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Paclitaxel Plus Capecitabine With Capecitabine Maintenance Treatment in Metastatic Adenocarcinoma of the Stomach or Esophagogastric Junction

Primary Purpose

Advanced Gastric Cancer

Status
Unknown status
Phase
Phase 3
Locations
China
Study Type
Interventional
Intervention
Paclitaxel
capecitabine
capecitabine
cisplatin
Sponsored by
Peking University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Advanced Gastric Cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Having signed informed consent
  • Age≥ 18 years old
  • Histologically confirmed gastric adenocarcinoma
  • Unresectable recurrent or metastatic disease
  • Previous neo-adjuvant or adjuvant treatment for gastric cancer, if applicable, more than 6 months
  • Previous chemotherapy with capecitabine or cisplatin, if applicable, more than 12 months.
  • Measurable disease according to the RECIST criteria
  • Karnofsky performance status ≥60
  • Life expectancy of ≥2 month
  • No prior radiotherapy except radiotherapy at non-target lesion of the study more than 4 weeks
  • ALT and AST<2.5 times ULN (≤5 times ULN in patients with liver metastases)
  • Serum albumin level ≥3.0g/dL
  • Serum AKP < 2.5 times ULN
  • Serum creatinine <ULN, and CCr < 60ml/min
  • Bilirubin level < 1.5 ULN
  • WBC>3,000/mm3, absolute neutrophil count ≥2000/mm3, platelet>100,000/mm3, Hb>9g/dl

Exclusion Criteria:

  • Brain metastasis (known or suspected)
  • Previous systemic therapy for metastatic gastric cancer
  • Inability to take oral medication
  • Previous therapy targeting at angiogenesis or vasculogenesis pathway or other targeted therapy
  • Surgery (excluding diagnostic biopsy) within 4 weeks prior to study entry
  • Contraindications of nuclear magnetic resonance image such as fitment of cardiac pacemaker , nerve stimulator, or aneurysm clip, and metallic foreign body in eye ball and so on.
  • Allergic constitution or allergic history to protium biologic product or any investigating agents.
  • Severe heart disease or such history as recorded congestive heart failure, uncontrolled cardiac arrhythmia, angina pectoris needing medication, cardiac valve disease, severe abnormal ECG findings, cardiac infarction , or retractable hypertension.
  • Pregnancy or lactation period
  • Any investigational agent within the past 28 days
  • Other previous malignancy within 5 year, except non-melanoma skin cancer
  • Previous adjuvant therapy with capecitabine+platinum,
  • Pre-existing neuropathy>grade 1
  • Legal incapacity

Sites / Locations

  • Department of GI Oncology, Peking University, School of OncologyRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Cisplatin plus capecitabine

Paclitaxel plus Capecitabine

Arm Description

Outcomes

Primary Outcome Measures

Progression free survival

Secondary Outcome Measures

Tumor response rate
Disease control rate
Overall survival
adverse evens

Full Information

First Posted
November 17, 2009
Last Updated
May 17, 2015
Sponsor
Peking University
Collaborators
Roche Pharma AG
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1. Study Identification

Unique Protocol Identification Number
NCT01015339
Brief Title
Paclitaxel Plus Capecitabine With Capecitabine Maintenance Treatment in Metastatic Adenocarcinoma of the Stomach or Esophagogastric Junction
Official Title
A Randomized Multicenter Phase III Study Comparing Paclitaxel Plus Capecitabine With Capecitabine Maintenance Treatment or Cisplatin Plus Capecitabine in Metastatic Adenocarcinoma of the Stomach or Esophagogastric Junction
Study Type
Interventional

2. Study Status

Record Verification Date
May 2015
Overall Recruitment Status
Unknown status
Study Start Date
November 2009 (undefined)
Primary Completion Date
August 2015 (Anticipated)
Study Completion Date
August 2015 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Peking University
Collaborators
Roche Pharma AG

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The purpose of this study is to investigate whether Paclitaxel Plus Capecitabine With Capecitabine Maintenance Treatment as 1st line treatment in he advanced gastric cancer is effective and safe.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Advanced Gastric Cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
320 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Cisplatin plus capecitabine
Arm Type
Active Comparator
Arm Title
Paclitaxel plus Capecitabine
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Paclitaxel
Intervention Description
80mg/m2 infusion,d1,d8 every 3 weeks
Intervention Type
Drug
Intervention Name(s)
capecitabine
Intervention Description
Dosing schedule: 1000mg/m2 bid, days 1-14, every 3 weeks
Intervention Type
Drug
Intervention Name(s)
capecitabine
Intervention Description
Dosing schedule: 1000mg/m2 bid, days 1-14, every 3 weeks
Intervention Type
Drug
Intervention Name(s)
cisplatin
Intervention Description
80mg/m2, day 1 of every 3 weeks
Primary Outcome Measure Information:
Title
Progression free survival
Time Frame
3 year
Secondary Outcome Measure Information:
Title
Tumor response rate
Time Frame
1 year
Title
Disease control rate
Time Frame
1 year
Title
Overall survival
Time Frame
5 year
Title
adverse evens
Time Frame
5 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Having signed informed consent Age≥ 18 years old Histologically confirmed gastric adenocarcinoma Unresectable recurrent or metastatic disease Previous neo-adjuvant or adjuvant treatment for gastric cancer, if applicable, more than 6 months Previous chemotherapy with capecitabine or cisplatin, if applicable, more than 12 months. Measurable disease according to the RECIST criteria Karnofsky performance status ≥60 Life expectancy of ≥2 month No prior radiotherapy except radiotherapy at non-target lesion of the study more than 4 weeks ALT and AST<2.5 times ULN (≤5 times ULN in patients with liver metastases) Serum albumin level ≥3.0g/dL Serum AKP < 2.5 times ULN Serum creatinine <ULN, and CCr < 60ml/min Bilirubin level < 1.5 ULN WBC>3,000/mm3, absolute neutrophil count ≥2000/mm3, platelet>100,000/mm3, Hb>9g/dl Exclusion Criteria: Brain metastasis (known or suspected) Previous systemic therapy for metastatic gastric cancer Inability to take oral medication Previous therapy targeting at angiogenesis or vasculogenesis pathway or other targeted therapy Surgery (excluding diagnostic biopsy) within 4 weeks prior to study entry Contraindications of nuclear magnetic resonance image such as fitment of cardiac pacemaker , nerve stimulator, or aneurysm clip, and metallic foreign body in eye ball and so on. Allergic constitution or allergic history to protium biologic product or any investigating agents. Severe heart disease or such history as recorded congestive heart failure, uncontrolled cardiac arrhythmia, angina pectoris needing medication, cardiac valve disease, severe abnormal ECG findings, cardiac infarction , or retractable hypertension. Pregnancy or lactation period Any investigational agent within the past 28 days Other previous malignancy within 5 year, except non-melanoma skin cancer Previous adjuvant therapy with capecitabine+platinum, Pre-existing neuropathy>grade 1 Legal incapacity
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Zhihao Lu, MD
Phone
86-10-88196561
Email
pppeirain@126.com
First Name & Middle Initial & Last Name or Official Title & Degree
Fu Chen, Bachelor
Phone
86-10-88196561
Email
kimandking@163.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lin Shen, MD
Organizational Affiliation
Peking University, School of oncology, Department of GI oncology
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of GI Oncology, Peking University, School of Oncology
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100142
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Zhihao Lu, MD
Phone
86-10-88196561
Email
pppeirain@126.com
First Name & Middle Initial & Last Name & Degree
Shen Lin, MD

12. IPD Sharing Statement

Learn more about this trial

Paclitaxel Plus Capecitabine With Capecitabine Maintenance Treatment in Metastatic Adenocarcinoma of the Stomach or Esophagogastric Junction

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