Metastatic Breast Cancer Clinical Trial
Official title:
A Phase II, Open Label, Non-randomized, Multi-center, Pilot, Efficacy Study of [F-18]RGD-K5 Positron Emission Tomography (PET) as a Tool to Monitor Response to an Anti-angiogenic Drug
A Pilot Phase II Study
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
The aim of this pilot study is to examine the utility of a new molecular imaging tracer, [F-18]RGD-K5 to monitor treatment responses in patients scheduled to undergo treatment with Avastin® (Bevacizumab) plus standard chemotherapy. The changes of [F-18]RGD-K5 PET/CT image scans between before treatment and after both mid-treatment cycles of Avastin® (Bevacizumab) will be evaluated. The hypothesis for this study is that changes in the uptake of [F-18]RGD-K5 PET in tumors may reflect changes in the level of integrin expression and/or angiogenesis. This pilot study will help to define if changes in uptake of [F-18]RGD-K5 are an early indicator of treatment efficacy to Avastin®. ;
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