A Phase II Trial of Exploring the Predictive Factors of TX and XELOX Regimen in the First Line Treatment of MGC

Gastric Cancer Clinical Trial

Official title:

Phase II Trial of Exploring the Predictive Factors of Docetaxol Plus Capecitabine(TX) Regimen and Oxaliplatin Plus Capecitabine (XELOX) Regimen in the First Line Treatment of Patients With Metastatic Gastric Cancer (MGC)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01963702
• Other study ID #: FDZL-TXELOX
• Status: Recruiting
• Phase: Phase 2
• First received: October 9, 2013
• Last updated: October 12, 2013
• Start date: August 2012
• Est. completion date: December 2014

Study information

• Verified date: October 2013
• Source: Fudan University
• Contact: xiaodong Zhu, M.D
• Phone: +862164175590
• Email: xddr001[@]163.com
• Is FDA regulated: No
• Health authority: China:Ethic Committee
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 120
• Est. completion date: December 2014
• Est. primary completion date: December 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Gastric Cancer
• Stomach Neoplasms

Intervention

Drug:
• Docetaxol

• Oxaliplatin

• Capecitabine

Locations

Country	Name	City	State
China	Fudan University Cancer Hospital	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Fudan University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	overall survival(OS)	OS is defined as from the date of randomization until the date of death from any cause, assessed up to 60 months	from the date of randomization until the date of death from any cause, assessed up to 60 months	No
Primary	objective response	RECIST 1.1 (Response Evaluation Criteria in Solid Tumors) will be used to evaluate the response of each patient every 6 weeks. The main purpose of this study is to search for the biomarkers which will predict the response of patients with MGC received TX or XELOX regimen as first line therapy	6 weeks	No
Secondary	progression free survival (PFS)	PFS is defined as from the date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 60 months	From randomization until first documented progression or date of death from any cause, whichever came first (up to 60 months)	No