Neoadjuvant Weekly Ixabepilone for High Risk, Clinically Localized Prostate Cancer

NCT ID: NCT00828308

Last Updated: 2022-03-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 16 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-02-28
• Study Completion Date: 2016-12-31

Brief 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)

Detailed 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.

Conditions

Prostate Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Ixabepilone

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

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

Group Type: EXPERIMENTAL

Ixabepilone

Intervention Type: DRUG

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

Prostatectomy

Intervention Type: PROCEDURE

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

Interventions

Ixabepilone

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

Intervention Type: DRUG

Prostatectomy

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

Intervention Type: PROCEDURE

Other Intervention Names

Ixempra; Prostatectomy 2-8 weeks after completion ***this was standard of care and not a part of the study**

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

Rhode Island Hospital

OTHER

Sponsor Role: collaborator

The Miriam Hospital

OTHER

Sponsor Role: collaborator

Brown University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Howard Safran, MD

Role: STUDY_CHAIR

BrUOG Study Chair

Locations

Miriam Hospital

Providence, Rhode Island, United States

Countries

United States

Related Links

http://meetinglibrary.asco.org/content/89343-116

ASCO abstract

Other Identifiers

BrUOG-Pros-221

Identifier Type: -

Identifier Source: org_study_id