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

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

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.

Study Overview

• Status: Unknown
• Conditions: Advanced Gastric Cancer
• Intervention / Treatment: Drug: capecitabine; Drug: cisplatin; Drug: Paclitaxel

• Study Type: Interventional
• Enrollment (Anticipated): 320
• Phase: Phase 3

Contacts and Locations

• Study Contact: Name: Zhihao Lu, MD; Phone Number: 86-10-88196561; Email: pppeirain@126.com
• Study Contact Backup: Name: Fu Chen, Bachelor; Phone Number: 86-10-88196561; Email: kimandking@163.com

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China, 100142
      • Recruiting
      • Department of GI Oncology, Peking University, School of Oncology
      • Contact: Zhihao Lu, MD; Phone Number: 86-10-88196561; Email: pppeirain@126.com
      • Principal Investigator: Shen Lin, MD

Participation Criteria

Eligibility Criteria

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

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Cisplatin plus capecitabine	Drug: capecitabine; Dosing schedule: 1000mg/m2 bid, days 1-14, every 3 weeks; Drug: cisplatin; 80mg/m2, day 1 of every 3 weeks
Experimental: Paclitaxel plus Capecitabine	Drug: capecitabine; Dosing schedule: 1000mg/m2 bid, days 1-14, every 3 weeks; Drug: Paclitaxel; 80mg/m2 infusion,d1,d8 every 3 weeks

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Progression free survival	3 year

Secondary Outcome Measures

Outcome Measure	Time Frame
Overall survival	5 year
Tumor response rate	1 year
Disease control rate	1 year
adverse evens	5 year

Collaborators and Investigators

• Sponsor: Peking University
• Collaborators: Roche Pharma AG
• Investigators: Principal Investigator: Lin Shen, MD, Peking University, School of Oncology, Department of GI oncology

Study record dates

Study Major Dates

• Study Start: November 1, 2009
• Primary Completion (Anticipated): August 1, 2015
• Study Completion (Anticipated): August 1, 2015

Study Registration Dates

• First Submitted: November 17, 2009
• First Submitted That Met QC Criteria: November 17, 2009
• First Posted (Estimate): November 18, 2009

Study Record Updates

• Last Update Posted (Estimate): May 19, 2015
• Last Update Submitted That Met QC Criteria: May 17, 2015
• Last Verified: May 1, 2015

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms by Histologic Type; Neoplasms; Carcinoma; Neoplasms, Glandular and Epithelial; Adenocarcinoma; Molecular Mechanisms of Pharmacological Action; Antimetabolites, Antineoplastic; Antimetabolites; Antineoplastic Agents; Tubulin Modulators; Antimitotic Agents; Mitosis Modulators; Antineoplastic Agents, Phytogenic; Paclitaxel; Cisplatin; Capecitabine
• Other Study ID Numbers: PAC-C; ML22697

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No