive Factors of Docetaxol Plus Capecitabine(TX) Regimen and Oxaliplatin Plus Capecitabine (XELOX) Regimen in the First Line Treatment of Patients With Metastatic Gastric Cancer (MGC)
Study Type
Interventional

2. Study Status

Record Verification Date
October 2013
Overall Recruitment Status
Unknown status
Study Start Date
August 2012 (undefined)
Primary Completion Date
December 2013 (Anticipated)
Study Completion Date
December 2014 (Anticipated)

3. Sponsor/Collaborators

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

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
Platinum, fluorouracil and taxane based regimen are all acceptable in the first line treatment of metastatic gastric cancer. The TX and XELOX regimen are two common regimen used in MGC. whichever regimen is used, the average response rate is less than 50%. So a rather part of patients can't get benefit from the treatment. It is urgent to find out the predictive factors of these regimens in order to get a higher response and better survival outcome.
Detailed Description
Patients with MGC will be treated with TX or XELOX regimen. Before treatment, 14 days after treatment and after progression, the blood sample will be collected. Primary tumor blocks will also of collected. These samples will be used to detect predictive factors of the two types first line therapy.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gastric Cancer
Keywords
predictive factor, response, gastric neoplasm, oxaliplatin, docetaxol, capecitabine

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
120 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Docetaxol ＆Capecitabine (TX)
Arm Type
Experimental
Arm Description
Docetaxol: 75 mg/m2 d1, (From MAY 15th 2013, the dose was reduced to 60mg/m2 for high incidence of G3/4 myelosuppression after approved by institute Ethics Committee) ; Capecitabine 1000 mg/m2 bid ×14d; Repeat every 3 weeks, until disease progression or intolerable toxicity or patients withdrawal of consent,or total 8 cycles
Arm Title
Oxaliplatin ＆Capecitabine (XELOX)
Arm Type
Active Comparator
Arm Description
Oxaliplatin: 130 mg/m2 d1; Capecitabine 1000 mg/m2 bid ×14d; Repeat every 3 weeks, until disease progression or intolerable toxicity or patients withdrawal of consent,or total 8 cycles
Intervention Type
Drug
Intervention Name(s)
Docetaxol
Intervention Type
Drug
Intervention Name(s)
Oxaliplatin
Intervention Type
Drug
Intervention Name(s)
Capecitabine
Other Intervention Name(s)
xeloda
Primary Outcome Measure Information:
Title
objective response
Description
RECIST 1.1 (Response Evaluation Criteria in Solid Tumors) will be used to evaluate the response of each patient every 6 weeks. The main purpose of this study is to search for the biomarkers which will predict the response of patients with MGC received TX or XELOX regimen as first line therapy
Time Frame
6 weeks
Secondary Outcome Measure Information:
Title
progression free survival (PFS)
Description
PFS is defined as from the date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 60 months
Time Frame
From randomization until first documented progression or date of death from any cause, whichever came first (up to 60 months)
Other Pre-specified Outcome Measures:
Title
overall survival(OS)
Description
OS is defined as from the date of randomization until the date of death from any cause, assessed up to 60 months
Time Frame
from the date of randomization until the date of death from any cause, assessed up to 60 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Chemo-naive patients with metastatic, unresectable, histologically confirmed gastric or Gastroesophageal adenocarcinoma; Patients who received adjuvant chemotherapy, the duration from the last therapy to relapse at least longer than 6 months Patient must have at least one measurable lesions (RECIST 1.1) 18 Years to 75 years Written informed consent obtained Eastern Cooperative Oncology Group (ECOG) performance status 0-1 Patients must have adequate organ and marrow function as defined below: neutrophilicgranulocyte greater than/equal to 1,500/mm3; platelets greater than/equal to 90,000/ mm3; hemoglobin greater than/equal to 9 gm/dL (may be transfused to maintain or exceed this level); total bilirubin less than/equal to 1.5 within institutional upper limit of normal (IULN); Aspartate Transaminase (AST,SGOT)/Alanine transaminase (ALT,SGPT) less than/equal to 2.5 times IULN serum creatinine less than/equal to 1.5 x IULN. Exclusion Criteria: Active clinically serious infections (> grade 2 NCI-CTC version 3.0, National Cancer Institute-Common Terminology Criteria for Adverse Events) Symptomatic metastatic brain or meningeal tumors History of organ allograft Patients undergoing renal dialysis chronic inflammatory bowel disease; ileus; genetic fructose intolerance Patients who received adjuvant chemotherapy and the duration from the last therapy less than 6 months Receive previously radiotherapy in measurable regions Pregnancy or lactating status Concurrent malignancy other than nonmelanoma skin cancer, or in situ cervix carcinoma Clinically relevant coronary artery disease or history of a myocardial infarction within the last 12 months Acute or subacute intestinal occlusion or history of the inflammatory bowel disease Any factors that influence the usage of oral administration
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
xiaodong Zhu, M.D
Phone
+862164175590
Ext
5000
Email
xddr001@163.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jin Li, M.D / Ph.D
Organizational Affiliation
Fudan University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Fudan University Cancer Hospital
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200032
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
xiaodong Zhu, M.D
Phone
+862164175590
Ext
5000
Email
xddr001@163.com
First Name & Middle Initial & Last Name & Degree
xiaodong Zhu, M.D

12. IPD Sharing Statement

Learn more about this trial

A Phase II Trial of Exploring the Predictive Factors of TX and XELOX Regimen in the First Line Treatment of MGC

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