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XELOX With Capecitabine Maintenance or XELOX in Elderly Metastatic Adenocarcinoma of Stomach

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01798251
Recruitment Status : Unknown
Verified May 2013 by BAI Yuxian, Harbin Medical University.
Recruitment status was:  Recruiting
First Posted : February 25, 2013
Last Update Posted : May 6, 2013
Sponsor:
Information provided by (Responsible Party):
BAI Yuxian, Harbin Medical University

Study Description
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Brief Summary:
To confirm the efficacy and safety of XELOX with capecitabine maintenance in treatment of elderly advanced gastric cancer (AGC) by comparing it with that of XELOX regimen.

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

Detailed Description:
To investigate whether XELOX with capecitabine maintenance treatment as 1st line treatment in the elderly advanced gastric cancer is as effective and safe as XELOX regimen.
Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Randomized Single Center Phase II Study Comparing XELOX With Capecitabine Maintenance or XELOX Treatment in Elderly Metastatic Adenocarcinoma of Stomach
Study Start Date : December 2012
Estimated Primary Completion Date : December 2014
Estimated Study Completion Date : December 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Stomach Cancer

Arms and Interventions
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Arm Intervention/treatment
Experimental: XELOX-X

XELOX: Oxaliplatin: 100mg/m2 d1 Intravenous infusion, every 3 weeks. Capecitabine: 850mg/m^2 bid, days 1-14, every 3 weeks and maximum 4 cycles, or progression/intolerance.

X Maintenance: Capecitabine 850mg/m^2 bid, days 1-14, every 3 weeks after 4 cycles XELOX regimen, until progression/intolerance.

 Drug: Oxaliplatin
Oxaliplatin 100mg/m2 d1 Intravenous infusion every 3 weeks
Other Name: L-OHP

Drug: Capecitabine
capecitabine 850mg/m2 bid, d1-14, every 3 weeks
Other Name: XELODA
Active Comparator: XELOX
XELOX: Oxaliplatin 100mg/m2 d1 Intravenous infusion, every 3 weeks. Capecitabine 850mg/m^2 bid, days 1-14, every 3 weeks, until progression/intolerance.
 Drug: Oxaliplatin
Oxaliplatin 100mg/m2 d1 Intravenous infusion every 3 weeks
Other Name: L-OHP

Drug: Capecitabine
capecitabine 850mg/m2 bid, d1-14, every 3 weeks
Other Name: XELODA


Outcome Measures
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Primary Outcome Measures :
  1. Progression Free Survival (PFS) [ Time Frame: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 12 months ]

Secondary Outcome Measures :
  1. overall survival (OS) [ Time Frame: from the date of randomization until death from any cause or up to 1 year ]
  2. Response Rate (RR) [ Time Frame: evaluate every 6 weeks after the date of randomization until diease progress or up to 12 weeks ]
  3. adverse events (AE) [ Time Frame: from date of randomization to 28 days after the last chemo dosage ]

Other Outcome Measures:
  1. health-related quality of life (HRQOL) [ Time Frame: evaluate every 6 weeks from the date of randomization until 28 days after the last chemo dosage ]
  2. excision repair cross-complementing 1(ERCC1) expression [ Time Frame: assays messager ribonucleic acid (mRNA) of ERCC1 expression in tumor tissue after randomization and before the first treatment ]
    quantitative real-time reverse transcriptase polymerase chain reaction (PCR) assays were performed to determine ERCC1 mRNA expression in tumor tissue.

  3. K-ras gene type [ Time Frame: assess after randomization and before the first treatment ]
    Genomic Deoxyribonucleic acid (DNA) is extracted from tumor tissue, direct sequencing technique is used to test K-ras gene type(mutation or wild).


Eligibility Criteria
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Ages Eligible for Study:   65 Years and older   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Ages Eligible for Study: 65 Years or older
  • Genders Eligible for Study: Both
  • The Eastern Cooperative Oncology Group (ECOG) status ≤ 2
  • Histologically confirmed gastric adenocarcinoma(including LAUREN type).
  • Measurable disease(according to the Response Evaluation Criteria in Solid Tumors (RECIST) criteria 1.1).
  • chemotherapy naive after recurrence or metastasis. Previous neo-adjuvant or adjuvant treatment for gastric cancer, if applicable, more than 6 months.
  • Hb > 90g/L, neutrophil count > or = 1.5*10^9/L, platelet > or = 100*10^9/L, alanine transaminase (ALT) and aspartate aminotransferase (AST) < or = 2.5 times upper limit of nominal (ULN), alkaline phosphatase (ALP) < or = 2.5 times ULN, total bilirubin (TBIL) < 1.5 times ULN, serum albumin level > or = 30g/L, serum creatinine < 1 times ULN.
  • No serious concomitant diseases which could lead to death within 5 years. At least 5 years from the last Biological/Immunotherapy/Hormone treatment for Malignancy excluding gastric cancer.
  • Able to accept oral medication
  • Compliance with protocol

Exclusion Criteria:

  • Had received cytotoxic chemotherapy, radiotherapy or immunotherapy for this gastric cancer, excluding Corticosteroids.
  • Other previous malignancy within 5 year, except curative skin cancer or carcinoma in situ of uterine cervix.
  • Uncontrolled epilepsy, central nervous system disorders, or a history of mental disorders.
  • clinically significant(i.e. active)cardiac disease e.g. symptomatic coronary artery disease, New York Heart Association (NYHA) II or more serious congestive heart failure or severe requiring medication intervention arrhythmia, or history of myocardial infarction within the last 12 months.
  • Upper gastrointestinal obstruction or physiological dysfunction or suffering from malabsorption syndrome, which could affect the absorption of capecitabine.
  • Organ transplantation requires immunosuppressive treatment.
  • Severe uncontrolled recurrent infections, or Other serious uncontrolled concomitant diseases.
  • Moderate or severe renal impairment(creatinine clearance (CCr) = or < 50 ml/min), or serum creatinine > ULN.
  • Known enzyme deficiency of dihydropyrimidine dehydrogenase(DPD).
  • Allergy to Oxaliplatin or any study medication ingredients.
Contacts and Locations
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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): NCT01798251


Contacts
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Contact: Yuxian BAI, PhD 86 451 86298265 bai_yuxian@126.com
Contact: Hong SUI, PhD 86 13936592698 doctorsui2003@126.com

Locations
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China, Heilongjiang
The tumor hospital of Harbin medical university Recruiting
Harbin, Heilongjiang, China, 150000
Contact: Yuxian BAI, PhD    86 451 86298265    bai_yuxian@126.com   
Contact: Hong SUI, PhD    86 13936592698    doctorsui2003@126.com   
Principal Investigator: Yuxian BAI, PhD         
Sub-Investigator: Hong SUI, PhD         
Sponsors and Collaborators
Harbin Medical University
Investigators
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Principal Investigator: Yuxian BAI, PhD The tumor hospital of Harbin medical university
More Information
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Responsible Party: BAI Yuxian, Professor, Harbin Medical University
ClinicalTrials.gov Identifier: NCT01798251    
Other Study ID Numbers: CGOG20120101009
First Posted: February 25, 2013    Key Record Dates
Last Update Posted: May 6, 2013
Last Verified: May 2013
Keywords provided by BAI Yuxian, Harbin Medical University:
Elderly Gastric Cancer
Capecitabine Maintenance
Additional relevant MeSH terms:
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Adenocarcinoma
Stomach Neoplasms
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
 Digestive System Diseases
Gastrointestinal Diseases
Stomach Diseases
Capecitabine
Oxaliplatin
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents