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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified November 2009 by Peking University.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
Roche Pharma AG
Information provided by:
Peking University
ClinicalTrials.gov Identifier:
NCT01015339
First received: November 17, 2009
Last updated: December 28, 2009
Last verified: November 2009
  Purpose

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.


Condition Intervention Phase
Advanced Gastric Cancer
Drug: Paclitaxel
Drug: capecitabine
Drug: cisplatin
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Peking University:

Primary Outcome Measures:
  • Progression free survival [ Time Frame: 3 year ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Tumor response rate [ Time Frame: 1 year ] [ Designated as safety issue: No ]
  • Disease control rate [ Time Frame: 1 year ] [ Designated as safety issue: No ]
  • Overall survival [ Time Frame: 5 year ] [ Designated as safety issue: No ]
  • adverse evens [ Time Frame: 5 year ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 320
Study Start Date: November 2009
Estimated Study Completion Date: August 2012
Estimated Primary Completion Date: May 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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: Paclitaxel
80mg/m2 infusion,d1,d8 every 3 weeks
Drug: capecitabine
Dosing schedule: 1000mg/m2 bid, days 1-14, every 3 weeks

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01015339

Contacts
Contact: Zhihao Lu, MD 86-10-88196561 pppeirain@126.com
Contact: Fu Chen, Bachelor 86-10-88196561 kimandking@163.com

Locations
China, Beijing
Department of GI Oncology, Peking University, School of Oncology Recruiting
Beijing, Beijing, China, 100142
Contact: Zhihao Lu, MD    86-10-88196561    pppeirain@126.com   
Principal Investigator: Shen Lin, MD         
Sponsors and Collaborators
Peking University
Roche Pharma AG
Investigators
Principal Investigator: Lin Shen, MD Peking University, School of oncology, Department of GI oncology
  More Information

No publications provided

Responsible Party: Shen Lin, Organization: Peking University, School of Oncology, Department of GI oncology
ClinicalTrials.gov Identifier: NCT01015339     History of Changes
Other Study ID Numbers: PACLIC-C, ML22697
Study First Received: November 17, 2009
Last Updated: December 28, 2009
Health Authority: China: Food and Drug Administration

Additional relevant MeSH terms:
Adenocarcinoma
Stomach Neoplasms
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Gastrointestinal Diseases
Stomach Diseases
Paclitaxel
Capecitabine
Cisplatin
Fluorouracil
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Radiation-Sensitizing Agents
Antimetabolites, Antineoplastic
Antimetabolites
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on September 22, 2014