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Labeled PET in Studying Patients With Gastric Cancer

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified March 2014 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: March 20, 2014
Last verified: March 2014
  Purpose

This pilot clinical trial studies copper Cu 64 tetraazacyclododecane-tetraacetic acid (DOTA)-trastuzumab positron emission tomography (PET) in studying patients with gastric cancer. Diagnostic procedures, such as copper Cu 64-DOTA-trastuzumab PET, may help doctors plan 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
Radiation: copper Cu 64-DOTA-trastuzumab
Device: positron emission tomography
Other: laboratory biomarker analysis

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 [ Time Frame: Up to 1 year ] [ Designated as safety issue: No ]
    Estimated with a 95% confidence interval (CI) half-width of 21%.

  • Percent of samples where the surgeon was confident they could identify areas on the tumor that corresponded to high or low areas of Cu-PET uptake [ Time Frame: Up to 1 year ] [ Designated as safety issue: No ]
    Estimated with a 95% CI half-width of 21%.

  • Pathologic confirmation of Cu-PET 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 SUV positive or negative cases [ Time Frame: Up to 1 year ] [ Designated as safety issue: No ]
    Correlative 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 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Diagnostic (copper Cu 64-DOTA-trastuzumab PET scan)
Patients undergo copper Cu 64-DOTA-trastuzumab PET scan.
Radiation: copper Cu 64-DOTA-trastuzumab
Undergo Copper Cu 64-DOTA-trastuzumab PET scan
Other Name: 64Cu-DOTA-trastuzumab
Device: positron emission tomography
Undergo Copper Cu 64-DOTA-trastuzumab PET scan
Other Names:
  • FDG-PET
  • PET
  • PET scan
  • tomography, emission computed
Other: laboratory biomarker analysis
Correlative studies

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patient must have a histologic diagnosis of gastric or gastroesophageal junction adenocarcinoma; (the first 2 patients must be HER2 3+ by immunohistochemistry [IHC] or fluorescence in situ hybridization [FISH] positive)
  • 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
  • All subjects must have the ability to understand and the willingness to sign a written informed consent
  • For patients that have received prior therapy: 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 for 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
  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 Not yet recruiting
Duarte, California, United States, 91010
Contact: Vincent Chung    626-471-9200    vchung@coh.org   
Principal Investigator: Vincent Chung         
Sponsors and Collaborators
City of Hope Medical Center
Investigators
Principal Investigator: Vincent Chung City of Hope Medical Center
  More Information

No publications provided

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: March 20, 2014
Health Authority: United States: Federal Government

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
Copper
Trastuzumab
Trace Elements
Micronutrients
Growth Substances
Physiological Effects of Drugs
Pharmacologic Actions
Antineoplastic Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on August 28, 2014