Phase I trial of Indium-hEGF in metastatic EGFR-positive cancers

• Research type

  Research Study

• Full title

  A Cancer Research UK Phase I activity accumulation trial of [111Indium]-DTPA-hEGF given sequentially by an intravenous infusion in patients with metastatic EGFR-positive cancers.

• IRAS ID

  86150

• Contact name

  Katherine Vallis

• Sponsor organisation

  Cancer Research UK

• Eudract number

  2011-000459-18

• ISRCTN Number

  na

• Research summary

  This clinical study is looking at the effects of [111Indium]-DTPA-hEGF (Indium-hEGF) on patients with EGFR positive cancer (such as breast, gynaecological, lung, head and neck cancer). Indium-hEGF is a targeted radiotherapy drug which means that it targets cells that have too much of a particular protein (a naturally occurring substance in your body called epithelial growth factor receptor or EGFR). Indium-hEGF is a radioactive drug which means that each time the patient receives the drug the patient will be exposed to radiation until the body gets rid of (excretes) it. The three aims of this study are to find out: - The maximum number of doses that can be given safely to patients - More about the potential side effects of the drug and how they can be managed -What happens to Indium-hEGF inside the body. This information will help to decide how much and how often to give Indium-hEGF to patient in future studies. As the study goes on, the number of doses given to people in the study will be increased (as long as there are not too many side effects). The first patient (called Group 1) to be entered into the study will only receive one infusion. Following patients (minimum three patients per group) will receive one infusion on sequential occasions for either two (Group 2), three (Group 3), four (Group 4) or five (Group 5) times. Approximately 19-25 patients will be treated in this study which will be carried out in two hospitals in the UK. The study is expected to take five years to recruit depending on the final number of patients needed.

• REC name

  South Central - Oxford B Research Ethics Committee

• REC reference

  11/SC/0525

• Date of REC Opinion

  12 Jan 2012

• REC opinion

  Further Information Favourable Opinion