Clinical trial NCT01558011: 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
Overall status: TERMINATED
Phase: PHASE2
Conditions: Gastric Adenocarcinoma
Keywords: gastric adenocarcinoma
Capecitabine and oxaliplatin (XELOX)
Docetaxel and capecitabine (TX)
Using genetic polymorphisms
drug metabolism and immunohistochemical stain
predict the efficacy
Lead sponsor: National Health Research Institutes, Taiwan
Sponsor class: OTHER
Collaborators: name: Taipei Veterans General Hospital, Taiwan
name: Tri-Service General Hospital
name: Mackay Memorial Hospital
name: National Cheng-Kung University Hospital
First posted: 2012-03-20
Enrollment: 51
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Objective response rate
timeFrame: Every 6 weeks
Secondary outcomes:
measure: Progression-free survival
timeFrame: Every 6 weeks
Other outcomes:
Locations:
city: Zhunan
country: Taiwan
facility: National Health Research Institutes
state: Miaoli
Study officials:
References: