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A Study of Vinflunine in Patients With Gastric Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00359476
Recruitment Status : Terminated
First Posted : August 2, 2006
Last Update Posted : March 2, 2010
Sponsor:
Information provided by:
Bristol-Myers Squibb

Study Description
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Brief Summary:
The purpose of this study is to learn if vinflunine can shrink or slow the growth of cancer in patients with advanced or metastatic stomach cancer who have progressed on a prior treatment with a fluoropyrimidine or taxane-containing chemotherapy regimen. The safety of this treatment will also be studied.

Condition or disease Intervention/treatment Phase
Stomach Cancer Drug: Vinflunine Phase 2 Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 55 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Multicenter, Single-Arm, Phase II Study of Single-Agent Vinflunine in the Second-line Treatment of Patients With Gastric Cancer
Study Start Date : March 2007
Actual Primary Completion Date : October 2007
Actual Study Completion Date : November 2007

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Stomach Cancer

Arms and Interventions
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Arm Intervention/treatment
Experimental: 1 Drug: Vinflunine
solution for injection, IV, 280/320 mg/m2, every 3 wks, variable duration


Outcome Measures
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Primary Outcome Measures :
  1. The Response Rate (RR: Complete Response [CR]+Partial Response [PR], as defined by Response Evaluation Criteria in Solid Tumors [RECIST] [ Time Frame: throughout the study ]

Secondary Outcome Measures :
  1. Estimation of the progression free survival and overall survival [ Time Frame: At the end of the study ]
  2. The estimation of the disease control rate [ Time Frame: At the end of the study ]
  3. The time to response and the duration of response [ Time Frame: At the end of the study ]
  4. The evaluation of the safety profile of vinflunine [ Time Frame: At the end of the study ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients with locally advanced or metastatic gastric adenocarcinoma, including adenocarcinoma of the gastroesophageal junction who have progressed on a fluoropyrimidine or taxane-containing regimen in any combination in one prior first line treatment.
  • EGOC performance status of 0,1 or 2
  • Men and women, 18 years of age and older

Exclusion Criteria:

  • Patients having received more than one previous systemic chemotherapy regimen in any setting.
  • Major abdominal surgery within 2 months or any other surgery under general anesthesia within 4 weeks
  • Unresolved occlusive or sub-occlusive intestinal disease or any significant chronic intestinal disease (e.g. ulcerative colitis)
  • Prior radiation to >=30% of the bone marrow and/or radiation within 4 weeks prior to enrollment
  • Acute or chronic hepatitis
  • Known HIV infection
  • A marked baseline prolongation of QT/QTc interval (e.g., repeated demonstration of a QTc interval >450 ms
  • A history of additional risk factors for Torsade de Pointes (e.g., heart failure hypokalemia, family history of Long QT Syndrome)
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00359476


Locations
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Korea, Republic of
Local Institution
Suwon-Si, Gyeonggi-Do, Korea, Republic of, 442-723
Local Institution
Gyeonggi-Do, Korea, Republic of, 410-769
Local Institution
Seoul, Korea, Republic of, 120-752
Local Institution
Seoul, Korea, Republic of, 136-705
Malaysia
Local Institution
Nilai, Negeri Sembilan, Malaysia, 71800
Philippines
Local Institution
Quezon City, Philippines, 1102
Sponsors and Collaborators
Bristol-Myers Squibb
Investigators
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Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
More Information
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Responsible Party: Study Director, Bristol-Myers Squibb
ClinicalTrials.gov Identifier: NCT00359476    
Other Study ID Numbers: CA183-023
First Posted: August 2, 2006    Key Record Dates
Last Update Posted: March 2, 2010
Last Verified: December 2007
Keywords provided by Bristol-Myers Squibb:
Locally advanced/metastatic gastric adenocarcinoma
adenocarcinoma-gastroesophageal junction
Gastric Adenocarcinoma
Additional relevant MeSH terms:
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Stomach Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
 Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Stomach Diseases