Trial Outcomes & Findings for Single Agent Temsirolimus (Torisel®) in Chemotherapy-naïve Castration-Resistant Prostate Cancer Patients (NCT NCT00919035)

NCT ID: NCT00919035

Last Updated: 2014-06-30

Results Overview

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.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

21 participants

Primary outcome timeframe

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

Results posted on

2014-06-30

Participant Flow

Participant milestones

Participant milestones
Measure	Torisel Single Agent Temsirolimus (Torisel®) torisel: Patients will receive Torisel 25 mg weekly. Treatment continues until disease progression, patient's withdrawal, unacceptable toxicity or the investigator's discretion
Overall Study STARTED	21
Overall Study COMPLETED	21
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Torisel n=21 Participants Single Agent Temsorilmus (Torisel®) Patients will receive Torisel 25 mg weekly given as an intravenous infusion on days 1, 8, 15 and 33 every 28 days. Treatment continues until disease progression, patient's withdrawal, unacceptable toxicity or the investigator's discretion
Age, Categorical <=18 years	0 Participants n=93 Participants
Age, Categorical Between 18 and 65 years	4 Participants n=93 Participants
Age, Categorical >=65 years	17 Participants n=93 Participants
Sex: Female, Male Female	0 Participants n=93 Participants
Sex: Female, Male Male	21 Participants n=93 Participants
Region of Enrollment United States	21 participants n=93 Participants

PRIMARY outcome

Timeframe: 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

Outcome measures

Outcome measures
Measure	Torisel n=15 Participants Single Agent Temsirolimus (Torisel®) Patients will receive Torisel 25 mg weekly given as an intravenous infusion on days 1, 8, 15 and 33 every 28 days. Treatment continues until disease progression, patient's withdrawal, unacceptable toxicity or the investigator's discretion
Overall Clinical Benefit From Torisel® in Chemotherapy-naïve Castration Resistant Prostate Cancer (CRPC).	67 percentage of participants

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Torisel n=15 Participants Single Agent Temsirolimus (Torisel®) Patients will receive Torisel 25 mg weekly given as an intravenous infusion on days 1, 8, 15 and 33 every 28 days. Treatment continues until disease progression, patient's withdrawal, unacceptable toxicity or the investigator's discretion
Time to Disease Progression	2 months Interval 2.0 to 10.0

SECONDARY outcome

Timeframe: 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.

Population: PSA doubling time pre study was compared to PSA doubling time while the patients are on study, per protocol.

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.

Outcome measures

Outcome measures
Measure	Torisel n=14 Participants Single Agent Temsirolimus (Torisel®) Patients will receive Torisel 25 mg weekly given as an intravenous infusion on days 1, 8, 15 and 33 every 28 days. Treatment continues until disease progression, patient's withdrawal, unacceptable toxicity or the investigator's discretion
Does the Prostate Specific Antigen (PSA) Doubling Times Change Before and After Treatment	0 percentage of participants

