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

This study has been completed.
Sponsor:
Collaborator:
Wyeth is now a wholly owned subsidiary of Pfizer
Information provided by (Responsible Party):
Dr. Sigrun Hallmeyer, Oncology Specialists, S.C.
ClinicalTrials.gov Identifier:
NCT00919035
First received: June 10, 2009
Last updated: June 19, 2014
Last verified: June 2014
  Purpose

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.


Condition Intervention Phase
Prostate Cancer
Drug: torisel
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Phase II Study Investigating the Toxicity and Efficacy of Single Agent Temsirolimus (Torisel®) in Chemotherapy-naïve Castration-Resistant Prostate Cancer Patients

Resource links provided by NLM:


Further study details as provided by Oncology Specialists, S.C.:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • 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. ] [ Designated as safety issue: No ]
    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. ] [ Designated as safety issue: No ]
    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.


Enrollment: 21
Study Start Date: June 2009
Study Completion Date: October 2013
Primary Completion Date: February 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Torisel
Single Agent Temsirolimus (Torisel®)
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

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00919035

Locations
United States, Illinois
Oncology Specialists, SC
Niles, Illinois, United States, 60714
Oncology Specialists, S.C.
Park Ridge, Illinois, United States, 60068
Sponsors and Collaborators
Oncology Specialists, S.C.
Wyeth is now a wholly owned subsidiary of Pfizer
Investigators
Principal Investigator: Chadi Nabhan, MD Oncology Specialists, S.C.
  More Information

No publications provided

Responsible Party: Dr. Sigrun Hallmeyer, Director of Research, Oncology Specialists, S.C.
ClinicalTrials.gov Identifier: NCT00919035     History of Changes
Other Study ID Numbers: OSRI 0901
Study First Received: June 10, 2009
Results First Received: February 28, 2014
Last Updated: June 19, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Oncology Specialists, S.C.:
prostate cancer
androgen-independent prostate cancer (AIPC) Prostate Cancer

Additional relevant MeSH terms:
Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases
Sirolimus
Everolimus
Anti-Bacterial Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Antibiotics, Antineoplastic
Antineoplastic Agents
Antifungal Agents
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on August 01, 2014