Taxanes or Platinum in Combination With Capecitabine Followed by Capecitabine Alone as First Line Treatment for Patients With Advanced Adenocarcinoma of Stomach or Esophagogastric Junction

The recruitment status of this study is unknown because the information has not been verified recently.
Verified November 2011 by The Affiliated Hospital of the Chinese Academy of Military Medical Sciences.
Recruitment status was  Recruiting
Sponsor:
Information provided by (Responsible Party):
Xu jianming, The Affiliated Hospital of the Chinese Academy of Military Medical Sciences
ClinicalTrials.gov Identifier:
NCT01468389
First received: November 4, 2011
Last updated: November 8, 2011
Last verified: November 2011
  Purpose

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


Condition Intervention Phase
Gastric Cancer
Drug: Capecitabine
Drug: capecitabine
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:Taxanes or Platinum in Combination With Capecitabine Followed by Capecitabine Alone vs.Taxanes or Platinum Combined With Capecitabine in Advanced Adenocarcinoma of the Stomach or Esophagogastric Junction.

Resource links provided by NLM:


Further study details as provided by The Affiliated Hospital of the Chinese Academy of Military Medical Sciences:

Primary Outcome Measures:
  • Progression free survival [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Tumor response rate [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
  • disease control rate [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
  • overall survival [ Time Frame: 3 year ] [ Designated as safety issue: Yes ]
  • adverse events [ Time Frame: 3 year ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 300
Study Start Date: November 2011
Estimated Study Completion Date: June 2013
Estimated Primary Completion Date: January 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Taxanes or Platinum in combination with Capecitabine
The patients will received chemotherapy combining capecitabine with platinum or taxanes until progression.
Drug: Capecitabine
900-1000mg/m2 bid, days 1-14, every 3 weeks
Experimental: chemotherapy followed by capecitabine alone
The patients who has received 4 cycle chemotherapy combining capecitabine with platinum or taxanes and the result was SD or CR or PR,will be given capecitabine alone until progression.
Drug: capecitabine
Dosing schedule: 900-1000mg/m2 bid, days 1-14, every 3 weeks Maintenance dosing schedule: 1000-1250mg/m2 bid, days 1-14, every 3 weeks

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Having signed informed consent
  2. Age≥ 18 years old
  3. Histologically confirmed gastric adenocarcinoma
  4. Unresectable recurrent or metastatic disease
  5. Previous neo-adjuvant or adjuvant treatment for gastric cancer, if applicable, more than 6 months
  6. Previous chemotherapy with oxaliplatin or cisplatin or paclitaxel or docetaxel, if applicable, more than 12 months.
  7. Measurable disease according to the RECIST criteria
  8. ECOG performance status ≤2
  9. Life expectancy of ≥3 month
  10. No prior radiotherapy except radiotherapy at non-target lesion of the study more than 4 weeks
  11. ALT and AST≤2.5 times ULN (≤5 times ULN in patients with liver metastases) Serum albumin level ≥3.0g/dL Serum creatinine ≤1.5ULN Bilirubin level ≤ 1.5 ULN WBC>3,000/mm3, absolute neutrophil count ≥1500/mm3, platelet>90,000/mm3, Hb>8g/dl

Exclusion Criteria:

  1. Brain metastasis (known or suspected)
  2. Previous systemic therapy for metastatic gastric cancer
  3. Inability to take oral medication
  4. Previous therapy targeting at angiogenesis or vasculogenesis pathway or other targeted therapy
  5. Surgery (excluding diagnostic biopsy) within 4 weeks prior to study entry
  6. Allergic constitution or allergic history to any investigating agents.
  7. 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.
  8. Pregnancy or lactation period
  9. Any investigational agent within the past 28 days
  10. Other previous malignancy within 5 year
  11. Pre-existing neuropathy>grade 1
  12. Legal incapacity
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01468389

Contacts
Contact: Xu jianming, M.D. 861051128358 jmxu2003@yahoo.com

Locations
China, Beijing
307 Hospital of PLA Recruiting
Beijing, Beijing, China
Contact: Xu jianming, M.D.    86-10-66947176    jmxu2003@yahoo.com   
Contact: Zhao chuanhua    86-10-66947179    chuanhuazhao@163.com   
Sponsors and Collaborators
The Affiliated Hospital of the Chinese Academy of Military Medical Sciences
Investigators
Principal Investigator: Xu jianming, M.D. The Affiliated Hospital of the Chinese Academy of Military Medical Science
Principal Investigator: XU jianming, M.D. The Affiliated Hospital of the Chinese Academy of Military Medical Science
  More Information

No publications provided

Responsible Party: Xu jianming, The Affiliated Hospital of the Chinese Academy of Military Medical Sciences
ClinicalTrials.gov Identifier: NCT01468389     History of Changes
Other Study ID Numbers: AGC001-307PLAH-XJM
Study First Received: November 4, 2011
Last Updated: November 8, 2011
Health Authority: China: Ethics Committee

Keywords provided by The Affiliated Hospital of the Chinese Academy of Military Medical Sciences:
Gastric Cancer
capecitabine
maintenance treatment

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
Taxane
Capecitabine
Fluorouracil
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on April 17, 2014