Clinical trial NCT01939275: 64Cu DOTA-Trastuzumab PET/CT in Studying Patients With Gastric Cancer
Official title: 64Cu-DOTA-trastuzumab Positron Emission Tomography in Patients With Gastric Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
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
Stage IV Gastric Cancer
Lead sponsor: City of Hope Medical Center
Sponsor class: OTHER
First posted: 2013-09-11
Enrollment: 8
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: 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.

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-CT scan with standard radiographic imaging for staging patients with gastric cancer.

OUTLINE:

Patients receive copper Cu 64-DOTA-trastuzumab intravenously (IV) on day 1 and then undergo PET/CT scan on days 2 or 3.

After completion of study, patients are followed up for 15 days and periodically for up to 6 months.

Eligibility criteria: Inclusion Criteria:

* Patient must have a histologic diagnosis of gastric or gastroesophageal junction adenocarcinoma
* Two patients must be HER2 3+ by immunohistochemistry (IHC) or fluorescence in situ hybridization (FISH) positive
* Either the primary tumor or at least one of the metastatic lesions must be \>= 2 cm
* Eastern Cooperative Oncology Group (ECOG) performance status of 0-2
* Life expectancy of \>= 3 months
* 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
* CT/magnetic resonance imaging (MRI) scan must be obtained within 4 weeks prior to study entry
* Patients must have normal cardiac ejection fraction
* 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:

* 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)
* Patients should not have active infections or concurrent neoplastic disease except for skin cancer
* Patients may not be receiving any other investigational agents
* At the time of enrollment, patients may not have received any biological, chemotherapy, or radiation therapy
* Patients who may not have received trastuzumab within the prior 6 months for any other reason
* Patients who are pregnant
* Subjects, who in the opinion of the investigator, may not be able to comply with the safety monitoring requirements of the study

Primary outcomes:
measure: Number of HER2 Negative, Positive, or Equivocal Participants With Either Negative or Positive Tumor Readings
timeFrame: Up to 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Duarte
country: United States
facility: City of Hope Medical Center
state: California
Study officials:
affiliation: City of Hope Medical Center
name: Yanghee Woo, MD
role: PRINCIPAL_INVESTIGATOR
References: