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

NCT00071968 | Completed Phase 2

• 3 other identifiers: CDR0000331979UCLA-0306091WYETH-C-3066A1-132-US
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

Brief Summary

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

Prostate Cancer

Keywords

adenocarcinoma of the prostate; stage IIB prostate cancer; stage IIA prostate cancer; stage I prostate cancer

Outcome Measures

Primary Outcomes (4)

• Phosphorylation state of proteins

• p70S6 kinase activity

• Phosphorylation state of mTOR pathway proteins

• Global and targeted gene expression patterns in peripheral blood mononuclear cells

Secondary Outcomes (6)

• Global and targeted gene expression patterns

• Pharmacodynamics and pharmacogenomic surrogate markers

• Antitumor effects

• Pharmacokinetics

• Correlation of phosphatase and tensin homolog gene status with pharmacodynamic and pharmacogenomic effects

Interventions

temsirolimus DRUG

conventional surgery PROCEDURE

neoadjuvant therapy PROCEDURE

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Jonsson Comprehensive Cancer Center: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

Jonsson Comprehensive Cancer Center at UCLA

Los Angeles, California, 90095-1738, United States

Location

Related Publications (1)

• Thomas 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.

  RESULT

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

temsirolimus; Neoadjuvant Therapy

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Combined Modality Therapy; Therapeutics

Study Officials

• Charles Sawyers, MD

  Jonsson Comprehensive Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: November 4, 2003
• First Posted: November 6, 2003
• Study Start: August 1, 2003
• Primary Completion: May 1, 2006
• Last Updated: January 8, 2013

Record last verified: 2013-01

Locations

US (1)