Status:
COMPLETED
Cabazitaxel With Radiation and Hormone Therapy for Prostate Cancer
Lead Sponsor:
Sidney Kimmel Cancer Center at Thomas Jefferson University
Collaborating Sponsors:
Sanofi
Conditions:
Prostate Cancer
Eligibility:
MALE
18+ years
Phase:
PHASE1
Brief Summary
This is a single-center, open-label, non-randomized Phase I study of weekly Cabazitaxel with concurrent intensity modulated radiation therapy (IMRT) (A type of 3-dimensional radiation therapy that use...
Detailed Description
Patients with locally advanced high Gleason grade prostate cancer often have local and metastatic disease progression. To improve on these outcomes, therapy needs to be directed at controlling the and...
Eligibility Criteria
Inclusion
- Adenocarcinoma of the prostate with locally advanced prostate cancer without distant metastatic with unfavorable risk features that are defined below:
- Gleason score ≥8
- Gleason score 7 and T3/T4 disease
- Gleason score 7 but PSA ≥20
- Karnofsky Performance Status \>70,
- Age \> 18
- Performance Status: ECOG ≤2
- Peripheral neuropathy: must be \< grade 1
- Hematologic (minimal values):
- Absolute neutrophil count \> 1,500/mm3
- Hemoglobin \> 8.0 g/dl
- Platelet count \> 100,000/mm3
- Hepatic function
- Total bilirubin \< Upper limit of normal (ULN)(except for Gilbert's disease)
- AST (SGOT) \< 1.5 x ULN
- ALT (SGPT) \< 1.5 x ULN
- Creatinine \< 1.5 x ULN
- Men of childbearing potential must be willing to consent to using effective contraception while on treatment and for at least 3 months thereafter.
- No history of previous chemotherapy or pelvic irradiation
Exclusion
- Patients with a history of severe hypersensitivity reaction to Cabazitaxel or other drugs formulated with polysorbate 80.
- History of urological surgery or procedures predisposing to GU complications after radiation (will be determined by radiation oncologist)
- History of diverticulitis, rectal bleeding or other lower GI diseases predisposing to GI complications after radiation (will be determined by radiation oncologist)
- History of prior chemotherapy or pelvic irradiation,
- History of prior invasive malignant cancer(s) within the last 5 years except adequately treated or controlled basal cell or squamous cell carcinoma of the skin
- Documented distant metastatic disease.
- Prior radical prostatectomy or cryosurgery for prostate cancer or bilateral orchiectomy
Key Trial Info
Start Date :
September 22 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 21 2020
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT01420250
Start Date
September 22 2011
End Date
July 21 2020
Last Update
May 15 2025
Active Locations (1)
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1
Thomas Jefferson University
Philadelphia, Pennsylvania, United States, 19107