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

October 12, 2013 updated by: Xiaodong Zhu, Fudan University

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)

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

120

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: xiaodong Zhu, M.D
  • Phone Number: 5000 +862164175590
  • Email: xddr001@163.com

Study Locations

  • China
    • Shanghai
      • Shanghai, Shanghai, China, 200032
        • Recruiting
        • Fudan University Cancer Hospital
        • Contact:
          • xiaodong Zhu, M.D
          • Phone Number: 5000 +862164175590
          • Email: xddr001@163.com

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Docetaxol ＆Capecitabine (TX)
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
Drug: Capecitabine
Other Names:
  • xeloda
Drug: Docetaxol
Active Comparator: Oxaliplatin ＆Capecitabine (XELOX)
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
Drug: Oxaliplatin
Drug: Capecitabine
Other Names:
  • xeloda

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
objective response
Time Frame: 6 weeks
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
6 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
progression free survival (PFS)
Time Frame: From randomization until first documented progression or date of death from any cause, whichever came first (up to 60 months)
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
From randomization until first documented progression or date of death from any cause, whichever came first (up to 60 months)

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
overall survival(OS)
Time Frame: from the date of randomization until the date of death from any cause, assessed up to 60 months
OS is defined as from the date of randomization until the date of death from any cause, assessed up to 60 months
from the date of randomization until the date of death from any cause, assessed up to 60 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Fudan University

Investigators

  • Principal Investigator: Jin Li, M.D / Ph.D, Fudan University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2012

Primary Completion (Anticipated)

December 1, 2013

Study Completion (Anticipated)

December 1, 2014

Study Registration Dates

First Submitted

October 9, 2013

First Submitted That Met QC Criteria

October 12, 2013

First Posted (Estimate)

October 16, 2013

Study Record Updates

Last Update Posted (Estimate)

October 16, 2013

Last Update Submitted That Met QC Criteria

October 12, 2013

Last Verified

October 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • FDZL-TXELOX

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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