Status:
COMPLETED
Docetaxel, Androgen Ablation, and External-Beam Radiation Therapy in Patients With High-Risk Localized Prostate Cancer
Lead Sponsor:
UNC Lineberger Comprehensive Cancer Center
Collaborating Sponsors:
Sanofi
Conditions:
Prostate Cancer
Eligibility:
MALE
18-120 years
Phase:
PHASE1
PHASE2
Brief Summary
RATIONALE: Drugs used in chemotherapy, such as docetaxel, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Androgens can cause t...
Detailed Description
OBJECTIVES: Primary * Determine the dose-limiting toxicity and maximum tolerated dose of docetaxel when administered in combination with androgen ablation therapy and adaptive external-beam radiothe...
Eligibility Criteria
Inclusion
- Histologically confirmed adenocarcinoma of the prostate with any of following clinical features:
- A) T3 or T4 B) T1-2 + Gleason Score 8-10 C) T1-2 + Gleason Score 7 + Prostate Specific Antigen (PSA) \>10 ng/mL D) T1-2 + Any Gleason Score + PSA \>20 ng/mL
- No evidence of metastatic disease on chest x-ray, bone scan or CT scan of abdomen/pelvis.
- Age \> 18
- The Eastern Cooperative Oncology Group (ECOG) Performance Status 0-1
- Peripheral neuropathy: must be \< grade 1
- Hematologic parameters A) Absolute neutrophil count \> 1,500/mm3 B) Hemoglobin \> 8.0 g/dL C) Platelet count \> 100,000/mm3.
- Hepatic parameters / Renal function A) Total Bilirubin must be ≤ 1.2 mg/dL B) Transaminases (AST and ALT) must be \< 1.5 x upper limit of normal (ULN) C) Alkaline phosphatase must be \< 2.5 x ULN D) Creatinine \< 1.5 x ULN ( \< 2.1 mg/dL)
- No prior pelvic or prostate radiation or chemotherapy for prostate cancer. Androgen ablation therapy with one of the luteinizing hormone-releasing hormone (LH-RH) agonists prior to enrollment is acceptable as long as protocol treatment with radiotherapy and chemotherapy is started within 3 months of the initiation of androgen ablation.
- Patient must be willing to consent to using effective contraception while on treatment and for at least 3 months thereafter.
Exclusion
- Documented metastases on staging studies
- Life expectancy \<10 years secondary to co-morbid illness
- Myocardial infarction or significant change in anginal pattern within one year prior to study entry or current congestive heart failure (New York Heart Association Class 2 or higher)
- Patients with a history of severe hypersensitivity reaction to docetaxel or other drugs formulated with polysorbate 80
- History of invasive malignancy within the last five years prior to study entry except for carcinoma in situ or nonmelanoma skin cancer.
- Psychiatric conditions which would prevent compliance with treatment or adequate informed consent.
- Patients receiving another investigational agent during chemo- and radiotherapy
- Uncontrolled intercurrent illness or other conditions that limit compliance with protocol treatment
Key Trial Info
Start Date :
August 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2012
Estimated Enrollment :
23 Patients enrolled
Trial Details
Trial ID
NCT00225420
Start Date
August 1 2005
End Date
August 1 2012
Last Update
June 1 2017
Active Locations (2)
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1
Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill
Chapel Hill, North Carolina, United States, 27599-7295
2
Rex Cancer Center at Rex Hospital
Raleigh, North Carolina, United States, 27607