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

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)

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.

Study Overview

• Status: Unknown
• Conditions: Gastric Cancer
• Intervention / Treatment: Drug: Oxaliplatin; Drug: Capecitabine; Drug: Docetaxol

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.

• Study Type: Interventional
• Enrollment (Anticipated): 120
• Phase: Phase 2

Contacts and Locations

Study Locations

• China
  • Shanghai
    • Shanghai, Shanghai, China, 200032
      • Recruiting
      • Fudan University Cancer Hospital
      • Contact: xiaodong Zhu, M.D; Phone Number: 5000 +862164175590; Email: xddr001@163.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Docetaxol ＆Capecitabine (TX); Docetaxol: 75 mg/m2 d1, (From MAY 15th 2013, the dose was reduced to 60mg/m2 for high incidence of G3/4 myelosuppression after approved by institute Ethics Committee) ; Capecitabine 1000 mg/m2 bid ×14d; Repeat every 3 weeks, until disease progression or intolerable toxicity or patients withdrawal of consent,or total 8 cycles	Drug: Capecitabine; Other Names: xeloda; Drug: Docetaxol
Active Comparator: Oxaliplatin ＆Capecitabine (XELOX); Oxaliplatin: 130 mg/m2 d1; Capecitabine 1000 mg/m2 bid ×14d; Repeat every 3 weeks, until disease progression or intolerable toxicity or patients withdrawal of consent,or total 8 cycles	Drug: Oxaliplatin; Drug: Capecitabine; Other Names: xeloda

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Fudan University
• Investigators: Principal Investigator: Jin Li, M.D / Ph.D, Fudan University

Study record dates

Study Major Dates

• Study Start: August 1, 2012
• Primary Completion (Anticipated): December 1, 2013
• Study Completion (Anticipated): December 1, 2014

Study Registration Dates

• First Submitted: October 9, 2013
• First Submitted That Met QC Criteria: October 12, 2013
• First Posted (Estimate): October 16, 2013

Study Record Updates

• Last Update Posted (Estimate): October 16, 2013
• Last Update Submitted That Met QC Criteria: October 12, 2013
• Last Verified: October 1, 2013

More Information

Terms related to this study

• Keywords: capecitabine; oxaliplatin; response; predictive factor; gastric neoplasm; docetaxol
• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Neoplasms by Site; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Stomach Diseases; Stomach Neoplasms; Molecular Mechanisms of Pharmacological Action; Antimetabolites, Antineoplastic; Antimetabolites; Antineoplastic Agents; Tubulin Modulators; Antimitotic Agents; Mitosis Modulators; Docetaxel; Capecitabine; Oxaliplatin
• Other Study ID Numbers: FDZL-TXELOX