Neoadjuvant CCI-779 Followed By Radical Prostatectomy in Treating Patients With Newly Diagnosed Prostate Cancer Who Have a High Risk of Relapse

Plain-language summary

This study looks at the drug temsirolimus (CCI-779) given before surgery (radical prostatectomy) in patients newly diagnosed with prostate cancer who have a high risk of relapse. It enrolled patients aged 18 and older with organ-confined disease who were candidates for surgery. The research was conducted in Phase 2 and has been completed.

The summary above is a plain-language rendering of the official record. The original English title is shown for reference.

Trial details

Phase

Phase 2

Status

Completed

Sponsor

Jonsson Comprehensive Cancer Center

Intervention

temsirolimus, conventional surgery, neoadjuvant therapy

Start date

8/1/2003

Countries

United States

Related genes

Locations

• Los Angeles, United States

Eligibility criteria

Criteria are reproduced from the ClinicalTrials.gov record in the original English. Only the trial team can determine eligibility.

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