A Study of Vinflunine in Patients With Gastric Cancer

Study Overview
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Brief Summary
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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.

Official Title
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A Multicenter, Single-Arm, Phase II Study of Single-Agent Vinflunine in the Second-line Treatment of Patients With Gastric Cancer

Conditions
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Stomach Cancer

Intervention / Treatment
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* Drug: Vinflunine


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br> | Drug: Vinflunine<br>* solution for injection, IV, 280/320 mg/m2, every 3 wks, variable duration<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The Response Rate (RR: Complete Response [CR]+Partial Response [PR], as defined by Response Evaluation Criteria in Solid Tumors [RECIST] |  | throughout the study | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Estimation of the progression free survival and overall survival |  | At the end of the study | 
| The estimation of the disease control rate |  | At the end of the study | 
| The time to response and the duration of response |  | At the end of the study | 
| The evaluation of the safety profile of vinflunine |  | At the end of the study | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Locally advanced/metastatic gastric adenocarcinoma, adenocarcinoma-gastroesophageal junction, Gastric Adenocarcinoma