Phase II Study Investigating the Toxicity and Efficacy of Single Agent Temsirolimus (Torisel®) in Chemotherapy-naïve Castration-Resistant Prostate Cancer Patients
Overview
- Phase
- Phase 2
- Intervention
- torisel
- Conditions
- Prostate Cancer
- Sponsor
- Oncology Specialists, S.C.
- Enrollment
- 21
- Locations
- 2
- Primary Endpoint
- Overall Clinical Benefit From Torisel® in Chemotherapy-naïve Castration Resistant Prostate Cancer (CRPC).
- Status
- Completed
- Last Updated
- 11 years ago
Overview
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.
Investigators
Dr. Sigrun Hallmeyer
Director of Research
Oncology Specialists, S.C.
Eligibility Criteria
Inclusion Criteria
- •Understand and voluntarily sign an informed consent form.
- •Age 18 years at the time of signing the informed consent form.
- •Able to adhere to the study visit schedule and other protocol requirements.
- •Documented prostate cancer regardless of the Gleason score
- •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.
- •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.
- •Eastern Cooperative Oncology Group (ECOG) Performance Status of 2 or less.
- •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.
- •Patients need to have adequate bone marrow function.
- •absolute neutrophil count (ANC) of 1000 or above,
Exclusion Criteria
- •Prior systemic chemotherapy for castration Resistant Prostate Cancer (CRPC)
- •Prior exposure to temsirolimus (TEM)
- •Known HIV positive status or infectious hepatitis, type A, B, or C.
- •Known brain metastases.
- •Steroids are allowed concomitantly ONLY IF they are taken for another chronic medical condition (Such as chronic obstructive pulmonary disease , Multiple sclerosis...etc)
- •Any serious medical condition, laboratory abnormality, or psychiatric illness that would prevent the subject from signing and understanding the informed consent form.
- •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.
- •Use of any other experimental drug or therapy within 28 days of baseline.
Arms & Interventions
Torisel
Single Agent Temsirolimus (Torisel®)
Intervention: torisel
Outcomes
Primary Outcomes
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.
Secondary Outcomes
- Does the Prostate Specific Antigen (PSA) Doubling Times Change Before and After Treatment(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.)
- Time to Disease Progression(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.)