Docetaxel formulation in hormone-refractory prostate cancer patients

• Research type

  Research Study

• Full title

  A Pharmacokinetic and Safety Study of a New Docetaxel GP-Pharm Formulation (Polysorbate-free) Compared to Standard Reference Taxotere in Patients With Hormone-refractory Prostate Cancer (HRPC) or Biochemical Progression (Rising Prostate-specific Antigen [PSA]) During Androgenic Suppression Therapy

• IRAS ID

  26287

• Contact name

  Isabel Syndikus

• Eudract number

  2009-013016-13

• ISRCTN Number

  Not available

• Research summary

  For many years the benefit of chemotherapy in prostate cancer was thought to be limited to relieving symptoms of advanced disease. However, recent studies have shown that chemotherapy can prolong survival among men with hormone-refractory (not responding to hormone treatment) prostate cancer. Docetaxel is the preferred option for most of these patients. Docetaxel is commercially available as Taxotere. Taxotere involves mixing two liquids before preparing an infusion. The new formulation being studied (Docetaxel GP-Pharm) comes ready to be prepared as an infusion. The purpose of this study is to demonstrate the two formulations are equal in the way the body absorbs, distributes, breaks down and gets rid of the drug. This will be the first time Docetaxel GP-Pharm is given to patients so the study will also determine safety of the formulation. The study involves four 21-day cycles with a 60-minute infusion on the first day of each cycle. Participants will be assigned to one of two treatment arms. There is 50% chance of being assigned to each arm. Participants in the first arm will receive Taxotere for the first cycle and Docetaxel GP-Pharm for the three remaining cycles. Participants in the other arm will receive Docetaxel GP-Pharm for the first cycle and Taxotere for the three remaining cycles. During the first two cycles, blood samples will be taken at various time-points on the day of dosing and 24 and 48 hours after completion of dosing. Participants will also attend for safety assessments one and two weeks after dosing. For the last two cycles, safety assessments will be completed on the day of dosing and one and two weeks after dosing. After the study, patients can be offered Taxotere as standard of care. This study is sponsored by GP-Pharm SA. Approximately 30 patients will be enrolled in Austria, Belgium, Germany, Spain and the UK.

• REC name

  North East - York Research Ethics Committee

• REC reference

  09/H0903/39

• Date of REC Opinion

  10 Aug 2009

• REC opinion

  Further Information Favourable Opinion