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

This study is currently recruiting participants. (see Contacts and Locations)
Verified September 2016 by City of Hope Medical Center
Sponsor:
Information provided by (Responsible Party):
City of Hope Medical Center
ClinicalTrials.gov Identifier:
NCT01939275
First received: September 6, 2013
Last updated: September 16, 2016
Last verified: September 2016
  Purpose
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.

Condition Intervention
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
Radiation: copper Cu 64-DOTA-trastuzumab
Device: positron emission tomography
Other: laboratory biomarker analysis
Procedure: Computed Tomography

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: 64Cu-DOTA-trastuzumab Positron Emission Tomography in Patients With Gastric Cancer

Resource links provided by NLM:


Further study details as provided by City of Hope Medical Center:

Primary Outcome Measures:
  • Tumor uptake of copper Cu 64-DOTA trastuzumab [ Time Frame: Up to 1 year ] [ Designated as safety issue: No ]
    Parameterized in terms of single-voxel maximum values peak standardized uptake value (SUVmax) and whole-tumor volumes of interest (SUVwhtum). Ratios of tumor to non-tumor activity concentration will be calculated. Receiver-operator curve (ROC) analysis will be performed to estimate optimal cutoff values of SUVmax, SUVwhtum, tumor:background, and tumor:organ ratios for classifying tumors as "HER2 positive" or "HER2 negative".

  • Percent of patients whose tumors image with Cu-PET/CT [ Time Frame: Up to 1 year ] [ Designated as safety issue: No ]
    Estimated with a 95% confidence interval (CI) half-width of 21%.

  • Percent of patients deemed negative by pathology, but appear positive by CU-PET/CT [ Time Frame: Up to 1 year ] [ Designated as safety issue: No ]
  • Pathologic confirmation of Cu-PET/CT SUV variation over the tumor [ Time Frame: Up to 1 year ] [ Designated as safety issue: No ]
    Positive and negative areas of the tumor will be sent to pathology for confirmation. This will be exploratory.

  • Pathologic confirmation of Cu-PET/CT SUV [ Time Frame: Up to 1 year ] [ Designated as safety issue: No ]
    Correlation of Cu-PET SUV (measured as peak SUV) and pathology will be explored. As correlation requires a continuous measure from pathology, and some pathology will use FISH and/or IHC, this will be exploratory. Comparing Cu-PET in positive cases versus negative by pathology will depend on the percent of patients deemed positive.


Estimated Enrollment: 22
Study Start Date: September 2014
Estimated Primary Completion Date: July 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Diagnostic (copper Cu 64-DOTA-trastuzumab PET scan)
Patients receive copper Cu 64-DOTA-trastuzumab IV on day 1 and then undergo PET/CT scan on days 2 or 3.
Radiation: copper Cu 64-DOTA-trastuzumab
Undergo Copper Cu 64-DOTA-trastuzumab PET/CT scan
Other Name: 64Cu-DOTA-trastuzumab
Device: positron emission tomography
Undergo Copper Cu 64-DOTA-trastuzumab PET/CT scan
Other Names:
  • FDG-PET
  • PET
  • PET scan
  • tomography, emission computed
Other: laboratory biomarker analysis
Correlative studies
Procedure: Computed Tomography
Undergo Copper Cu 64-DOTA-trastuzumab PET/CT scan
Other Names:
  • CAT
  • CAT Scan
  • Computerized Axial Tomography
  • Computerized Tomography
  • CT
  • CT Scan
  • tomography

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

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01939275

Locations
United States, California
City of Hope Medical Center Recruiting
Duarte, California, United States, 91010
Contact: Yanghee Woo, MD    626-256-4573      
Principal Investigator: Yanghee Woo, MD         
Sponsors and Collaborators
City of Hope Medical Center
Investigators
Principal Investigator: Yanghee Woo, MD City of Hope Medical Center
  More Information

Responsible Party: City of Hope Medical Center
ClinicalTrials.gov Identifier: NCT01939275     History of Changes
Other Study ID Numbers: 13229  NCI-2013-01721  13229 
Study First Received: September 6, 2013
Last Updated: September 16, 2016
Health Authority: United States: Federal Government
United States: Food and Drug Administration

Additional relevant MeSH terms:
Stomach Neoplasms
Adenocarcinoma
Esophageal Neoplasms
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Gastrointestinal Diseases
Stomach Diseases
Head and Neck Neoplasms
Esophageal Diseases
Trastuzumab
Copper
Antineoplastic Agents
Trace Elements
Micronutrients
Growth Substances
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on September 23, 2016