Neoadjuvant Weekly Ixabepilone for High Risk, Clinically Localized Prostate Cancer
Study Details
Study Description
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)
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 2 |
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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: 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*** |
Drug: Ixabepilone
Ixabepilone, 16 mg/m2 or 20mg/m2, weekly x 3, in 4 week cycles, x 4 cycles.
Other Names:
Procedure: Prostatectomy
Prostatectomy 2-8 weeks after completion ***this was standard of care and not a part of the study**
Other Names:
|
Outcome Measures
Primary Outcome Measures
- Prostate-Specific Antigen (PSA) Response [after 12 weeks of ixabepilone]
Decrease in PSA:number of participants with decreased serum PSA level after 12 weeks of ixabepilone
Eligibility Criteria
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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Miriam Hospital | Providence | Rhode Island | United States | 02906 |
Sponsors and Collaborators
- Brown University
- Rhode Island Hospital
- The Miriam Hospital
Investigators
- Study Chair: Howard Safran, MD, BrUOG Study Chair
Study Documents (Full-Text)
None provided.More Information
Additional Information:
Publications
None provided.- BrUOG-Pros-221
Study Results
Participant Flow
| Recruitment Details | First patient enrolled 2/11/09 and last patient enrolled was 3/30/11 |
|---|---|
| Pre-assignment Detail |
| Arm/Group Title | Ixabepilone |
|---|---|
| Arm/Group 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. |
| Period Title: Overall Study | |
| STARTED | 16 |
| COMPLETED | 16 |
| NOT COMPLETED | 0 |
Baseline Characteristics
| Arm/Group Title | Ixabepilone |
|---|---|
| Arm/Group Description | Ixabepilone, 16 mg/m2, weekly x 3, in 4 week cycles, x 4 cycles. Prostatectomy 2-8 weeks after completion of chemotherapy (this was standard of care and not a part of the study) |
| Overall Participants | 16 |
| Age (Count of Participants) | |
| <=18 years |
0
0%
|
| Between 18 and 65 years |
12
75%
|
| >=65 years |
4
25%
|
| Age (years) [Mean (Standard Deviation) ] | |
| Mean (Standard Deviation) [years] |
56.5
(29)
|
| Sex: Female, Male (Count of Participants) | |
| Female |
0
0%
|
| Male |
16
100%
|
| Region of Enrollment (participants) [Number] | |
| United States |
16
100%
|
Outcome Measures
| Title | Prostate-Specific Antigen (PSA) Response |
|---|---|
| Description | Decrease in PSA:number of participants with decreased serum PSA level after 12 weeks of ixabepilone |
| Time Frame | after 12 weeks of ixabepilone |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | Ixabepilone |
|---|---|
| Arm/Group Description | Ixabepilone, 16 mg/m2 or 20mg/m2, weekly x 3, in 4 week cycles, x 4 cycles. Prostatectomy will occur 2-8 weeks after completion of chemotherapy. |
| Measure Participants | 16 |
| Number [participants] |
14
87.5%
|
Adverse Events
| Time Frame | Toxicities collected during treatment and approximately 30 days post last dose of drug (approximately 5 months). Of note, the adverse events posted are all AEs patient's experienced and do not equate to toxicities confirmed as related to treatment. | |
|---|---|---|
| Adverse Event Reporting Description | ||
| Arm/Group Title | Ixabepilone | |
| Arm/Group Description | Ixabepilone, 16 mg/m2 or 20mg/m2, weekly x 3, in 4 week cycles, x 4 cycles. Prostatectomy will occur 2-8 weeks after completion of chemotherapy. | |
All Cause Mortality |
||
| Ixabepilone | ||
| Affected / at Risk (%) | # Events | |
| Total | / (NaN) | |
Serious Adverse Events |
||
| Ixabepilone | ||
| Affected / at Risk (%) | # Events | |
| Total | 1/16 (6.3%) | |
| Investigations | ||
| pneumonia (3) with normal ANC, post infuection bronchitis (3), wheezing (3) | 1/16 (6.3%) | 1 |
Other (Not Including Serious) Adverse Events |
||
| Ixabepilone | ||
| Affected / at Risk (%) | # Events | |
| Total | 16/16 (100%) | |
| Investigations | ||
| Constipation | 6/16 (37.5%) | 6 |
| nasuea | 3/16 (18.8%) | 3 |
| neuorapthy | 13/16 (81.3%) | 13 |
| fatigue | 11/16 (68.8%) | 11 |
| diarrhea | 7/16 (43.8%) | 7 |
| taste alteration | 3/16 (18.8%) | 3 |
| heartburn | 1/16 (6.3%) | 1 |
| pain | 1/16 (6.3%) | 1 |
| dehydration | 3/16 (18.8%) | 3 |
| insomnia | 4/16 (25%) | 4 |
| wt loss | 3/16 (18.8%) | 3 |
| rash/pruritus | 2/16 (12.5%) | 2 |
| anorexia | 1/16 (6.3%) | 1 |
| hyperpigmentation | 1/16 (6.3%) | 1 |
| abdominal cramping/pain | 4/16 (25%) | 4 |
| dysphagia | 1/16 (6.3%) | 1 |
| urinary frequency | 2/16 (12.5%) | 2 |
| allergic reaction/hypersensitivity reaction | 3/16 (18.8%) | 3 |
| edema | 1/16 (6.3%) | 1 |
| rhinitis | 2/16 (12.5%) | 2 |
| depression | 1/16 (6.3%) | 1 |
| infection | 4/16 (25%) | 4 |
| alopecia | 5/16 (31.3%) | 5 |
| HTN | 1/16 (6.3%) | 1 |
| shortness of breath | 1/16 (6.3%) | 1 |
| headache | 1/16 (6.3%) | 1 |
| muscle aches/myalgia | 2/16 (12.5%) | 2 |
| wheezing | 1/16 (6.3%) | 1 |
| cough | 1/16 (6.3%) | 1 |
| WBC | 1/16 (6.3%) | 1 |
| ANC | 1/16 (6.3%) | 1 |
| HGB | 2/16 (12.5%) | 2 |
| pain-joint | 1/16 (6.3%) | 1 |
| sore throat | 3/16 (18.8%) | 3 |
| flushing | 1/16 (6.3%) | 1 |
| flatulence | 1/16 (6.3%) | 1 |
| mood | 1/16 (6.3%) | 1 |
| pain-mouth | 1/16 (6.3%) | 1 |
| pain-muscle | 1/16 (6.3%) | 1 |
| hoarseness | 1/16 (6.3%) | 1 |
Limitations/Caveats
More Information
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
| Name/Title | Anthony Mega, MD |
|---|---|
| Organization | BrUOG |
| Phone | 4018633000 |
| BrUOG@brown.edu |
- BrUOG-Pros-221