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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

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ClinicalTrials.gov Identifier: NCT01963702
Recruitment Status : Unknown
Verified October 2013 by Xiaodong Zhu, Fudan University.
Recruitment status was:  Recruiting
First Posted : October 16, 2013
Last Update Posted : October 16, 2013
Sponsor:
Information provided by (Responsible Party):
Xiaodong Zhu, Fudan University

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.

Condition or disease Intervention/treatment Phase
Gastric Cancer Drug: Docetaxol Drug: Oxaliplatin Drug: Capecitabine Phase 2

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  (Clinical Trial)
Estimated Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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 Start Date : August 2012
Estimated Primary Completion Date : December 2013
Estimated Study Completion Date : December 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Stomach Cancer
U.S. FDA Resources

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: Docetaxol Drug: Capecitabine
Other Name: xeloda
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 Name: xeloda



Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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


Other Outcome Measures:
  1. 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



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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

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): NCT01963702


Contacts
Contact: xiaodong Zhu, M.D +862164175590 ext 5000 xddr001@163.com

Locations
China, Shanghai
Fudan University Cancer Hospital Recruiting
Shanghai, Shanghai, China, 200032
Contact: xiaodong Zhu, M.D    +862164175590 ext 5000    xddr001@163.com   
Sub-Investigator: xiaodong Zhu, M.D         
Sponsors and Collaborators
Fudan University
Investigators
Principal Investigator: Jin Li, M.D / Ph.D Fudan University

Responsible Party: Xiaodong Zhu, associate professor, Fudan University
ClinicalTrials.gov Identifier: NCT01963702     History of Changes
Other Study ID Numbers: FDZL-TXELOX
First Posted: October 16, 2013    Key Record Dates
Last Update Posted: October 16, 2013
Last Verified: October 2013

Keywords provided by Xiaodong Zhu, Fudan University:
predictive factor
response
gastric neoplasm
oxaliplatin
docetaxol
capecitabine

Additional relevant MeSH terms:
Stomach Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Stomach Diseases
Capecitabine
Oxaliplatin
Docetaxel
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators