A Study of Vinflunine in Patients With Gastric Cancer

NCT00359476 | Terminated Phase 2

• 1 other identifier: CA183-023
• Study Type: interventional
• Target: 55
• Locations: 3 countries
• Sites: 6

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.

Conditions

Stomach Cancer

Keywords

Locally advanced/metastatic gastric adenocarcinoma; adenocarcinoma-gastroesophageal junction; Gastric Adenocarcinoma

Outcome Measures

Primary Outcomes (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 Outcomes (4)

• 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

Study Arms (1)

1

EXPERIMENTAL

Drug: Vinflunine

Interventions

Vinflunine DRUG

solution for injection, IV, 280/320 mg/m2, every 3 wks, variable duration

1

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Bristol-Myers Squibb: lead

Study Sites (6)

Local Institution

Kampung Baharu Nilai, Negeri Sembilan, 71800, Malaysia

Location

Local Institution

Quezon City, 1102, Philippines

Location

Local Institution

Suwon, Gyeonggi-do, 442-723, South Korea

Location

Local Institution

Gyeonggi-do, 410-769, South Korea

Location

Local Institution

Seoul, 120-752, South Korea

Location

Local Institution

Seoul, 136-705, South Korea

Location

MeSH Terms

Conditions

Stomach Neoplasms

Interventions

vinflunine

Condition Hierarchy (Ancestors)

Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Stomach Diseases

Study Officials

• Bristol-Myers Squibb

  Bristol-Myers Squibb

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: August 1, 2006
• First Posted: August 2, 2006
• Study Start: March 1, 2007
• Primary Completion: October 1, 2007
• Study Completion: November 1, 2007
• Last Updated: March 2, 2010

Record last verified: 2007-12

Locations

MY (1); KR (4); PH (1)