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Neoadjuvant CCI-779 Followed By Radical Prostatectomy in Treating Patients With Newly Diagnosed Prostate Cancer Who Have a High Risk of Relapse
Bu çalışma, yeni prostat kanseri (prostate cancer) tanısı almış ve nüks (hastalığın tekrarlama) riski yüksek hastalarda, ameliyattan (radikal prostatektomi) önce uygulanan temsirolimus (CCI-779) ilacının etkisini incelemektedir. Çalışmaya, organa sınırlı hastalığı olan ve ameliyata uygun 18 yaş ve üzeri hastalar alınmıştır. Araştırma Faz 2 aşamasında yürütülmüş ve tamamlanmıştır.
Yukarıdaki özet, resmî kaydın sade dile aktarılmış halidir. Orijinal İngilizce başlık referans için gösterilir.
Kriterler ClinicalTrials.gov kaydından orijinal İngilizce haliyle alınmıştır. Uygunluk kararını yalnızca deneyi yürüten ekip verebilir.
DISEASE CHARACTERISTICS:
* Histologically confirmed adenocarcinoma of the prostate
* Diagnosis based on a minimum of 6 core biopsy samples
* Clinically confirmed organ-confined disease
* Candidate for radical prostatectomy
* No evidence of metastatic disease by CT scan and bone scan
* High risk of relapse based on either of the following criteria:
* Any one of the following:
* Stage T2C or higher
* Gleason score greater than 7
* Prostate-specific antigen (PSA) greater than 20 ng/mL OR
* Any two of the following:
* Gleason score at least 7
* PSA 10-20 ng/mL
* Greater than 50% of total biopsy cores with cancer involvement
PATIENT CHARACTERISTICS:
Age
* 18 and over
Performance status
* ECOG 0-1
Life expectancy
* Not specified
Hematopoietic
* No active bleeding
* Absolute neutrophil count at least 1,500/mm\^3
* Platelet count at least 100,000/mm\^3
* Hemoglobin at least 10 g/dL
Hepatic
* No acute or chronic hepatitis B
* Hepatitis B surface antigen negative
* No acute or chronic hepatitis C
* No antibodies to hepatitis C
* Bilirubin no greater than 1.5 times upper limit of normal (ULN)
* AST and ALT no greater than 2 times ULN
Renal
* No ongoing urinary tract infection necessitating rapid or emergent surgical resection
* Creatinine no greater than 1.5 times ULN
Cardiovascular
* No unstable angina
* No myocardial infarction within the past 6 months
* No life-threatening ventricular arrhythmia requiring ongoing maintenance therapy
Pulmonary
* No known pulmonary hypertension
* No pneumonitis
Other
* Fertile patients must use effective contraception during and for 12 weeks after study participation
* HIV negative
* No other severe immunocompromised states
* No active infection requiring antibiotic therapy
* No serious concurrent illness
* No other major illness that would substantially increase the risk associated with study participation
* No other malignancy within the past 5 years except basal cell or squamous cell skin cancer
PRIOR CONCURRENT THERAPY:
Biologic therapy
* No concurrent immunotherapy
Chemotherapy
* No prior chemotherapy
* No other concurrent chemotherapy
Endocrine therapy
* More than 3 weeks since prior IV corticosteroids
* No concurrent systemic corticosteroids
* No prior or concurrent hormonal therapy for underlying malignancy
Radiotherapy
* No prior or concurrent radiotherapy
Surgery
* More than 3 months since prior major surgery
Other
* More than 1 month since prior experimental drugs
* More than 3 weeks since prior immunosuppressive agents
* No concurrent immunosuppressive therapies
* No other concurrent investigational agents
* No concurrent enzyme-inducing anticonvulsants (e.g., phenobarbital, phenytoin, or carbamazepine)
* No concurrent ketoconazole, diltiazem, rifampin, terfenadine, cisapride, astemizole, pimozide, or Hypericum perforatum (St. John's wort)
* No concurrent grapefruit or grapefruit juice