Clinical trial · Interventional
Neoadjuvant CCI-779 Followed By Radical Prostatectomy in Treating Patients With Newly Diagnosed Prostate Cancer Who Have a High Risk of Relapse
An Open-Label Study Of Exploratory Pharmacogenomics And Pharmacologic Effects Of Neoadjuvant Oral CCI-779 In Newly Diagnosed Prostate Cancer Patients Undergoing Radical Prostatectomy Who Have A High Risk Of Relapse
NCT00071968CI-TRIAL-00008815completedPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
RATIONALE: Drugs used in chemotherapy, such as CCI-779, work in different ways to stop tumor cells from dividing so they stop growing or die. Giving CCI-779 before surgery may shrink the tumor so that it can be removed. PURPOSE: This randomized phase II trial is studying how well CCI-779 works in treating patients who are undergoing radical prostatectomy for newly diagnosed prostate cancer at high risk of relapse.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Prostate Cancer | Malignant Prostate Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| conventional surgery | Procedure | — | UNRESOLVED |
| neoadjuvant therapy | Procedure | — | UNRESOLVED |
| temsirolimus | Drug | Temsirolimus | ALIAS |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (4)
- measure
- Phosphorylation state of proteins
- measure
- p70S6 kinase activity
- measure
- Phosphorylation state of mTOR pathway proteins
- measure
- Global and targeted gene expression patterns in peripheral blood mononuclear cells
Secondary outcomes (6)
- measure
- Global and targeted gene expression patterns
- measure
- Pharmacodynamics and pharmacogenomic surrogate markers
- measure
- Antitumor effects
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
Show eligibility criteria text
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 juiceReferences
Publications (1)
- RESULTThomas G, Speicher L, Reiter R, et al.: Demonstration that temsirolimus preferentially inhibits the mTOR pathway in the tumors of prostate cancer patients with PTEN deficiencies. [Abstract] Clin Cancer Res 11 (Suppl 24): A-C131, 2005.