Neoadjuvant Weekly Ixabepilone for High Risk, Clinically Localized Prostate Cancer

Prostate Cancer Clinical Trial

Official title:

BrUOG-PROS-221 Neoadjuvant Weekly Ixabepilone for High Risk, Clinically Localized Prostate Cancer: A Phase II Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00828308
• Other study ID #: BrUOG-Pros-221
• Status: Completed
• Phase: Phase 2
• Start date: February 2009
• Est. completion date: December 2016

Study information

• Verified date: February 2022
• Source: Brown University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Ixabepilone, 16 mg/m2 or 20mg/m2, weekly x 3, in 4 week cycles, x 4 cycles.

Prostatectomy 2-8 weeks after completion(standard of care and not a part of study)

Description:

Ixabepilone, 16 mg/m2 or 20mg/m2, weekly x 3, in 4 week cycles, x 4 cycles. Prostatectomy 2-8 weeks after completion of chemotherapy (this was standard of care).

This protocol evaluated weekly ixabepilone prior to robotic prostatectomy for patients with high risk localized prostate cancer. PSA response rate, tumor margin status and pathologic responses were assessed.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 16
• Est. completion date: December 2016
• Est. primary completion date: March 2011
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Histologic documentation of prostatic adenocarcinoma. Patients with small cell, neuroendocrine or transitional cell carcinomas are not eligible.

• All eligible patients must have a known Gleason sum based on biopsy or TURP at the time of registration.

• Clinically Localized Disease: Patients must have clinical stage T1-T3a and no radiographic evidence of metastatic disease as demonstrated by:

• Either CT or MRI of the abdomen and pelvis, that demonstrate no nodes > 1 cm: or endorectal MRI(If one or more lymph nodes(s) measures > 1 cm, a negative biopsy is required.)

• Negative bone scan (with plain films and /or MRI and/or CT scan confirmation, if necessary).(Positive PET and Prostascint scans are not considered proof of metastatic disease.)

• Patients must have high risk disease defined as either:

• Gleason Score 8-10

• PSA > 15 ng/ml

• Stage T3a

• Stage T2c and Gleason score of 7

• Stage T2b, Gleason score of 7, greater than 50% of the cores positive from a single lobe.

• No prior treatment for prostate cancer including prior surgery (excluding TURP), pelvic lymph node dissection, radiation therapy, chemotherapy or hormone therapy.

• Patient must be appropriate candidates for radical prostatectomy with an estimated life expectancy > 10 years as determined by an urologist.

• ECOG PS 0-1

• Age > 18 years of age.

• Required initial laboratory values:

• ANC > 1500/ul

• Platelet count > 100,000/mm3

• Creatinine < 2.0 mg/dl

• Serum PSA < 100 ng/ml

• Bilirubin < upper institutional limit of normal (ULN)

• AST/ALT < 2.5 X ULN

Exclusion Criteria:

• Active or uncontrolled infection.

• Patients must not have other coexistent medical condition that would preclude protocol therapy.

• Previous severe hypersensitivity reaction to a drug formulated in CremophoreL (polyoxyethylated castor oil).

• Grade 1 or greater neuropathy (motor or sensory) at study entry

Related Conditions & MeSH terms

• Prostate Cancer
• Prostatic Neoplasms

Intervention

Drug:
• Ixabepilone
Ixabepilone, 16 mg/m2 or 20mg/m2, weekly x 3, in 4 week cycles, x 4 cycles.

Procedure:
• Prostatectomy
Prostatectomy 2-8 weeks after completion ***this was standard of care and not a part of the study**

Locations

Country	Name	City	State
United States	Miriam Hospital	Providence	Rhode Island

Sponsors (3)

Lead Sponsor	Collaborator
Brown University	Rhode Island Hospital, The Miriam Hospital

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Prostate-Specific Antigen (PSA) Response	Decrease in PSA:number of participants with decreased serum PSA level after 12 weeks of ixabepilone	after 12 weeks of ixabepilone

External Links

•   ASCO abstract