Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 1 of 1 for:    NCT00919035
Previous Study | Return to List | Next Study

Single Agent Temsirolimus (Torisel®) in Chemotherapy-naïve Castration-Resistant Prostate Cancer Patients

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.
 
ClinicalTrials.gov Identifier: NCT00919035
Recruitment Status : Completed
First Posted : June 11, 2009
Results First Posted : April 7, 2014
Last Update Posted : June 30, 2014
Sponsor:
Collaborator:
Wyeth is now a wholly owned subsidiary of Pfizer
Information provided by (Responsible Party):
Dr. Sigrun Hallmeyer, Oncology Specialists, S.C.

Tracking Information
First Submitted Date  ICMJE June 10, 2009
First Posted Date  ICMJE June 11, 2009
Results First Submitted Date  ICMJE February 28, 2014
Results First Posted Date  ICMJE April 7, 2014
Last Update Posted Date June 30, 2014
Study Start Date  ICMJE June 2009
Actual Primary Completion Date February 2013   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 19, 2014)
Overall Clinical Benefit From Torisel® in Chemotherapy-naïve Castration Resistant Prostate Cancer (CRPC). [ Time Frame: disease progression is assessed every 2 cycles, for up to 40weeks, per protocol, from the date of the first dose of study drug to the date the patient is taken off study ]
The overall clinical benefit is defined as the sum of complete response (CR), partial response (PR), and stable disease (SD). CR: is the disappearance of all measurable lesions including bone lesions detected on the bone scan, no evidence of new lesions, and no disease-related symptoms. PR: More than 30% decrease in the sum of longest diameter of measurable lesions compared to baseline. SD: Lesions should have no sufficient decrease for PR or CR and no sufficient increase to meet criteria for Progressive Disease (PD). PD: > 20% increase in the sum of longest diameter of measurable lesions compared to baseline, and/or evidence of new lesions on imaging studies OR The appearance of 2 or more new bony lesions on a bone scan is satisfactory for PD. Newly developed cord compression or pathologic fracture is defined as PD.
Original Primary Outcome Measures  ICMJE
 (submitted: June 10, 2009)
To determine the overall clinical benefit with Torisel® in chemotherapy-naïve CRPC. The overall clinical benefit is defined as the sum of complete response, partial response, and stable disease [ Time Frame: disease progression is assessed every 2 cycles ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: June 19, 2014)
  • Time to Disease Progression [ Time Frame: Disease progression is assessed every 2 months, for up to 40 weeks, measured from day one of protocol treatment until the date the patient is off study. ]
    Time to disease progression is defined as the length of time from when the patient starts the study till disease progression. Disease progression is defined as more than 20% increase in the sum of longest diameter of measurable lesions compared to baseline, and/or evidence of new lesions on imaging studies. Or the appearance of 2 or more new bony lesions on a bone scan. Or newly developed cord compression or pathologic fracture.
  • Does the Prostate Specific Antigen (PSA) Doubling Times Change Before and After Treatment [ Time Frame: evaluate PSA doubling time pre study to actual doubling time while on study - calculated from start of study up to 10 cycles or 40 weeks. ]
    PSA Doubling time is defined as the length of time that it takes for an individual patients PSA to double. PSA doubling times were calculated using the medial records at study entry for each patient. While the patient was on study their PSA doubling times were also calculated.
Original Secondary Outcome Measures  ICMJE
 (submitted: June 10, 2009)
  • To evaluate the time to disease progression [ Time Frame: Proportion of patients alive at 1, 2 and 3 years ]
  • To investigate the toxicity and tolerability using the NCI CTCAE criteria [ Time Frame: throughout the time the patient is on study ]
  • To evaluate the time to systemic chemotherapy and time to alternative therapy [ Time Frame: actual day patient starts next treatment ]
  • To assess the changes in PSA doubling time before and after treatment [ Time Frame: evaluate time frame using dates and actual PSA values ]
  • Biochemical responses measured by serum PSA changes [ Time Frame: Using actual PSA values and dates from start of study - lasting through out study ]
  • Proportion of patients alive at 1, 2, & 3 years [ Time Frame: use actual data ]
  • Impact of treatment on quality of life (QOL) and pain scores using the MDASI & BPI published scales [ Time Frame: baseline, C3 & C5 ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Single Agent Temsirolimus (Torisel®) in Chemotherapy-naïve Castration-Resistant Prostate Cancer Patients
Official Title  ICMJE Phase II Study Investigating the Toxicity and Efficacy of Single Agent Temsirolimus (Torisel®) in Chemotherapy-naïve Castration-Resistant Prostate Cancer Patients
Brief Summary This is a single institution, open label, phase II study in androgen-independent prostate cancer patients who are chemotherapy-naïve. Patients will receive Torisel® 25 mg weekly. Treatment continues until disease progression, patient's withdrawal, unacceptable toxicity or the investigator's discretion.
Detailed Description

This is an open label phase II study conducted in patients who have androgen-independent and castration-resistant prostate cancer but who have not received systemic chemotherapy. Investigational therapy such as vaccines, immunotherapy, and some oral targeted agents are NOT considered chemotherapy. Prior use of steroids is not an exclusion criterion.

Patients who meet the inclusion criteria will be allowed to participate. Enrolled patients will receive single agent Torisel® at 25 mg weekly. Every 4 weeks of therapy will constitute one cycle of treatment. Patients will continue on therapy until voluntary withdrawal, toxicity, progression, or the investigator's discretion. Patients will be followed for 3 years after discontinuation of Torisel®.

Patients are allowed to receive intravenous or oral bisphosphonates for their bone metastases and are advised to continue androgen blockade while on study.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Prostate Cancer
Intervention  ICMJE Drug: torisel
Patients will receive Torisel 25 mg weekly. Treatment continues until disease progression, patient's withdrawal, unacceptable toxicity or the investigator's discretion
Other Name: Temsirolimus
Study Arms  ICMJE Experimental: Torisel
Single Agent Temsirolimus (Torisel®)
Intervention: Drug: torisel
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: February 28, 2014)
21
Original Estimated Enrollment  ICMJE
 (submitted: June 10, 2009)
24
Actual Study Completion Date  ICMJE October 2013
Actual Primary Completion Date February 2013   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. Understand and voluntarily sign an informed consent form.
  2. Age 18 years at the time of signing the informed consent form.
  3. Able to adhere to the study visit schedule and other protocol requirements.
  4. Documented prostate cancer regardless of the Gleason score
  5. Patients should be considered hormone refractory and castration-resistant. They must fail LHRH analogues, and anti-androgen withdrawal trial. Failure is confirmed by an increase in PSA value of 10% or more than the value immediately before.
  6. Patients must have measurable disease either biochemically (using PSA) and/or using the Response Evaluation Criteria in Solid Tumors (RECIST) criteria for visceral organ involvement and/or bone disease. If there is no disease to follow on scans a PSA value of at least 5 ng per milliliter needs to be present at baseline to be evaluated for PSA response.
  7. Eastern Cooperative Oncology Group (ECOG) Performance Status of 2 or less.
  8. Adequate liver function tests with ALT/AST being < 3x normal, total bilirubin of 1.5 or less, and adequate renal function measured by a creatinine of 2.0 mg/dl or less. Alkaline phosphatase values are never exclusion criteria if it is deemed related to bone metastases.
  9. Patients need to have adequate bone marrow function.

    • absolute neutrophil count (ANC) of 1000 or above,
    • Hgb of 9.0 g/dl or above,
    • Platelets of 100,000 or above. If other causes are affecting plts counts such as autoimmune disorders, patients are allowed on study. Patients with inadequate bone marrow function that is deemed related to bone marrow involvement with prostate cancer (cytopenias are due to extensive marrow infiltration with prostate cancer) are allowed at the investigator's discretion.
  10. Patients with other malignancies are allowed as long as there is no evidence of the other malignancy present at entry time, and it has been 3 years or more since the treatment for the other disorder was completed. Patients with non-melanoma skin cancers are allowed to participate in the study.
  11. Investigational therapy such as vaccines, immunotherapy, and oral targeted agents are allowed on this study as long as their last exposure was 4 weeks prior to study entry. These agents are not considered an exclusion criteria as they are not considered standard chemotherapy.
  12. Patients with known bone metastases are allowed to receive intravenous bisphosphonates such as aredia or zometa. Patients on oral bisphosphonates are also allowed.
  13. All study participants are encouraged to continue androgen deprivation with an LHRH analogue.
  14. Patients must agree to use a latex condom during sexual contact with a female of childbearing potential, even if they have had a successful vasectomy and despite the fact that they are on androgen deprivation.
  15. Last treatment for prostate cancer should be at least 4 weeks ago

Exclusion Criteria:

  1. Prior systemic chemotherapy for castration Resistant Prostate Cancer (CRPC)
  2. Prior exposure to temsirolimus (TEM)
  3. Known HIV positive status or infectious hepatitis, type A, B, or C.
  4. Known brain metastases.
  5. Steroids are allowed concomitantly ONLY IF they are taken for another chronic medical condition (Such as chronic obstructive pulmonary disease , Multiple sclerosis…etc)
  6. Any serious medical condition, laboratory abnormality, or psychiatric illness that would prevent the subject from signing and understanding the informed consent form.
  7. Any condition, including the presence of laboratory abnormalities, which places the subject at unacceptable risk if he were to participate in the study or confounds the ability to interpret data from the study.
  8. Use of any other experimental drug or therapy within 28 days of baseline.
Sex/Gender  ICMJE
Sexes Eligible for Study: Male
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00919035
Other Study ID Numbers  ICMJE OSRI 0901
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Dr. Sigrun Hallmeyer, Oncology Specialists, S.C.
Study Sponsor  ICMJE Oncology Specialists, S.C.
Collaborators  ICMJE Wyeth is now a wholly owned subsidiary of Pfizer
Investigators  ICMJE
Principal Investigator: Chadi Nabhan, MD Oncology Specialists, S.C.
PRS Account Oncology Specialists, S.C.
Verification Date June 2014

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