Adverse Events

Torisel

Serious events: 11 serious events

Other events: 21 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Torisel n=21 participants at risk Single Agent Temsirolimus (Torisel®) Patients will receive Torisel 25 mg weekly given as an intravenous infusion on days 1, 8, 15 and 33 every 28 days. Treatment continues until disease progression, patient's withdrawal, unacceptable toxicity or the investigator's discretion
Blood and lymphatic system disorders Anemia	4.8% 1/21 • Number of events 1 • Adverse events were recorded from the start of the study until study completion. This is from May 2009 until October 2013.
Vascular disorders Acute Arterial ischemia	4.8% 1/21 • Number of events 1 • Adverse events were recorded from the start of the study until study completion. This is from May 2009 until October 2013.
Metabolism and nutrition disorders dehydration	4.8% 1/21 • Number of events 1 • Adverse events were recorded from the start of the study until study completion. This is from May 2009 until October 2013.
Vascular disorders Deep Vein Thrombosis	4.8% 1/21 • Number of events 1 • Adverse events were recorded from the start of the study until study completion. This is from May 2009 until October 2013.
Infections and infestations fever	4.8% 1/21 • Number of events 1 • Adverse events were recorded from the start of the study until study completion. This is from May 2009 until October 2013.
Vascular disorders intracranial bleed	4.8% 1/21 • Number of events 1 • Adverse events were recorded from the start of the study until study completion. This is from May 2009 until October 2013.
General disorders pain	19.0% 4/21 • Number of events 4 • Adverse events were recorded from the start of the study until study completion. This is from May 2009 until October 2013.
General disorders pneumonia	14.3% 3/21 • Number of events 3 • Adverse events were recorded from the start of the study until study completion. This is from May 2009 until October 2013.
Renal and urinary disorders renal failure	4.8% 1/21 • Number of events 1 • Adverse events were recorded from the start of the study until study completion. This is from May 2009 until October 2013.
Respiratory, thoracic and mediastinal disorders shortness of breath	4.8% 1/21 • Number of events 1 • Adverse events were recorded from the start of the study until study completion. This is from May 2009 until October 2013.
Vascular disorders transient ischemic attack	4.8% 1/21 • Number of events 1 • Adverse events were recorded from the start of the study until study completion. This is from May 2009 until October 2013.
Renal and urinary disorders urinary retention	4.8% 1/21 • Number of events 1 • Adverse events were recorded from the start of the study until study completion. This is from May 2009 until October 2013.
Renal and urinary disorders urinary tract infection	9.5% 2/21 • Number of events 2 • Adverse events were recorded from the start of the study until study completion. This is from May 2009 until October 2013.
General disorders weakness	9.5% 2/21 • Number of events 2 • Adverse events were recorded from the start of the study until study completion. This is from May 2009 until October 2013.

Other adverse events

Other adverse events
Measure	Torisel n=21 participants at risk Single Agent Temsirolimus (Torisel®) Patients will receive Torisel 25 mg weekly given as an intravenous infusion on days 1, 8, 15 and 33 every 28 days. Treatment continues until disease progression, patient's withdrawal, unacceptable toxicity or the investigator's discretion
Musculoskeletal and connective tissue disorders arthralgia	9.5% 2/21 • Number of events 2 • Adverse events were recorded from the start of the study until study completion. This is from May 2009 until October 2013.
Psychiatric disorders anxiety	23.8% 5/21 • Number of events 5 • Adverse events were recorded from the start of the study until study completion. This is from May 2009 until October 2013.
Metabolism and nutrition disorders albumin low	38.1% 8/21 • Number of events 8 • Adverse events were recorded from the start of the study until study completion. This is from May 2009 until October 2013.
Blood and lymphatic system disorders anemia	71.4% 15/21 • Number of events 15 • Adverse events were recorded from the start of the study until study completion. This is from May 2009 until October 2013.
Metabolism and nutrition disorders anorexia	52.4% 11/21 • Number of events 11 • Adverse events were recorded from the start of the study until study completion. This is from May 2009 until October 2013.
General disorders alkaline phosphatase	28.6% 6/21 • Number of events 6 • Adverse events were recorded from the start of the study until study completion. This is from May 2009 until October 2013.
General disorders Aspartate Aminotransferase elevated	38.1% 8/21 • Number of events 8 • Adverse events were recorded from the start of the study until study completion. This is from May 2009 until October 2013.
General disorders Alanine Aminotransferase high	9.5% 2/21 • Number of events 2 • Adverse events were recorded from the start of the study until study completion. This is from May 2009 until October 2013.
Vascular disorders bruising	9.5% 2/21 • Number of events 2 • Adverse events were recorded from the start of the study until study completion. This is from May 2009 until October 2013.
Respiratory, thoracic and mediastinal disorders cough	19.0% 4/21 • Number of events 4 • Adverse events were recorded from the start of the study until study completion. This is from May 2009 until October 2013.
Renal and urinary disorders creatinine high	33.3% 7/21 • Number of events 7 • Adverse events were recorded from the start of the study until study completion. This is from May 2009 until October 2013.
Gastrointestinal disorders constipation	42.9% 9/21 • Number of events 9 • Adverse events were recorded from the start of the study until study completion. This is from May 2009 until October 2013.
General disorders chills	9.5% 2/21 • Number of events 2 • Adverse events were recorded from the start of the study until study completion. This is from May 2009 until October 2013.
Psychiatric disorders depression	28.6% 6/21 • Number of events 6 • Adverse events were recorded from the start of the study until study completion. This is from May 2009 until October 2013.
Gastrointestinal disorders dehydration	9.5% 2/21 • Number of events 2 • Adverse events were recorded from the start of the study until study completion. This is from May 2009 until October 2013.
Gastrointestinal disorders diarrhea	9.5% 2/21 • Number of events 2 • Adverse events were recorded from the start of the study until study completion. This is from May 2009 until October 2013.
Respiratory, thoracic and mediastinal disorders dyspnea on exertion	9.5% 2/21 • Number of events 2 • Adverse events were recorded from the start of the study until study completion. This is from May 2009 until October 2013.
Eye disorders eyes dry	9.5% 2/21 • Number of events 2 • Adverse events were recorded from the start of the study until study completion. This is from May 2009 until October 2013.
Eye disorders eyes watery	14.3% 3/21 • Number of events 3 • Adverse events were recorded from the start of the study until study completion. This is from May 2009 until October 2013.
Vascular disorders edema	33.3% 7/21 • Number of events 7 • Adverse events were recorded from the start of the study until study completion. This is from May 2009 until October 2013.
General disorders fall	9.5% 2/21 • Number of events 2 • Adverse events were recorded from the start of the study until study completion. This is from May 2009 until October 2013.
General disorders fatigue	71.4% 15/21 • Number of events 15 • Adverse events were recorded from the start of the study until study completion. This is from May 2009 until October 2013.
Infections and infestations fever	9.5% 2/21 • Number of events 2 • Adverse events were recorded from the start of the study until study completion. This is from May 2009 until October 2013.
General disorders gynecomastia	9.5% 2/21 • Number of events 2 • Adverse events were recorded from the start of the study until study completion. This is from May 2009 until October 2013.
General disorders hypercholesteremia	38.1% 8/21 • Number of events 8 • Adverse events were recorded from the start of the study until study completion. This is from May 2009 until October 2013.
General disorders hypercalcemia	14.3% 3/21 • Number of events 3 • Adverse events were recorded from the start of the study until study completion. This is from May 2009 until October 2013.
General disorders hyperglycemia	66.7% 14/21 • Number of events 14 • Adverse events were recorded from the start of the study until study completion. This is from May 2009 until October 2013.
