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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Swiss Group for Clinical Cancer Research
ClinicalTrials.gov Identifier:
NCT00976755
First received: September 11, 2009
Last updated: December 8, 2013
Last verified: December 2013

September 11, 2009
December 8, 2013
September 2009
August 2010   (final data collection date for primary outcome measure)
Progression-free survival [ Time Frame: at 12 weeks ] [ Designated as safety issue: No ]
Progression-free survival at 12 weeks [ Designated as safety issue: No ]
Complete list of historical versions of study NCT00976755 on ClinicalTrials.gov Archive Site
  • Progression-free survival [ Time Frame: at 24 weeks ] [ Designated as safety issue: No ]
  • Progression-free survival [ Time Frame: from start of treatment until progression or death of any cause ] [ Designated as safety issue: No ]
    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 according to NCI CTCAE v. 3.0 [ Time Frame: from start of treatment until progression or death of any cause ] [ Designated as safety issue: Yes ]
  • PSA response [ Time Frame: 50% and 30%, best and at 12 weeks ] [ Designated as safety issue: No ]
  • Changes in PSA-doubling time [ Time Frame: Time points for later calculations include: after 12 weeks, after 24 weeks and at best PSA response ] [ Designated as safety issue: No ]
  • 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. ] [ Designated as safety issue: No ]
  • Tumor assessment of bone lesions [ Time Frame: at 12 weeks. ] [ Designated as safety issue: No ]
  • Progression-free survival at 24 weeks [ Designated as safety issue: No ]
  • Progression-free survival [ Designated as safety issue: No ]
  • Adverse events according to NCI CTCAE v. 3.0 [ Designated as safety issue: Yes ]
  • PSA response (50% and 30%, best and at 12 weeks) [ Designated as safety issue: No ]
  • Changes in PSA-doubling time [ Designated as safety issue: No ]
  • Tumor assessment of measurable disease according to RECIST v1.1 criteria [ Designated as safety issue: No ]
  • Tumor assessment of bone lesions [ Designated as safety issue: No ]
  • Overall survival [ Designated as safety issue: No ]
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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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 2017
August 2010   (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
Male
18 Years and older
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
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
December 2013

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