Clinical trial NCT00359476: A Study of Vinflunine in Patients With Gastric Cancer
Official title: A Multicenter, Single-Arm, Phase II Study of Single-Agent Vinflunine in the Second-line Treatment of Patients With Gastric Cancer
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
PHASE3
Conditions: Stomach Cancer
Keywords: Locally advanced/metastatic gastric adenocarcinoma
adenocarcinoma-gastroesophageal junction
Gastric Adenocarcinoma
Lead sponsor: Bristol-Myers Squibb
Sponsor class: INDUSTRY
First posted: 2006-08-02
Enrollment: 55
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility 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)

Primary outcomes:
measure: The Response Rate (RR: Complete Response [CR]+Partial Response [PR], as defined by Response Evaluation Criteria in Solid Tumors [RECIST]
timeFrame: throughout the study
Secondary outcomes:
measure: Estimation of the progression free survival and overall survival
timeFrame: At the end of the study
measure: The estimation of the disease control rate
timeFrame: At the end of the study
measure: The time to response and the duration of response
timeFrame: At the end of the study
measure: The evaluation of the safety profile of vinflunine
timeFrame: At the end of the study
Other outcomes:
Locations:
city: Suwon-Si
country: Korea, Republic of
facility: Local Institution
state: Gyeonggi-Do
city: Gyeonggi-Do
country: Korea, Republic of
facility: Local Institution
city: Seoul
country: Korea, Republic of
facility: Local Institution
city: Seoul
country: Korea, Republic of
facility: Local Institution
city: Nilai
country: Malaysia
facility: Local Institution
state: Negeri Sembilan
city: Quezon City
country: Philippines
facility: Local Institution
Study officials:
affiliation: Bristol-Myers Squibb
name: Bristol-Myers Squibb
role: STUDY_DIRECTOR
References: