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

Primary Purpose

Gastric Adenocarcinoma

Status
Terminated
Phase
Phase 2
Locations
Taiwan
Study Type
Interventional
Intervention
Capecitabine, Oxaliplatin, Docetaxel
Sponsored by
National Health Research Institutes, Taiwan
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Gastric Adenocarcinoma focused on measuring gastric adenocarcinoma, Capecitabine and oxaliplatin (XELOX), Docetaxel and capecitabine (TX), Using genetic polymorphisms, drug metabolism and immunohistochemical stain, predict the efficacy

Eligibility Criteria

20 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • National Health Research Institutes

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

chemotherapy

Arm Description

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.

Outcomes

Primary Outcome Measures

Objective response rate
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
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).

Full Information

First Posted
March 5, 2012
Last Updated
May 3, 2016
Sponsor
National Health Research Institutes, Taiwan
Collaborators
Taipei Veterans General Hospital, Taiwan, Tri-Service General Hospital, Mackay Memorial Hospital, National Cheng-Kung University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT01558011
Brief Title
Using Genetic Polymorphisms to Predict the Efficacy and Toxicity - A Gastric Adenocarcinoma Study
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
Study Type
Interventional

2. Study Status

Record Verification Date
October 2013
Overall Recruitment Status
Terminated
Why Stopped
The budget issues.
Study Start Date
March 2012 (undefined)
Primary Completion Date
October 2014 (Actual)
Study Completion Date
December 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
National Health Research Institutes, Taiwan
Collaborators
Taipei Veterans General Hospital, Taiwan, Tri-Service General Hospital, Mackay Memorial Hospital, National Cheng-Kung University Hospital

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gastric Adenocarcinoma
Keywords
gastric adenocarcinoma, Capecitabine and oxaliplatin (XELOX), Docetaxel and capecitabine (TX), Using genetic polymorphisms, drug metabolism and immunohistochemical stain, predict the efficacy

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
51 (Actual)

8. Arms, Groups, and Interventions

Arm Title
chemotherapy
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Capecitabine, Oxaliplatin, Docetaxel
Other Intervention Name(s)
Capecitabine (Xeloda○R), company: Roche, Oxaliplatin (Eloxatin○R, company: Sanofi-Avantis, Docetaxel (Taxotere○R, company: Sanofi-Avantis
Intervention Description
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.
Primary Outcome Measure Information:
Title
Objective response rate
Description
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.
Time Frame
Every 6 weeks
Secondary Outcome Measure Information:
Title
Progression-free survival
Description
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).
Time Frame
Every 6 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
Eligibility 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
Facility Information:
Facility Name
National Health Research Institutes
City
Zhunan
State/Province
Miaoli
ZIP/Postal Code
350
Country
Taiwan

12. IPD Sharing Statement

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

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