Using Genetic Polymorphisms to Predict the Efficacy and Toxicity - A Gastric Adenocarcinoma Study

This study is currently recruiting participants. (see Contacts and Locations)
Verified October 2013 by National Health Research Institutes, Taiwan
Sponsor:
Collaborators:
Taipei Veterans General Hospital, Taiwan
Tri-Service General Hospital
Mackay Memorial Hospital
National Cheng-Kung University Hospital
Information provided by (Responsible Party):
National Health Research Institutes, Taiwan
ClinicalTrials.gov Identifier:
NCT01558011
First received: March 5, 2012
Last updated: October 28, 2013
Last verified: October 2013
  Purpose

This is an open-label, non-comparative phase II study of sequential capecitabine plus oxaliplatin followed by docetaxel plus capecitabine in patients with unresectable gastric adenocarcinoma.


Condition Intervention Phase
Gastric Adenocarcinoma
Drug: Capecitabine, Oxaliplatin, Docetaxel
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Using Genetic Polymorphisms of Drug Metabolism and Immunohistochemical Stain to Predict the Efficacy and Toxicity in Patients With Gastric Adenocarcinoma - A Phase II Study

Resource links provided by NLM:


Further study details as provided by National Health Research Institutes, Taiwan:

Primary Outcome Measures:
  • Objective response rate [ Time Frame: Every 6 weeks ] [ Designated as safety issue: Yes ]
    Tumor responses in measurable lesions are to be evaluated by the tumor response guidelines validated by the Response Evaluation Criteria in Solid Tumors (RECIST) Group . The new version 1.1 was published in 2009.


Secondary Outcome Measures:
  • Progression-free survival [ Time Frame: Every 6 weeks ] [ Designated as safety issue: Yes ]
    Be calculated as the duration between the first date of randomization and the date of disease recurrence or progression according to RECIST (failed), taking the status of tumor at the treatment has been completed as the reference, or death (failed), or the date of withdrawal (last contact date, censored), or the scheduled data analysis date (censored).


Estimated Enrollment: 100
Study Start Date: March 2012
Estimated Study Completion Date: December 2016
Estimated Primary Completion Date: December 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: chemotherapy

Chemotherapy:

Drug: Capecitabine, Oxaliplatin, Docetaxel Dosing Regimena: total of 6 cycles of modified XELOX regimen repeats every 2 weeks, and followed by 4 cycles of TX repeats every 3 weeks. After 10 cycles of treatment, patients may continue to treat with either of the regimen, preferably the one having the best efficacy.

Drug: Capecitabine, Oxaliplatin, Docetaxel

Capecitabine: 500 mg film coated tablets; Oxaliplatin: 50 mg/ 10 ml; Docetaxel: 20 mg / 0.5ml vial.

Dosing Regimena: total of 6 cycles of modified XELOX regimen repeats every 2 weeks, and followed by 4 cycles of TX repeats every 3 weeks. After 10 cycles of treatment, patients may continue to treat with either of the regimen, preferably the one having the best efficacy.

Other Names:
  • Capecitabine (Xeloda○R), company: Roche
  • Oxaliplatin (Eloxatin○R, company: Sanofi-Avantis
  • Docetaxel (Taxotere○R, company: Sanofi-Avantis

Detailed Description:

There are two primary objectives in different steps. In the first step, the primary objective of this study is to investigate the objective response rate in patients receiving sequential capecitabine plus oxaliplatin followed by docetaxel plus capecitabine in patients with unresectable gastric adenocarcinoma.

In the second step, the primary objective of this study is to screen the predictive biomarkers of three different chemotherapeutic drugs and also investigate the objective response rate in patients receiving sequential capecitabine plus oxaliplatin followed by docetaxel plus capecitabine in patients with unresectable gastric adenocarcinoma.

  Eligibility

Ages Eligible for Study:   20 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Pathologically confirmed gastric adenocarcinoma.
  • At least one measurable lesion in a non-irradiated area.
  • No prior exposure to systemic chemotherapy for advanced gastric cancer.
  • For those have adjuvant chemotherapy after a curative gastrectomy, the last dosing of previous adjuvant chemotherapy should be at least 6 months before the start of this treatment.
  • Age > 20 years old.
  • ECOG Performance Status 2.
  • Life expectancy greater than 12 weeks.
  • Adequate bone marrow function :absolutely neutrophil count 1.5 x 109/L or WBC 4 x 109/L; Hemoglobin > 9 g/dl;platelet count 100 x 109/L.
  • Adequate liver function : ALT & AST 2.5 x ULN if without liver metastasis or 5 x ULN if with hepatic metastasis. Alkaline phosphatase 2.5 x ULN if without liver metastasis or 5 x ULN, if with hepatic and bone metastasis. Bilirubin < 2 x ULN
  • Adequate renal function :Creatinine < 1.5 x ULN.
  • Patients must be accessible for treatment and follow-up in the participating centers.

Exclusion Criteria:

  • Patient who are receiving concurrent radiotherapy, chemotherapy or other experimental therapy.(Previous radiotherapy is allowable if the last dose was given more than 2 weeks before the protocol treatment).
  • Major surgery within two weeks prior to entering the study.
  • Patients with CNS metastasis, including clinical suspicion.
  • Patients who are under active or uncontrolled infections.
  • Patients who had cardiac arrhythmia or myocardial infarction history 6 months before entry.
  • Patients with clinically detectable peripheral neuropathy > 2 on the CTC criteria
  • Patients with concomitant illness that might be aggravated by chemotherapy.
  • Patients who are pregnant or with breast feeding.
  • Other concomitant or previously malignancy within 5 yrs except for in situ cervix cancer or squamous cell carcinoma of the skin treated by surgery only.
  • Patients with hypersensitivity to any component of the chemotherapeutic regimen.
  • Mental status is not fit for clinical trial
  • Can not take study medication orally
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01558011

Contacts
Contact: Ming Hu Chen, MD +886-2-28712121 ext 2792 mhchen9@vghtpe.gov.tw
Contact: Yung Hs Chen, MSN +886-37-246166 ext 35119 yhchin@nhri.org.tw

Locations
Taiwan
National Health Research Institutes Recruiting
Zhunan, Miaoli, Taiwan, 350
Contact: Yee Chao, PhD    +886-2-28757270 ext 7618    ychao@vghtpe.gov.tw   
Contact: Tsang Wu Liu, MD    +886-37-246166 ext 35120    walter@nhri.org.tw   
Principal Investigator: Woei Ya Kao, MD         
Principal Investigator: Chia Ju Yen, MD         
Principal Investigator: Ruey Ku Hsieh, MD         
Sponsors and Collaborators
National Health Research Institutes, Taiwan
Taipei Veterans General Hospital, Taiwan
Tri-Service General Hospital
Mackay Memorial Hospital
National Cheng-Kung University Hospital
  More Information

No publications provided

Responsible Party: National Health Research Institutes, Taiwan
ClinicalTrials.gov Identifier: NCT01558011     History of Changes
Other Study ID Numbers: T3211, 100CT202
Study First Received: March 5, 2012
Last Updated: October 28, 2013
Health Authority: Taiwan: Institutional Review Board

Keywords provided by National Health Research Institutes, Taiwan:
gastric adenocarcinoma
Capecitabine and oxaliplatin (XELOX)
Docetaxel and capecitabine (TX)
Using genetic polymorphisms
drug metabolism and immunohistochemical stain
predict the efficacy

Additional relevant MeSH terms:
Adenocarcinoma
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Docetaxel
Capecitabine
Oxaliplatin
Fluorouracil
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Antimetabolites, Antineoplastic
Antimetabolites
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on September 22, 2014