Everolimus (RAD001, Afinitor®) and Cyclophosphamide in Castration and Docetaxel resistant Prostate Cancer, a proof of principle Phase II study. - Metronomic treatment of castration resistant prostate cancer

ederlands Kanker Instituut0 个研究点目标入组 20 人开始时间: 待定最近更新: 2024年5月6日

研究概览

暂无简介。

•- Prostate cancer diagnosis and a rising PSA under castrate serum testosterone levels (2 rises
•in a period of at least 3 months), PSA > 10ng/ml.
•- At least one prior cycle of Docetaxel treatment.
•- ECOG performance status 0-2.
•- Locally accessible prostate cancer for TRUS-guided biopsies.
•- Written informed consent.
•- Laboratory requirements:
•a) Hematology:
•* Hemoglobin > 5 mmol/L
•* Platelet count * 100,000/*L
•* No leucopenia
•b) Hepatic function:
•* AST and ALT * 2.5 times upper limit of normal (ULN)
•* Bilirubin * 1.5 times ULN
•c) Renal function:
•* Calculated GFR (Cockroft) * 60 ml/min
•* PT/PTT normal (no anticoagulants)
•- Fertile patients must use effective contraception during and for 6 months after completion of
•study therapy.

•- Small cell pathology.
•- Allergy to Everolimus or cyclophosphamide or components of Afinitor ® or Endoxan ®.
•- Co-medication interfering with CYP3A4 activity.
•- Gastrointestinal (GI) disease, condition, or symptoms that may significantly impair GI function
•and alter the absorption of Everolimus, including any of the following:
•o Ulcerative disease
•o Malabsorption syndrome
•- Other active malignancy or malignancy at * 30% risk for relapse after completion of therapy,
•except nonmelanoma skin cancer .
•- Recent (within 2 weeks) surgery.
•- Uncontrolled concurrent illness including, but not limited to, any of the following:
•o Ongoing or active infection (e.g., bacterial, viral or fungal)
•o Severely impaired lung function
•o Uncontrolled diabetes (fasting serum glucose > 1.5 times ULN)
•o Liver disease (e.g., cirrhosis, chronic active hepatitis, or chronic persistent hepatitis)
•o Symptomatic congestive heart failure
•o Unstable angina pectoris
•o Cardiac arrhythmia
•- Lower urinary tract obstruction not treated with bladder catheterisation.

发起方

ederlands Kanker Instituut