A Phase II Trial of Exploring the Predictive Factors of TX and XELOX Regimen in the First Line Treatment of MGC
Conditions
Gastric Cancer
Conditions: official terms
Stomach Neoplasms
Conditions: Keywords
predictive factor, response, gastric neoplasm, oxaliplatin, docetaxol, capecitabine
Study Type
Interventional
Study Phase
Phase 2
Study Design
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment
Intervention
Name: Docetaxol Type: Drug
Name: Oxaliplatin Type: Drug
Name: Capecitabine Type: Drug
Overall Status
Recruiting
Summary
Platinum, fluorouracil and taxane based regimen are all acceptable in the first line treatment of metastatic gastric cancer. The TX and XELOX regimen are two common regimen used in MGC. whichever regimen is used, the average response rate is less than 50%. So a rather part of patients can't get benefit from the treatment. It is urgent to find out the predictive factors of these regimens in order to get a higher response and better survival outcome.
Detailed Description
Patients with MGC will be treated with TX or XELOX regimen. Before treatment, 14 days after treatment and after progression, the blood sample will be collected. Primary tumor blocks will also of collected. These samples will be used to detect predictive factors of the two types first line therapy.
Criteria for eligibility
Healthy Volunteers: No
Maximum Age: 75 Years
Minimum Age: 18 Years
Gender: Both
Criteria: Inclusion Criteria:

- Chemo-naive patients with metastatic, unresectable, histologically confirmed gastric or Gastroesophageal adenocarcinoma; Patients who received adjuvant chemotherapy, the duration from the last therapy to relapse at least longer than 6 months

- Patient must have at least one measurable lesions (RECIST 1.1)

- 18 Years to 75 years

- Written informed consent obtained

- Eastern Cooperative Oncology Group (ECOG) performance status 0-1

- Patients must have adequate organ and marrow function as defined below:

- neutrophilicgranulocyte greater than/equal to 1,500/mm3;

- platelets greater than/equal to 90,000/ mm3;

- hemoglobin greater than/equal to 9 gm/dL (may be transfused to maintain or exceed this level);

- total bilirubin less than/equal to 1.5 within institutional upper limit of normal (IULN);

- Aspartate Transaminase (AST,SGOT)/Alanine transaminase (ALT,SGPT) less than/equal to 2.5 times IULN

- serum creatinine less than/equal to 1.5 x IULN.

Exclusion Criteria:

- Active clinically serious infections (> grade 2 NCI-CTC version 3.0, National Cancer Institute-Common Terminology Criteria for Adverse Events)

- Symptomatic metastatic brain or meningeal tumors

- History of organ allograft

- Patients undergoing renal dialysis

- chronic inflammatory bowel disease; ileus; genetic fructose intolerance

- Patients who received adjuvant chemotherapy and the duration from the last therapy less than 6 months

- Receive previously radiotherapy in measurable regions

- Pregnancy or lactating status

- Concurrent malignancy other than nonmelanoma skin cancer, or in situ cervix carcinoma

- Clinically relevant coronary artery disease or history of a myocardial infarction within the last 12 months

- Acute or subacute intestinal occlusion or history of the inflammatory bowel disease

- Any factors that influence the usage of oral administration
Location
Fudan University Cancer Hospital
Shanghai, Shanghai, China
Status: Recruiting
Contact: xiaodong Zhu, M.D - +862164175590 - xddr001@163.com
Start Date
August 2012
Completion Date
December 2014
Sponsors
Fudan University
Source
Fudan University
Record processing date
ClinicalTrials.gov processed this data on July 28, 2015
ClinicalTrials.gov page