Status:
COMPLETED
Neoadjuvant Weekly Ixabepilone for High Risk, Clinically Localized Prostate Cancer
Lead Sponsor:
Brown University
Collaborating Sponsors:
Rhode Island Hospital
The Miriam Hospital
Conditions:
Prostate Cancer
Eligibility:
MALE
18+ years
Phase:
PHASE2
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 ixabep...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
February 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2016
Estimated Enrollment :
16 Patients enrolled
Trial Details
Trial ID
NCT00828308
Start Date
February 1 2009
End Date
December 1 2016
Last Update
March 8 2022
Active Locations (1)
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1
Miriam Hospital
Providence, Rhode Island, United States, 02906