Full Text View  
  Tabular View  
  Contacts and Locations  
  No Study Results Posted  
  Related Studies  
AZD0530 as First-Line Therapy in Treating Patients With Locally Advanced or Metastatic Stomach or Gastroesophageal Junction Cancer
This study is currently recruiting participants.
Verified by National Cancer Institute (NCI), April 2008
Sponsors and Collaborators: Princess Margaret Hospital, Canada
National Cancer Institute (NCI)
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00607594
  Purpose

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
U.S. FDA Resources
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

Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:
  • Objective tumor response (defined as partial or complete response by RECIST criteria) [ Designated as safety issue: No ]
  • Prolonged stable disease rate (defined as stable disease for ≥ 16 weeks) [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Time to progression (median, 6 months, and 1 year) [ Designated as safety issue: No ]
  • Progression free survival [ Designated as safety issue: No ]
  • Median survival [ Designated as safety issue: No ]
  • Overall survival (median, 6 months, and 1 year) [ Designated as safety issue: No ]
  • Safety [ Designated as safety issue: Yes ]
  • Tolerability [ Designated as safety issue: No ]
  • Association between correlative markers and clinical outcomes [ Designated as safety issue: No ]

Estimated Enrollment: 35
Study Start Date: January 2008
Estimated Primary Completion Date: June 2008 (Final data collection date for primary outcome measure)
Detailed Description:

OBJECTIVES:

Primary

  • To assess the objective disease control rate (i.e., partial or complete response as defined by RECIST criteria or stable disease for ≥ 16 weeks) in patients with locally advanced or metastatic adenocarcinoma of the stomach or gastroesophageal junction treated with AZD0530.

Secondary

  • To assess the median time to disease progression, median overall survival, and 1-year survival rate in these patients.
  • To assess the toxicity of AZD0530 in these patients.
  • To evaluate potential predictive markers by assessing pretreatment intratumoral levels of src, Y419 phospho-src (P-Src), and c-terminal src kinase (Csk) in archival tumor biopsies.

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

DISEASE CHARACTERISTICS:

  • Histologically or cytologically confirmed adenocarcinoma of the stomach or gastroesophageal junction (GEJ)

    • Tumors of the GEJ must be sub-specified as type I, II, or III using the Siewert classification
  • Metastatic or locally advanced disease

    • Patients with local/regional disease only, must have unresectable disease
  • Measurable disease, defined as ≥ 1 lesion that can be accurately measured in ≥ 1 dimension (longest diameter to be recorded) as ≥ 20 mm by conventional techniques or as ≥ 10 mm by spiral CT scan
  • No known brain metastases

PATIENT CHARACTERISTICS:

  • ECOG performance status (PS) 0-2 OR Karnofsky PS 60-100%
  • Life expectancy > 3 months
  • Platelet count ≥ 100,000/mm³
  • Leukocytes ≥ 3,000/mm³
  • Absolute neutrophil count ≥ 1,500/mm³
  • Hemoglobin > 9 g/dL
  • Total bilirubin normal
  • AST/ALT ≤ 2.5 times upper limit of normal
  • Creatinine normal OR creatinine clearance ≥ 60 mL/min
  • Urine protein creatinine ratio < 1.0 OR urine protein < 1,000 mg by 24-hour urine collection
  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception
  • No condition that potentially impairs the ability to swallow or absorb AZD0530, including any of the following:

    • Gastrointestinal tract disease resulting in an inability to take oral medication or a requirement for IV alimentation
    • Active peptic ulcer disease
    • Short gut syndrome
    • Malabsorption syndrome of any type
    • Total or partial bowel obstruction
    • Inability to tolerate oral medications
  • No history of allergic reactions attributed to compounds of similar chemical or biologic composition to AZD0530
  • No QTc prolongation (defined as a QTc interval ≥ 460 msec) or other significant ECG abnormalities
  • No poorly controlled hypertension (i.e., systolic blood pressure [BP] ≥ 140 mm Hg or diastolic BP ≥ 90 mm Hg)
  • No history of ischemic heart disease, including myocardial infarction
  • No concurrent cardiac dysfunction including, but not limited to, any of the following:

    • Symptomatic congestive heart failure
    • Unstable angina pectoris
    • Cardiac arrhythmia
  • No other concurrent uncontrolled illness, including ongoing or active infection or psychiatric illness/social situations, that would limit compliance with study requirements

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)

    • At least 4 weeks since prior chemotherapy
  • At least 4 weeks since prior radiotherapy and recovered
  • At least 4 weeks since prior major surgery and recovered
  • No CYP3A4 active agents or substances for ≥ 7 days before, during, and for ≥ 7 days after completion of study treatment
  • No other concurrent investigational agents
  • No other concurrent anticancer therapy
  • No concurrent combination antiretroviral therapy for HIV-positive patients
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00607594

Locations
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    
Sponsors and Collaborators
Princess Margaret Hospital, Canada
Investigators
Study Chair: Heather-Jane Au, MD Cross Cancer Institute at University of Alberta
  More Information

Clinical trial summary from the National Cancer Institute's PDQ® database  This link exits the ClinicalTrials.gov site

Study ID Numbers: CDR0000585708, PMH-PHL-052
Study First Received: February 1, 2008
Last Updated: October 8, 2008
ClinicalTrials.gov Identifier: NCT00607594  
Health Authority: Unspecified

Keywords provided by National Cancer Institute (NCI):
adenocarcinoma of the stomach
stage III gastric cancer
stage IV gastric cancer

Study placed in the following topic categories:
Stomach Diseases
Digestive System Diseases
Digestive System Neoplasms
Gastrointestinal Diseases
Stomach Neoplasms
Gastrointestinal Neoplasms
Stomach cancer
Adenocarcinoma
Carcinoma

Additional relevant MeSH terms:
Neoplasms
Neoplasms by Site

ClinicalTrials.gov processed this record on January 16, 2009