PROCEED Trial in Participants with Ovarian Cancer
Research type
Research Study
Full title
A Randomized, Double-Blind Phase 3 Trial Comparing EC145 and Pegylated Liposomal Doxorubicin (PLD/DOXIL®/CAELYX®) in Combination Versus PLD in Participants with Platinum-Resistant Ovarian Cancer.
IRAS ID
96415
Contact name
Jonathan A Ledermann
Sponsor organisation
Endocyte, Inc.
Eudract number
2011-000348-11
Clinicaltrials.gov Identifier
Research summary
Ovarian cancer is a significant cause of mortality. Patients usually respond to chemotherapy but the disease recurs and is harder to treat. Chemotherapy with PLD (liposomal doxorubicin [Caelyx]) is commonly used to treat recurrent ovarian cancer, but its benefit is limited. New treatments are needed and EC145 is being studied in this trial. This drug targets the folate receptor (FR), a molecule on the surface of a cell important for its function. FRs are found in more than 90% of ovarian cancers. EC145 is a drug attached to the targeting molecule which is delivered to the tumour cell and is highly damaging. In clinical Studies, EC145 has already shown to have anti-tumour effect in ovarian cancer and has been well tolerated without the toxicity of standard chemotherapy. In a randomised study with EC145 and PLD, there was a significant delay in disease progression compared to standard PLD therapy. Thus the addition of EC145 to PLD could be a significant treatment option providing rationale for this trial with PLD in ovarian cancer. The study needs to be repeated to confirm the benefit in a larger group. Approximately 640 patients will take part internationally with about 23 patients from the UK. Patients are expected to participate up to 20 months and beyond if the cancer is reducing. For targeted therapies it is important to co-develop diagnostic tests to establish the presence of the molecular target. This allows better selection of patients for more efficient and effective treatment. The Imaging agent EC20 identifies active FRs; clinical studies have shown EC20 is safe and can identify suitable patients. Patients will have SPECT imaging with Radiolabelled EC20 to identify participants who could benefit from EC145 treatment. EC20 has been given to over 558 people and has shown to be safe and extremely well-tolerated. Patients will receive treatment of their cancer with clinical and radiological assessment, evaluation of toxicity and measurement of quality of life. Endocyte, Inc. is the study sponsor.
REC name
London - Dulwich Research Ethics Committee
REC reference
12/LO/0980
Date of REC Opinion
2 Oct 2012
REC opinion
Further Information Favourable Opinion