A Study of Vinflunine in Patients With Gastric Cancer

• Sponsor: Bristol-Myers Squibb (Industry)
• Overall Status: Terminated
• CT.gov ID: NCT00359476
• Collaborator: (none)
• Enrollment: 55
• Locations: 6
• Arm: 1
• Duration (Months): 8
• Patients Per Site: 9.2
• Patients Per Site Per Month: 1.1

Study Details

Study Description

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

• Study Type: Interventional
• Anticipated 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: Mar 1, 2007
• Actual Primary Completion Date: Oct 1, 2007
• Actual Study Completion Date: Nov 1, 2007

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 1	Drug: Vinflunine; solution for injection, IV, 280/320 mg/m2, every 3 wks, variable duration

Outcome Measures

Primary Outcome Measures

1. 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

1. Estimation of the progression free survival and overall survival [At the end of the study]

2. The estimation of the disease control rate [At the end of the study]

3. The time to response and the duration of response [At the end of the study]

4. The evaluation of the safety profile of vinflunine [At the end of the study]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Locations

	Site	City	State	Country	Postal Code
1	Local Institution	Suwon-Si	Gyeonggi-Do	Korea, Republic of	442-723
2	Local Institution	Gyeonggi-Do		Korea, Republic of	410-769
3	Local Institution	Seoul		Korea, Republic of	120-752
4	Local Institution	Seoul		Korea, Republic of	136-705
5	Local Institution	Nilai	Negeri Sembilan	Malaysia	71800
6	Local Institution	Quezon City		Philippines	1102

Sponsors and Collaborators

• Bristol-Myers Squibb

Investigators

• Study Director: Bristol-Myers Squibb, Bristol-Myers Squibb

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT00359476
• Other Study ID Numbers: CA183-023
• First Posted: Aug 2, 2006
• Last Update Posted: Mar 2, 2010
• Last Verified: Dec 1, 2007

• Keywords provided by , ,: Locally advanced/metastatic gastric adenocarcinoma; adenocarcinoma-gastroesophageal junction; Gastric Adenocarcinoma
• Additional relevant MeSH terms: Stomach Neoplasms

Study Results

No Results Posted as of Mar 2, 2010