Efficacy Study of [F-18]RGD-K5 Positron Emission Tomography (PET) as a Tool to Monitor Response to an Anti-angiogenic Drug

Summary

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

Timeline

Start

2009-09

Primary completion

2012-03

Completion

2012-05

Drugs

Indications