ZYBRESTAT (Combretastatin / CA4P) Phase II in Advanced Platinum-Resistant Ovarian Cancer

A Phase II Trial of CA4P in Combination with Carboplatin and Paclitaxel Chemotherapy in Patients with Advanced Platinum-Resistant Ovarian Cancer.

This study is being conducted at six centers in the United Kingdom. The study will enroll approximately 43 patients with advanced platinum-resistant ovarian or closely related cancers (specifically primary peritoneal or fallopian tube cancer) who have relapsed within six months following first-line treatment with a platinum-containing chemotherapy regimen. All participants will receive ZYBRESTAT, carboplatin and paclitaxel.

This study is designed as a two-stage study, in which a pre-specified efficacy criterion must be achieved in the first stage of the study in order for the study to progress and continue to enroll patients in the second stage. On December 31, 2007, OXiGENE reported that the study had achieved this pre-specified efficacy criterion and would progress to the second stage and enroll further patients. (See the press releases section of this website for further information.)

Selected Entry Criteria

In order to participate in the study, you must:

• Be 18 years of age or older.
• Have advanced ovarian, fallopian tube or primary peritoneal cancer already treated with a chemotherapy regimen that included cisplatin or carboplatin.
• Be strong enough to be able to walk, take care of your basic personal needs (such as dressing, toileting), and to be out of bed at least half your waking hours (for physicians, this means ECOGPerformance Score ≤ 2).
• Have adequate function of liver and kidneys.
• Have an adequate blood count.
• At least four weeks must have elapsed since your last chemotherapy, immunotherapy or radiotherapy.

Patients with brain metastasis may not participate.

Clinical Centers - United Kingdom

Gordon Rustin, M.D.
Mount Vernon Hospital
Northwood, Middlesex
United Kingdom
T: +44 1923 844 190

Bass Hassan, M.D.
Oxford Radcliffe Hospitals
Headington, Oxford
United Kingdom
T: +44 1865 226 190

Gordon Jayson, M.D.
Christie Hospital
Withington, Manchester
United Kingdom
T: +44 1614 463 606

Richard Osborne, M.D.
Poole Hospital
Poole, Dorset
United Kingdom
T: +44 1202 448 265

Nick Reed, M.D.
Beatson Oncology Centre
Western Infirmary
Glangous
United Kingdom
T: +44 1412 111 764

David Parkin, M.D.
Aberdeen Royal Infirmary
Aberdeen
United Kingdom
T: +44 1224 551 283