Clinical Trial · NCT01939275

64Cu DOTA-Trastuzumab PET/CT in Studying Patients With Gastric Cancer

Overview

This pilot clinical trial studies copper Cu 64 (64Cu) tetra-azacyclododecanetetra-acetic acid (DOTA)-trastuzumab positron emission tomography (PET)/computed tomography (CT) in studying patients with gastric, or stomach cancer. Diagnostic procedures, such as copper Cu 64-DOTA-trastuzumab PET/CT, may help doctors study the characteristics of tumors and choose the best treatment.

Sponsor

City of Hope Medical Center

Phase

N/A

Contacts

Yanghee Woo, MD (PRINCIPAL_INVESTIGATOR)

ClinicalTrials.gov

NCT01939275

Drug / Compound

trastuzumab

Isotope(s):

Target(s):

HER2

Ligand Class: Antibodies

Chelator: DOTA

Eligibility

Inclusion

Either the primary tumor or at least one of the metastatic lesions must be \>= 2 cm
Two patients must be HER2 3+ by immunohistochemistry (IHC) or fluorescence in situ hybridization (FISH) positive
CT/magnetic resonance imaging (MRI) scan must be obtained within 4 weeks prior to study entry
Patient must have a histologic diagnosis of gastric or gastroesophageal junction adenocarcinoma
All toxicities should recover to grade 0 or 1 prior to day 1
Women of childbearing potential must have a negative serum pregnancy test within 14 days of copper Cu 64-DOTA administrations and must have agreed to use an effective contraceptive method; women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control or abstinence) prior to study entry and for four months following duration of study participation; should a woman become pregnant or suspect that she is pregnant while participating on the trial, she should inform her treating physician immediately
Life expectancy of \>= 3 months
Eastern Cooperative Oncology Group (ECOG) performance status of 0-2
Patients must have normal cardiac ejection fraction

Exclusion

Subjects, who in the opinion of the investigator, may not be able to comply with the safety monitoring requirements of the study
Congestive heart failure (New York Heart Association functional classification III-IV)
Patients may not be receiving any other investigational agents
Patients who are pregnant
Patients who may not have received trastuzumab within the prior 6 months for any other reason
Presence of atrial fibrillation
At the time of enrollment, patients may not have received any biological, chemotherapy, or radiation therapy
Impaired cardiac function including any one of the following: complete left bundle branch block or use of a permanent cardiac pacemaker, congenital long QT syndrome, presence of ventricular tachyarrhythmias, clinically significant resting bradycardia (\< 50 beats per minute), QT interval corrected by Fridericia's formula (QTcF) \> 450 msec on screening electrocardiogram (ECG), or right bundle branch block + left anterior hemiblock (bifascicular block)
Uncontrolled hypertension (mmHg \> 160 systolic or \> 90 diastolic)
Previous history of angina pectoris or acute myocardial infarction (MI) within 6 months