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Phase II Study of ABI-007 for Gastric Cancer
This study is currently recruiting participants.
Verified by Taiho Pharmaceutical Co., Ltd., July 2008
Sponsored by: Taiho Pharmaceutical Co., Ltd.
Information provided by: Taiho Pharmaceutical Co., Ltd.
ClinicalTrials.gov Identifier: NCT00661167
  Purpose

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.


Condition Intervention Phase
Gastric Cancer
 Drug: ABI-007
 Phase II

MedlinePlus related topics: Cancer Stomach Cancer
Drug Information available for: Paclitaxel Fluorouracil
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
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.

Further study details as provided by Taiho Pharmaceutical Co., Ltd.:

Primary Outcome Measures:
  • Overall response rate [ Time Frame: During chemotherapy ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Safety [ Time Frame: During chemotherapy ] [ Designated as safety issue: Yes ]
  • Progression-free survival [ Time Frame: Until progression ] [ Designated as safety issue: No ]
  • Overall survival [ Time Frame: Over a year form randomaization ] [ Designated as safety issue: No ]
  • Disease control rate [ Time Frame: Duration chemoterapy ] [ Designated as safety issue: No ]

Estimated Enrollment: 53
Study Start Date: April 2008
Estimated Study Completion Date: September 2010
Estimated Primary Completion Date: September 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
1: Experimental
ABI-007
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.

  Eligibility

Ages Eligible for Study:   20 Years to 74 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00661167

Contacts
Contact: Tomohiro Kanno +81- 3- 3293- 2113 tom-kanno@taiho.co.jp

Locations
Japan
National Kyusyu Cancer Center Recruiting
Fukuoka, Japan, 811- 1395
Contact: Yasushi Toh, MD     +81- 92- 541- 3231        
Kochi Health Sciences Center Recruiting
Kochi, Japan, 781- 855
Contact: Akihito Tsuji, MD     +81- 88- 837- 3000        
Japan, Aichi
Aichi Cancer Center Recruiting
Nagoya, Aichi, Japan, 464-8681
Contact: Kei Muro, MD     +81- 52- 762- 6111        
Japan, Ehime
Shikoku Cancer Center Recruiting
Matsuyama, Ehime, Japan, 791- 0280
Contact: Hiroyuki Nishina, MD     +81- 89- 999- 1111        
Japan, Kanagawa
Kitasato University East Hospital Recruiting
Sagamihara, Kanagawa, Japan, 228-8520
Contact: Wasaburo Koizumi, MD     +81- 42- 748- 9111        
Japan, Nagano
Saku Central Hospital Nagano Prefectural Federation of Agricultural Cooperatives for Health and Welfare Recruiting
Saku, Nagano, Japan, 384-0301
Contact: Yoshinori Miyata, MD     +81- 267- 82- 3131        
Japan, Osaka
Osaka Medical College Hospital Recruiting
Takatsuki, Osaka, Japan, 569- 8686
Contact: Hiroya Takiuchi, MD     +81- 72- 683- 1221        
Japan, Saitama
Saitama International medical center-comprehensive cancer center, Saitama Medical University Recruiting
Hidaka, Saitama, Japan, 350-1298
Contact: Yasutsuna Sasaki, MD     +81- 42- 984- 4111        
Japan, Shizuoka
Shizuoka Cancer Center Recruiting
Sunto, Shizuoka, Japan, 411- 8777
Contact: Hirofumi Yasui, MD     +81- 55- 989- 5222        
Japan, Toyama
Kouseiren Takaoka Hospital Recruiting
Takaoka, Toyama, Japan, 933- 8555
Contact: Takuo Hara, MD     +81- 766- 21- 3930        
Sponsors and Collaborators
Taiho Pharmaceutical Co., Ltd.
Investigators
Study Chair: Nagahiro Saijo, MD National Cancer Center Hospital East
  More Information

Responsible Party: Taiho Pharmaceutical Co., Ltd. ( Taiho Pharmaceutical Co., Ltd. )
Study ID Numbers: Taiho10041040
Study First Received: April 16, 2008
Last Updated: July 31, 2008
ClinicalTrials.gov Identifier: NCT00661167  
Health Authority: Japan: Ministry of Health, Labor and Welfare

Study placed in the following topic categories:
Stomach Diseases
Digestive System Diseases
Digestive System Neoplasms
Paclitaxel
Gastrointestinal Diseases
 Fluorouracil
Stomach Neoplasms
Gastrointestinal Neoplasms
Stomach cancer
Recurrence

Additional relevant MeSH terms:
Neoplasms
Neoplasms by Site
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Therapeutic Uses
 Mitosis Modulators
Tubulin Modulators
Antimitotic Agents
Antineoplastic Agents, Phytogenic
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 15, 2009



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