Sorafenib as a Second Line Treatment in Patients With Advanced or Metastatic Gastric Cancer

This study has been terminated.
(low response rate, no evidence of PFS or OS improved.)
Sponsor:
Information provided by:
Fudan University
ClinicalTrials.gov Identifier:
NCT00595985
First received: January 7, 2008
Last updated: July 6, 2009
Last verified: July 2009
  Purpose

The purpose of this study is to evaluate the efficacy and tolerability of sorafenib as second line treatment in patients with Advanced or Metastatic Gastric Cancer (A/MGC).


Condition Intervention Phase
Gastric Cancer
Drug: sorafenib
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Phase II Trial of Sorafenib as Second Line Therapy in Patients With Advanced or Metastatic Gastric Cancer

Resource links provided by NLM:


Further study details as provided by Fudan University:

Primary Outcome Measures:
  • time to progression [ Time Frame: every six weeks ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • toxicity [ Time Frame: 6 weeks ] [ Designated as safety issue: Yes ]

Enrollment: 5
Study Start Date: July 2007
Estimated Study Completion Date: January 2009
Estimated Primary Completion Date: January 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: A
administer sorafenib 400mg bid until disease progression or intolerable toxicity or patients withdrawal of consent
Drug: sorafenib
sorafenib 400mg bid, and it should be continued until disease progression or intolerable toxicity or patients withdrawal of consent
Other Name: treatment group

Detailed Description:

Up to now, although FU based, cisplatin based and taxane based regimen, and ECF regimen have been suggested as the first line therapy for A/MGC by FDA, there is no standard regimen for patients with A/MGC as second line treatment. Based on the promising results of sorafenib in primary hepatic carcinoma and renal cancer, we design this clinical trial to evaluate the efficacy, time to progression and overall survival of sorafenib for A/MGC patients as a second line treatment.

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Histologically confirmed advanced or metastatic adenocarcinoma of the stomach
  • ECOG performance scale ≤ 2
  • At least one measurable lesion (larger than 10 mm in diameter by spiral CT scan)
  • Adequate hepatic, renal, heart, and hematologic functions:

    • platelets>80 × 109/L
    • neutrophil>2.0 × 109/L
    • serum creatinine ≤ 1.5mg/dl
    • total bilirubin within upper limit of normal(ULN)
    • serum transaminase ≤ 2.5 × the ULN

Exclusion Criteria:

  • Pregnant or lactating women
  • Concurrent cancer
  • History of other malignancies except cured basal cell carcinoma of skin and carcinoma in-situ of uterine cervix
  • Neuropathy, brain, or leptomeningeal involvement
  • Uncontrolled significant comorbid conditions and previous radiotherapy
  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: NCT00595985

Locations
China, Shanghai
Fudan University Cancer Hospital
ShangHai, Shanghai, China, 200032
Sponsors and Collaborators
Fudan University
Investigators
Principal Investigator: Jin Li, PhD, M.D. Fudan University
  More Information

No publications provided

Responsible Party: Base for drug clinical trials, Fudan University cancer hospital, Department of medical oncology, Cancer Hospital, Fuandan University
ClinicalTrials.gov Identifier: NCT00595985     History of Changes
Other Study ID Numbers: Sorafenib-MGC
Study First Received: January 7, 2008
Last Updated: July 6, 2009
Health Authority: China: Ethics Committee

Keywords provided by Fudan University:
Time to Progression
Toxicity
Overall survival
Response rate
Quality of live
Toxicities

Additional relevant MeSH terms:
Stomach Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Stomach Diseases
Sorafenib
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on October 01, 2014