Saracatinib in Treating Patients With Locally Advanced or Metastatic Stomach or Gastroesophageal Junction Cancer

Completed · Phase 2

Conditions studied: Adenocarcinoma of the Gastroesophageal Junction, Adenocarcinoma of the Stomach, Recurrent Gastric Cancer, Stage III Gastric Cancer, Stage III Esophageal Cancer, Stage IV Esophageal Cancer, Stage IV Gastric Cancer

In brief

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 tumor cells by blocking some of the enzymes needed for cell growth.

Key facts

Study ID

NCT00607594

Run by

National Cancer Institute (NCI)

People needed

21

Starts

2008-01-01

Expected to finish

2012-04-01

Last updated by the study team

2018-08-23

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Hamilton Medical Center — Dalton, Georgia, United States
• Cross Cancer Institute — Edmonton, Alberta, Canada
• Juravinski Cancer Centre at Hamilton Health Sciences — Hamilton, Ontario, Canada
• University Health Network-Princess Margaret Hospital — Toronto, Ontario, Canada
• McGill University Department of Oncology — Montreal, Quebec, Canada

Full record on ClinicalTrials.gov

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