Efficacy Study of [F-18]RGD-K5 Positron Emission Tomography (PET) as a Tool to Monitor Response to an Anti-angiogenic Drug
NCT ID: NCT00988936
Last Updated: 2012-08-22
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
35 participants
INTERVENTIONAL
2009-09-30
2012-05-31
Brief Summary
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The primary objective for this study is:
* To explore the usefulness of \[F-18\]RGD-K5 PET/CT to predict efficacy or early response to Avastin® (the anti-angiogenesis drug) plus chemotherapy treatment before the full course of treatment is completed
The secondary objectives for this study are:
* To continue safety evaluation by collection of safety data from all patients
* To gain experience with \[F-18\]RGD-K5 PET/CT in order to improve the study design and conduct of future studies
Design: An open label, non-randomized, uncontrolled, single group assignment, pilot efficacy study
Duration: Screening visit (3-4 hrs), pre-treatment imaging visit of \[F-18\]RGD-K5 PET/CT (\~ 3-4 hrs) and the standard \[F-18\]FDG PET/CT (\~ 3-4 hrs) or diagnostic CT, followed by two \[F-18\]RGD-K5 PET/CT scans, one after the second but before the third Avastin® treatment, and one after the fourth but before the fifth Avastin® treatment, and a follow up standard \[F-18\]FDG PET (\~ 3-4 hrs) or diagnostic CT.
Procedures: Informed consent, collection of demographic information, medical history, blood labs, physical examination, vital signs, ECGs, three sets of \[F-18\]RGD-K5 dosing and imaging scans including pretreatment, early mid-treatment, and later mid-treatment, concomitant medication collection, adverse event monitoring, and assessment of tumor response to treatment
Patients: Approximately forty (40) patients with non-squamous non-small cell lung cancer, metastatic breast cancer, metastatic colon or rectum cancer who will receive chemotherapy plus Avastin®. This allows for approximately 30 evaluable patients to complete this study at approximately four to eight sites internationally
Detailed Description
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Conditions
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Keywords
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
NONE
Study Groups
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[F-18]RDG-K5
[F-18]RGD-K5
Approximately forty (40) patients with non-squamous non-small cell lung cancer, metastatic breast cancer, metastatic colon or rectum cancer will receive chemotherapy plus Avastin® and will be imaged under PET/CT with \[F-18\]RGD-K5
Interventions
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[F-18]RGD-K5
Approximately forty (40) patients with non-squamous non-small cell lung cancer, metastatic breast cancer, metastatic colon or rectum cancer will receive chemotherapy plus Avastin® and will be imaged under PET/CT with \[F-18\]RGD-K5
Eligibility Criteria
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Inclusion Criteria
* Patient or patient's legally acceptable representative provides written informed consent and willing to comply with protocol requirements
* Patient must be scheduled to receive chemotherapy treatment(s) plus Avastin® for their cancer care; treatment management will be made by the treating medical oncologists (According to the package insert for Avastin®, it is administered as an IV infusion every 3 weeks for nonsquamous non-small cell lung cancer, and every 2 weeks for metastatic breast cancer, colon or rectum cancer)
* Patient will be scheduled to have a clinical \[F-18\]FDG-PET/CT or diagnostic CT pre-treatment after the fourth but before the fifth Avastin® treatment
Exclusion Criteria
* Female patient is pregnant or nursing; exclude the possibility of pregnancy by one of the following:
* Confirming in medical history that the patient is postmenopausal for a minimum of one year, or surgically sterile
* Confirming the patient is using one of the following methods of birth control for a minimum of one month prior to entry into this study: IUD, oral contraceptives, Depo-Provera, or Norplant
* Confirming a negative urine dipstick test taken the morning of receiving the \[F-18\]RGD-K5
* Patient has a severe hepatic or renal disease as defined by previous medical history or abnormal renal and hepatic functions determined by lab results not within the following ranges, or in the opinion of the Investigator, the values are not acceptable for the patient to be included:
* AST (SGOT)/ALT (SGPT) ≤ 2.5 x institutional upper limits of normal
* Serum creatinine ≤ 2x institutional upper limits of normal
* BUN within 2x institutional upper limits of normal
* Patient has known hyper or hypo-coagulation syndromes. (e.g. Protein C, S deficiency, Hemophilia A/B/C, Factor-V Leiden, etc) or lab results are not within the following ranges, or in the opinion of the Investigator, the values are not acceptable for the patient to be included: Platelet counts of \< 75 x 103/μL
* Patient has known sensitivity to any components of Avastin® such as recombinant human or humanized antibodies
* Patient has been involved in an investigative, radioactive research procedure within 7 days and during the study participation period
* Patient will participate in experimental therapy procedures while participating in this clinical trial
* Patient has any other condition or personal circumstance that, in the judgment of the investigator, might interfere with the collection of complete data or data quality to achieve study objectives, or complete study and/or post-dose follow-up examinations
18 Years
ALL
No
Sponsors
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Siemens Molecular Imaging
INDUSTRY
Responsible Party
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Principal Investigators
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Edward Aten, MD
Role: STUDY_DIRECTOR
President, Certus International
Locations
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University of California, Irvine
Irvine, California, United States
Cedars-Sinai Medical Center
Los Angeles, California, United States
UMDNJ
Newark, New Jersey, United States
Beth Israel Medical Center
New York, New York, United States
Mount Sinai School of Medicine
New York, New York, United States
Hospital of University of Pennsylvania
Philadelphia, Pennsylvania, United States
Fox Chase Cancer Center
Philadelphia, Pennsylvania, United States
Eastern Regional Medical Center
Philadelphia, Pennsylvania, United States
Countries
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Other Identifiers
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K5-101
Identifier Type: -
Identifier Source: org_study_id