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

NCT ID: NCT00607594

Last Updated: 2018-08-23

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 21 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-01-31
• Study Completion Date: 2012-04-30

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

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 for ≥ 16 weeks) in patients with locally advanced or metastatic adenocarcinoma of the stomach or gastroesophageal junction treated with AZD0530 (saracatinib).

SECONDARY OBJECTIVES:

I. To assess the median time to disease progression, median overall survival, and 1-year survival rate in these patients.

II. To assess the toxicity of AZD0530 in these patients. III. 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:

Patients receive saracatinib orally (PO) once daily (QD) in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed up at least every 2 months.

Conditions

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Treatment (kinase inhibitor therapy)

Patients receive saracatinib PO, at a dose of 175 mg QD in the absence of disease progression or unacceptable toxicity.

Group Type: EXPERIMENTAL

saracatinib

Intervention Type: DRUG

Patients receive AZD0530 (saracatinib) PO QD in the absence of disease progression or unacceptable toxicity.

Interventions

saracatinib

Patients receive AZD0530 (saracatinib) PO QD in the absence of disease progression or unacceptable toxicity.

Intervention Type: DRUG

Other Intervention Names

AZD0530

Eligibility Criteria

Inclusion Criteria

• 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 Criteria

• 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Cancer Institute (NCI)

NIH

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Heather-Jane Au

Role: PRINCIPAL_INVESTIGATOR

University Health Network-Princess Margaret Hospital

Locations

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

Countries

United States; Canada

Other Identifiers

PHL-052

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

CDR0000585708

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

PMH-PHL-052

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

N01CM62203

Identifier Type: NIH

Identifier Source: secondary_id

View Link

NCI-2009-00188

Identifier Type: -

Identifier Source: org_study_id