Phase II Study of ABI-007 for Gastric Cancer

Gastric Cancer Clinical Trial

Official title:

Phase II Study of ABI-007 by Tri-weekly Schedule for Patients With Unresectable or Recurrent Gastric Cancer Refractory to 5-FU Containing Regimen.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00661167
• Other study ID #: Taiho10041040
• Status: Completed
• Phase: Phase 2
• First received: April 16, 2008
• Last updated: January 16, 2012
• Start date: April 2008
• Est. completion date: December 2011

Study information

• Verified date: January 2012
• Source: Taiho Pharmaceutical Co., Ltd.
• Contact: n/a
• Is FDA regulated: No
• Health authority: Japan: Ministry of Health, Labor and Welfare
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to evaluate the efficacy and safety of tri-weekly ABI-007 for recurrence or unresectable gastric cancer patients who have received one prior regimen containing fluoropyrimidine and developed disease progression or recurrence.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 56
• Est. completion date: December 2011
• Est. primary completion date: May 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years to 74 Years

Eligibility

Inclusion Criteria:

• Histologically or cytologically confirmed gastric adenocarcinoma

• Received one prior regimen containing fluoropyrimidine analogs and developed disease progression or recurrence

• Age: 20 - 74

• At least one measurable lesion by RECIST criteria

Exclusion Criteria:

• History of Taxans use

• Patients with another active malignancy

• Pre-existing peripheral neuropathy of Grade 2, 3, or 4 (per CTCAE)

• Chronic treatment with steroids

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Gastric Cancer
• Stomach Neoplasms

Intervention

Drug:
• ABI-007
ABI-007 260 mg/m2, IV on day 1 of each 21 day cycle. Number of cycles: until progression or unacceptable toxicity develops.

Locations

Country	Name	City	State
Japan	National Kyusyu Cancer Center	Fukuoka
Japan	Saitama International medical center-comprehensive cancer center, Saitama Medical University	Hidaka	Saitama
Japan	Kochi Health Sciences Center	Kochi
Japan	Shikoku Cancer Center	Matsuyama	Ehime
Japan	Aichi Cancer Center	Nagoya	Aichi
Japan	Kitasato University East Hospital	Sagamihara	Kanagawa
Japan	Saku Central Hospital Nagano Prefectural Federation of Agricultural Cooperatives for Health and Welfare	Saku	Nagano
Japan	Shizuoka Cancer Center	Sunto	Shizuoka
Japan	Kouseiren Takaoka Hospital	Takaoka	Toyama
Japan	Osaka Medical College Hospital	Takatsuki	Osaka

Sponsors (1)

Lead Sponsor	Collaborator
Taiho Pharmaceutical Co., Ltd.

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Overall response rate		During chemotherapy	No
Secondary	Safety		During chemotherapy	Yes
Secondary	Progression-free survival		Until progression	No
Secondary	Overall survival		Over a year form randomaization	No
Secondary	Disease control rate		Duration chemoterapy	No