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Using Genetic Polymorphisms of Drug Metabolism and Immunohistochemical Stain to Predict the Efficacy and Toxicity in Patients With Gastric Adenocarcinoma - A Phase II Study


Phase 2
20 Years
N/A
Open (Enrolling)
Both
Gastric Adenocarcinoma

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Trial Information

Using Genetic Polymorphisms of Drug Metabolism and Immunohistochemical Stain to Predict the Efficacy and Toxicity in Patients With Gastric Adenocarcinoma - A Phase II Study


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.


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

Type of Study:

Interventional

Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Objective response rate

Outcome 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.

Outcome Time Frame:

Every 6 weeks

Safety Issue:

Yes

Authority:

Taiwan: Institutional Review Board

Study ID:

T3211

NCT ID:

NCT01558011

Start Date:

March 2012

Completion Date:

December 2016

Related Keywords:

  • Gastric Adenocarcinoma
  • gastric adenocarcinoma
  • Capecitabine and oxaliplatin (XELOX)
  • Docetaxel and capecitabine (TX)
  • Using genetic polymorphisms
  • drug metabolism and immunohistochemical stain
  • predict the efficacy
  • Adenocarcinoma
  • Adenocarcinoma, Mucinous
  • Stomach Neoplasms

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