Clinical trial NCT00828308: Neoadjuvant Weekly Ixabepilone for High Risk, Clinically Localized Prostate Cancer
Official title: BrUOG-PROS-221 Neoadjuvant Weekly Ixabepilone for High Risk, Clinically Localized Prostate Cancer: A Phase II Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Prostate Cancer
Keywords: localized
high risk
prostate cancer
neoadjuvant treatment
Lead sponsor: Brown University
Sponsor class: OTHER
Collaborators: name: Rhode Island Hospital
name: The Miriam Hospital
First posted: 2009-01-23
Enrollment: 16
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Prostate-Specific Antigen (PSA) Response
timeFrame: after 12 weeks of ixabepilone
Secondary outcomes:
Other outcomes:
Locations:
city: Providence
country: United States
facility: Miriam Hospital
state: Rhode Island
Study officials:
affiliation: BrUOG Study Chair
name: Howard Safran, MD
role: STUDY_CHAIR
References: