64Cu DOTA-Trastuzumab PET in Studying Patients With Gastric Cancer
Conditions
Adenocarcinoma of the Gastroesophageal Junction - Diffuse Adenocarcinoma of the Stomach - Intestinal Adenocarcinoma of the Stomach - Mixed Adenocarcinoma of the Stomach - Recurrent Gastric Cancer - Stage IA Gastric Cancer - Stage IB Gastric Cancer - Stage IIA Gastric Cancer - Stage IIB Gastric Cancer - Stage IIIA Gastric Cancer - Stage IIIB Gastric Cancer - Stage IIIC Gastric Cancer
Conditions: official terms
Adenocarcinoma - Esophageal Neoplasms - Stomach Neoplasms
Study Type
Interventional
Study Phase
N/A
Study Design
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic
Intervention
Name: copper Cu 64-DOTA-trastuzumab Type: Radiation
Name: positron emission tomography Type: Device
Name: laboratory biomarker analysis Type: Other
Overall Status
Recruiting
Summary
This pilot clinical trial studies copper Cu 64 (64Cu) tetra-azacyclododecanetetra-acetic acid (DOTA)-trastuzumab positron emission tomography (PET) in studying patients with gastric, or stomach, cancer. Diagnostic procedures, such as copper Cu 64-DOTA-trastuzumab PET, may help doctors study the characteristics of tumors and choose the best treatment.
Detailed Description
PRIMARY OBJECTIVES:

I. To compare tumor uptake of 64Cu-DOTA-trastuzumab (copper Cu 64-DOTA-trastuzumab) in gastric cancer patients with pathologic evaluation of tumor human epidermal growth factor receptor 2 (HER2)/neu expression.

II. To compare copper Cu 64-DOTA-trastuzumab-PET scan with standard radiographic imaging for staging patients with gastric cancer.

OUTLINE:

Patients undergo copper Cu 64-DOTA-trastuzumab PET scan.

After completion of study, patients are followed up for 15 days and periodically for up to 6 months.
Criteria for eligibility
Healthy Volunteers: No
Maximum Age: N/A
Minimum Age: 18 Years
Gender: Both
Criteria: Inclusion Criteria:

- Patient must have a histologic diagnosis of gastric or gastroesophageal junction adenocarcinoma

- Patient must be a candidate for surgical resection as determined by surgical oncology

- Eastern Cooperative Oncology Group (ECOG) performance status of 0-1

- Women of childbearing potential must have a negative serum pregnancy test within 14 days of copper Cu 64-DOTA administration 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

- Computed tomography (CT)/magnetic resonance imaging (MRI) scan must be obtained within 3 weeks prior to study entry

- Absolute neutrophil count >= 1,500/mcl

- Platelet count >= 100,000/mcl

- Creatinine =< 1.3 mg/dL or a measured creatinine clearance >= 60 cc/min

- Bilirubin =< 1.5 mg/dL

- Alanine aminotransferase (ALT), aspartate aminotransferase (AST) no greater than 1.5 times the upper limit of normal

- Patients currently being treated for severe infections or who are recovering from major surgery or other intercurrent illnesses are ineligible until recovery is deemed complete by the investigator

- Patients must have normal cardiac ejection fraction

- For patients that have received prior therapy, all subjects must have the ability to understand and the willingness to sign a written informed consent

- All toxicities should recover to grade 0 or 1 prior to day 1

Exclusion Criteria:

- Patients with any grade electrolyte abnormalities that are unable to be corrected by day 1

- 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)

- Presence of atrial fibrillation

- Previous history of angina pectoris or acute myocardial infarction (MI) within 6 months

- Congestive heart failure (New York Heart Association functional classification III-IV)

- Uncontrolled hypertension (mmHg > 160 systolic or > 90 diastolic)

- Brain or leptomeningeal metastases

- Patients with an active, bleeding diathesis or requiring therapeutic anticoagulation

- Patients with known positivity for human immunodeficiency virus (HIV) or hepatitis C; baseline testing for HIV and hepatitis C is not required

- Patients should not have any uncontrolled illness including ongoing or active infection

- Patients may not be receiving any other investigational agents, or concurrent biological, chemotherapy, or radiation therapy

- Subjects, who in the opinion of the investigator, may not be able to comply with the safety monitoring requirements of the study
Location
City of Hope Medical Center
Duarte, California, United States
Status: Recruiting
Contact: Vincent Chung - 626-471-9200 - vchung@coh.org
Start Date
September 2014
Sponsors
City of Hope Medical Center
Source
City of Hope Medical Center
Record processing date
ClinicalTrials.gov processed this data on July 28, 2015
ClinicalTrials.gov page