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

NCT00919035 | Completed Phase 2 Results DMC

• 1 other identifier: OSRI 0901
• Study Type: interventional
• Target: 21
• Locations: 1 country
• Sites: 2

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.

Conditions

Prostate Cancer

Keywords

prostate cancer; androgen-independent prostate cancer (AIPC) Prostate Cancer

Outcome Measures

Primary Outcomes (1)

• Overall Clinical Benefit From Torisel® in Chemotherapy-naïve Castration Resistant Prostate Cancer (CRPC).

  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.

  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

Secondary Outcomes (2)

• 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.

• 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.

Study Arms (1)

Torisel

EXPERIMENTAL

Single Agent Temsirolimus (Torisel®)

Drug: torisel

Interventions

torisel DRUG

Patients will receive Torisel 25 mg weekly. Treatment continues until disease progression, patient's withdrawal, unacceptable toxicity or the investigator's discretion

Also known as: Temsirolimus

Torisel

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.
• 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.
• Patients with known bone metastases are allowed to receive intravenous bisphosphonates such as aredia or zometa. Patients on oral bisphosphonates are also allowed.
• All study participants are encouraged to continue androgen deprivation with an LHRH analogue.
• 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.
• Last treatment for prostate cancer should be at least 4 weeks ago
• 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.

Sponsors & Collaborators

• Oncology Specialists, S.C.: lead
• Wyeth is now a wholly owned subsidiary of Pfizer: collaborator

Study Sites (2)

Oncology Specialists, SC

Niles, Illinois, 60714, United States

Location

Oncology Specialists, S.C.

Park Ridge, Illinois, 60068, United States

Location

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

temsirolimus

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Results Point of Contact

• Title: Sigrun Hallmeyer, MD
• Organization: Oncolgy Specialists, SC

shallmeyer@oncmed.net

847-268-8200

Study Officials

• Chadi Nabhan, MD

  Oncology Specialists, S.C.

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of Research

Study Record Dates

• First Submitted: June 10, 2009
• First Posted: June 11, 2009
• Study Start: June 1, 2009
• Primary Completion: February 1, 2013
• Study Completion: October 1, 2013
• Last Updated: June 30, 2014
• Results First Posted: April 7, 2014

Record last verified: 2014-06

Locations

US (2)