General disorders hypertriglyceridemia	66.7% 14/21 • Number of events 14 • Adverse events were recorded from the start of the study until study completion. This is from May 2009 until October 2013.
Renal and urinary disorders hematuria	9.5% 2/21 • Number of events 2 • Adverse events were recorded from the start of the study until study completion. This is from May 2009 until October 2013.
General disorders hypoglycemia	4.8% 1/21 • Number of events 1 • Adverse events were recorded from the start of the study until study completion. This is from May 2009 until October 2013.
General disorders hypocalcemia	42.9% 9/21 • Number of events 9 • Adverse events were recorded from the start of the study until study completion. This is from May 2009 until October 2013.
General disorders hypokalemia	23.8% 5/21 • Number of events 5 • Adverse events were recorded from the start of the study until study completion. This is from May 2009 until October 2013.
General disorders hyponatremia	28.6% 6/21 • Number of events 6 • Adverse events were recorded from the start of the study until study completion. This is from May 2009 until October 2013.
General disorders hypophosphatemia	23.8% 5/21 • Number of events 5 • Adverse events were recorded from the start of the study until study completion. This is from May 2009 until October 2013.
General disorders hemorrhoids	9.5% 2/21 • Number of events 2 • Adverse events were recorded from the start of the study until study completion. This is from May 2009 until October 2013.
Metabolism and nutrition disorders hypoalbuminemia	9.5% 2/21 • Number of events 2 • Adverse events were recorded from the start of the study until study completion. This is from May 2009 until October 2013.
Infections and infestations infection	9.5% 2/21 • Number of events 2 • Adverse events were recorded from the start of the study until study completion. This is from May 2009 until October 2013.
General disorders insomnia	14.3% 3/21 • Number of events 3 • Adverse events were recorded from the start of the study until study completion. This is from May 2009 until October 2013.
General disorders lightheadedness	4.8% 1/21 • Number of events 1 • Adverse events were recorded from the start of the study until study completion. This is from May 2009 until October 2013.
General disorders leukopenia	71.4% 15/21 • Number of events 15 • Adverse events were recorded from the start of the study until study completion. This is from May 2009 until October 2013.
General disorders lymphopenia	61.9% 13/21 • Number of events 13 • Adverse events were recorded from the start of the study until study completion. This is from May 2009 until October 2013.
General disorders mucositis	23.8% 5/21 • Number of events 5 • Adverse events were recorded from the start of the study until study completion. This is from May 2009 until October 2013.
General disorders neutropenia	57.1% 12/21 • Number of events 12 • Adverse events were recorded from the start of the study until study completion. This is from May 2009 until October 2013.
Nervous system disorders neuropathy	28.6% 6/21 • Number of events 6 • Adverse events were recorded from the start of the study until study completion. This is from May 2009 until October 2013.
Gastrointestinal disorders nausea	19.0% 4/21 • Number of events 4 • Adverse events were recorded from the start of the study until study completion. This is from May 2009 until October 2013.
Metabolism and nutrition disorders protein low	9.5% 2/21 • Number of events 2 • Adverse events were recorded from the start of the study until study completion. This is from May 2009 until October 2013.
General disorders pain	38.1% 8/21 • Number of events 8 • Adverse events were recorded from the start of the study until study completion. This is from May 2009 until October 2013.
Skin and subcutaneous tissue disorders rash	33.3% 7/21 • Number of events 7 • Adverse events were recorded from the start of the study until study completion. This is from May 2009 until October 2013.
General disorders rectal fissure	9.5% 2/21 • Number of events 2 • Adverse events were recorded from the start of the study until study completion. This is from May 2009 until October 2013.
Respiratory, thoracic and mediastinal disorders shortness of breath	9.5% 2/21 • Number of events 2 • Adverse events were recorded from the start of the study until study completion. This is from May 2009 until October 2013.
Metabolism and nutrition disorders taste changes	14.3% 3/21 • Number of events 3 • Adverse events were recorded from the start of the study until study completion. This is from May 2009 until October 2013.
Blood and lymphatic system disorders thrombocytopenia	76.2% 16/21 • Number of events 16 • Adverse events were recorded from the start of the study until study completion. This is from May 2009 until October 2013.
Gastrointestinal disorders vomting	14.3% 3/21 • Number of events 3 • Adverse events were recorded from the start of the study until study completion. This is from May 2009 until October 2013.
General disorders weight loss	28.6% 6/21 • Number of events 6 • Adverse events were recorded from the start of the study until study completion. This is from May 2009 until October 2013.
General disorders weakness	9.5% 2/21 • Number of events 2 • Adverse events were recorded from the start of the study until study completion. This is from May 2009 until October 2013.

Additional Information

Sigrun Hallmeyer, MD

Oncolgy Specialists, SC

Phone: 847-268-8200

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place