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Sponsors and Collaborators: |
Princess Margaret Hospital, Canada National Cancer Institute (NCI) |
Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00607594 |
RATIONALE: AZD0530 may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.
PURPOSE: This phase II trial is studying how well AZD0530 works as first-line therapy in treating patients with locally advanced or metastatic stomach or gastroesophageal junction cancer.
Condition | Intervention | Phase |
Gastric Cancer |
Drug: AZD0530 Procedure: high performance liquid chromatography Procedure: immunoenzyme technique Procedure: immunohistochemistry staining method Procedure: laboratory biomarker analysis Procedure: mass spectrometry Procedure: pharmacological study Procedure: protein expression analysis |
Phase II |
MedlinePlus related topics: | Cancer Stomach Cancer |
Study Type: | Interventional |
Study Design: | Treatment, Open Label |
Official Title: | A Phase 2 Study of AZD0530 as First Line Treatment in Patients With Metastatic or Locally Advanced Gastric Carcinoma |
Estimated Enrollment: | 35 |
Study Start Date: | January 2008 |
Estimated Primary Completion Date: | June 2008 (Final data collection date for primary outcome measure) |
OBJECTIVES:
Primary
Secondary
OUTLINE: This is a multicenter study.
Patients receive oral AZD0530 daily in the absence of disease progression or unacceptable toxicity.
Patients undergo tumor tissue and blood sample collection periodically for correlative laboratory studies. Tumor tissue samples are analyzed for c-Src protein expression and activity and phosphorylation of focal adhesion kinase (FAK), paxillin, caveolin, and Stat-3 by immunofluorescence methods and P-glycoprotein levels by immunohistochemistry. Blood samples are analyzed for vascular endothelial growth factor (VEGF) levels by ELISA; AZD0530 concentration by high-performance liquid chromatography with tandem mass spectrometry; and pharmacokinetics.
After completion of study treatment, patients are followed periodically.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically or cytologically confirmed adenocarcinoma of the stomach or gastroesophageal junction (GEJ)
Metastatic or locally advanced disease
PATIENT CHARACTERISTICS:
No condition that potentially impairs the ability to swallow or absorb AZD0530, including any of the following:
No concurrent cardiac dysfunction including, but not limited to, any of the following:
PRIOR CONCURRENT THERAPY:
Prior chemotherapy allowed provided it was administered as part of initial curative intent therapy (i.e., neoadjuvant therapy, concurrent therapy, and/or adjuvant therapy) in combination with surgery (with or without radiotherapy)
Canada, Alberta | |||||
Cross Cancer Institute at University of Alberta | Recruiting | ||||
Edmonton, Alberta, Canada, T6G 1Z2 | |||||
Contact: Heather-Jane Au, MD 780-432-8762 | |||||
Canada, British Columbia | |||||
British Columbia Cancer Agency - Vancouver Cancer Centre | Recruiting | ||||
Vancouver, British Columbia, Canada, V5Z 4E6 | |||||
Contact: Christian Kollmannsberger, MD 604-877-6000 ext. 2674 | |||||
Canada, Ontario | |||||
Ottawa Hospital Regional Cancer Centre - General Campus | Recruiting | ||||
Ottawa, Ontario, Canada, K1H 8L6 | |||||
Contact: Laura Chow, MD 613-737-7700 ext. 70337 | |||||
Princess Margaret Hospital | Recruiting | ||||
Toronto, Ontario, Canada, M5G 2M9 | |||||
Contact: Amit M. Oza, MD 416-946-2818 | |||||
Canada, Quebec | |||||
Montreal General Hospital | Recruiting | ||||
Montreal, Quebec, Canada, H3H 1A4 | |||||
Contact: Thierry Alcindor, MD 514-934-1934 ext. 43118 thierry.alcindor@muhc.mcgill.ca |
Princess Margaret Hospital, Canada |
National Cancer Institute (NCI) |
Study Chair: | Heather-Jane Au, MD | Cross Cancer Institute at University of Alberta |
Clinical trial summary from the National Cancer Institute's PDQ® database 
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Study ID Numbers: | CDR0000585708, PMH-PHL-052 |
First Received: | February 1, 2008 |
Last Updated: | October 8, 2008 |
ClinicalTrials.gov Identifier: | NCT00607594 |
Health Authority: | Unspecified |
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