We are updating the design of this site. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

Everolimus as First-Line Therapy in Treating Patients With Prostate Cancer

This study is ongoing, but not recruiting participants.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00976755
First Posted: September 14, 2009
Last Update Posted: May 5, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Swiss Group for Clinical Cancer Research
September 11, 2009
September 14, 2009
May 5, 2017
September 14, 2009
November 29, 2012   (Final data collection date for primary outcome measure)
Progression-free survival (PFS) at 12 weeks [ Time Frame: at 12 weeks ]
PFS at 12 weeks is defined as the absence of disease progression or death at 12 weeks after start of treatment.
Progression-free survival at 12 weeks
Complete list of historical versions of study NCT00976755 on ClinicalTrials.gov Archive Site
  • PFS at 24 weeks [ Time Frame: at 24 weeks ]
    PFS at 24 weeks is defined as the absence of any disease progression or death at 24 weeks after start of treatment.
  • Progression-free survival [ Time Frame: from start of treatment until progression or death of any cause ]
    from start of treatment until progression or death of any cause, whereas it will be censored at the last follow-up visit or initiation of a different treatment.
  • Adverse events (AEs) according to NCI CTCAE v. 3.0 [ Time Frame: from start of treatment until progression or death of any cause ]
    All AEs will be assessed according to NCI CTCAE v3.0
  • PSA response [ Time Frame: 50% and 30%, best and at 12 weeks ]

    50% PSA response is defined as a decrease in PSA level of at least 50% (compared to baseline PSA).

    30% PSA response is defined as a decrease in PSA level of at least 30% (compared to baseline PSA).

    Best response is defined as the percentage of change in PSA from baseline to the maximum decline in PSA at any point under treatment.

    Response at 12 weeks is defined as the percentage of change in PSA from baseline to 12 weeks (or earlier for those patients who discontinue therapy, in this case last PSA values recorded should be taken).

  • Changes in PSA-doubling time [ Time Frame: Time points for later calculations include: after 12 weeks, after 24 weeks and at best PSA response ]
    PSA-DT is calculated by natural log of 2 divided by the slope of the relationship between the log of PSA and time of PSA measurement for each patient.
  • Tumor assessment of measurable disease according to RECIST v1.1 criteria [ Time Frame: The first assessment will be performed after 12 weeks of treatment, or earlier if clinically indicated. ]
    For patients with measurable disease at baseline RECIST v1.1 will be used to define CR, PR, SD and PD.
  • Tumor assessment of bone lesions [ Time Frame: at 12 weeks. ]
    Bone metastases can be assessed by radionuclide bone scan.
  • Progression-free survival at 24 weeks
  • Progression-free survival
  • Adverse events according to NCI CTCAE v. 3.0
  • PSA response (50% and 30%, best and at 12 weeks)
  • Changes in PSA-doubling time
  • Tumor assessment of measurable disease according to RECIST v1.1 criteria
  • Tumor assessment of bone lesions
  • Overall survival
Not Provided
Not Provided
 
Everolimus as First-Line Therapy in Treating Patients With Prostate Cancer
Everolimus First-line Therapy in Non-rapidly Progressive Castration Resistant Prostate Cancer (CRPC). A Multicenter Phase II Trial.

RATIONALE: Everolimus may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth and by blocking blood flow to the tumor.

PURPOSE: This phase II trial is studying the side effects of everolimus and to see how well it works as first-line therapy in treating patients with prostate cancer.

OBJECTIVES:

Primary

  • Determine the progression-free survival at 12 weeks of patients with non-rapidly progressive castration-resistant prostate cancer treated with everolimus as first-line therapy.
  • Assess the activity and safety of this regimen in these patients.

Secondary

  • Determine the progression-free survival at 24 weeks of patients treated with this regimen.
  • Determine the percentage of PSA response from baseline to 12 weeks in patients treated with this regimen.
  • Determine the changes in PSA-doubling time in patients treated with this regimen.
  • Determine the overall survival of patients treated with this regimen.

OUTLINE: This is a multicenter study.

Patients receive oral everolimus once daily on days 1-28. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.

After completion of study therapy, patients are followed up at 28 days and then every 3 months.

