Status:
COMPLETED
Saracatinib in Treating Patients With Locally Advanced or Metastatic Stomach or Gastroesophageal Junction Cancer
Lead Sponsor:
National Cancer Institute (NCI)
Conditions:
Adenocarcinoma of the Gastroesophageal Junction
Adenocarcinoma of the Stomach
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
This phase II trial is studying how well saracatinib works in treating patients with locally advanced or metastatic stomach or gastroesophageal junction cancer. Saracatinib may stop the growth of tumo...
Detailed Description
PRIMARY OBJECTIVES: I. To assess the objective disease control rate (i.e., partial or complete response as defined by Response Evaluation Criteria in Solid Tumors (RECIST) criteria or stable disease ...
Eligibility Criteria
Inclusion
- 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 computed tomography (CT) scan
- No known brain metastases
- Eastern Cooperative Oncology Group (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
- Aspartate aminotransferase (AST)/alanine aminotransferase (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
Exclusion
- 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 electrocardiogram (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 chemotherapy allowed provided it was administered as part of initial curative intent therapy (i.e., neoadjuvant therapy, adjuvant therapy and/or concurrently with radiotherapy) in combination with surgery
- At least 4 weeks since prior chemotherapy
- At least 4 weeks since prior and no more than 1 line of palliative chemotherapy for advanced disease
- At least 4 weeks since prior radiotherapy and recovered
- At least 4 weeks since prior major surgery and recovered
- No cytochrome 450 3A4 (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 human immunodeficiency virus (HIV)-positive patients
Key Trial Info
Start Date :
January 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2012
Estimated Enrollment :
21 Patients enrolled
Trial Details
Trial ID
NCT00607594
Start Date
January 1 2008
End Date
April 1 2012
Last Update
August 23 2018
Active Locations (5)
Enter a location and click search to find clinical trials sorted by distance.
1
Hamilton Medical Center
Dalton, Georgia, United States, 30720
2
Cross Cancer Institute
Edmonton, Alberta, Canada, T6G 1Z2
3
Juravinski Cancer Centre at Hamilton Health Sciences
Hamilton, Ontario, Canada, L8V 5C2
4
University Health Network-Princess Margaret Hospital
Toronto, Ontario, Canada, M5G 2M9