Interventional
Phase 2
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Prostate Cancer
Drug: everolimus

Everolimus:

10mg daily

Other Names:
  • Afinitor®
  • Votubia®
  • RAD001
Experimental: Arm A: Everolimus

Everolimus:

10mg daily

Intervention: Drug: everolimus

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
37
December 31, 2017
November 29, 2012   (Final data collection date for primary outcome measure)

DISEASE CHARACTERISTICS:

  • Histologically confirmed metastatic or locally advanced adenocarcinoma of the prostate

    • No curative therapy available
    • Oligosymptomatic or asymptomatic patients
  • Tumor progression after ≥ 1 hormonal treatment (orchiectomy or luteinizing-hormone releasing-hormone [LHRH] agonist) with documented total testosterone levels ≤ 1.7 nmol/L (≤ 50 ng/dL)

    • Concurrent LHRH agonist therapy is required for patients who have not been surgically castrated
    • Must have stopped antiandrogen therapy ≥ 6 weeks before the start of trial treatment without withdrawal response
  • PSA progression defined as an increase in PSA ≥ 25% (and an absolute increase of 2 ng/mL or more) over nadir value on hormonal therapy measured on 3 successive occasions ≥ 1 week apart

    • If the third measurement is not higher than the second, a fourth measurement will be taken (patient allowed if the fourth measurement is higher than the second)
    • PSA doubling time ≥ 55 days
  • No known or suspected CNS metastases

PATIENT CHARACTERISTICS:

  • WHO performance status 0-1
  • ANC ≥ 1,500/mm^3
  • Platelet count ≥ 100,000/mm^3
  • Hemoglobin ≥ 90 g/L
  • Bilirubin ≤ 1.5 times upper limit of normal (ULN)
  • AST ≤ 2.5 times ULN
  • Creatinine clearance ≥ 40 mL/min
  • Fasting serum cholesterol ≤ 7.75 mmol/L AND fasting triglycerides ≤ 2.5 times ULN

    • Appropriate lipid-lowering medication allowed in case one or both of these thresholds are exceeded
  • Patient compliance and geographic proximity that would allow proper staging and follow-up are required
  • No malignancy within the past 5 years except curatively treated localized nonmelanoma skin cancer or Ta and Tis bladder cancer
  • No known history of HIV
  • No serologically confirmed hepatitis B or C
  • No serious underlying medical condition that, in the judgment of the investigator, could impair the ability of the patient to participate in the trial including, but not limited to, any of the following conditions:

    • Uncontrolled or acute severe infection
    • Uncontrolled diabetes
    • Advanced chronic obstructive pulmonary disease
  • No psychiatric disorder precluding understanding of information on trial-related topics, giving informed consent, or interfering with compliance for oral drug intake
  • No known hypersensitivity to trial drug or hypersensitivity to any of its components

PRIOR CONCURRENT THERAPY:

  • See Disease Characteristics
  • No prior chemotherapy, radioisotopes, small molecules, immunotherapy, or investigational drug therapy for prostate cancer
  • No local radiotherapy within the past 2 weeks
  • No major surgery within the past 4 weeks
  • No concurrent radiotherapy
  • No concurrent angiotensin converting enzyme inhibitors
  • No concurrent chronic immunosuppressive therapy including high-dose corticosteroids (i.e., > 25 mg prednisone equivalent per day)
  • No products known to affect PSA levels (e.g., PC Calm, PC Plus, PC SPES, finasteride, or fluconazole) within the past 4 weeks or concurrently
  • No strong CYP3A4 inhibitors (e.g., itraconazole, erythromycin, clarithromycin, diltiazem, verapamil, or grapefruit or its juice) within the past 2 weeks or concurrently
  • No strong CYP3A4 inducers (e.g., phenytoin, rifampicin, carbamazepine, phenobarbital, or St. John wort) within the past 2 weeks or concurrently
  • No concurrent bisphosphonates

    • Patients must continue to receive bisphosphonates regularly if it was started prior to entering the trial
  • No concurrent experimental drugs or other anticancer therapy in a clinical trial within the past 30 days
  • No concomitant drugs contraindicated for use with the trial drug according to the investigator's drug brochure
Sexes Eligible for Study: Male
18 Years to 120 Years   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Switzerland
 
 
NCT00976755
SAKK 08/08
SWS-SAKK-08/08
EU-20967
CDR0000649049
No
Not Provided
Plan to Share IPD: No
Swiss Group for Clinical Cancer Research
Swiss Group for Clinical Cancer Research
Not Provided
Principal Investigator: Arnoud Templeton, MD Cantonal Hospital of St. Gallen
Study Chair: Silke Gillessen, MD Cantonal Hospital of St. Gallen
Swiss Group for Clinical Cancer Research
May 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP