Docetaxel, Androgen Ablation, and External-Beam Radiation Therapy in Patients With High-Risk Localized Prostate Cancer

Completed · Phase 1/Phase 2

Conditions studied: Prostate Cancer

In brief

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 the growth of prostate cancer cells. Antihormone therapy, such as leuprolide, may lessen the amount of androgens made by the body. Radiation therapy uses high energy x-rays to kill tumor cells. Giving docetaxel together with androgen ablation therapy and external-beam radiation therapy may kill more tumor cells. PURPOSE: This phase I/II trial is studying the side effects and best dose of docetaxel when given together with androgen ablation therapy and external-beam radiation therapy and to see how well they work in treating patients with high-risk localized prostate cancer.

Key facts

Study ID

NCT00225420

Run by

UNC Lineberger Comprehensive Cancer Center

People needed

23

Starts

2005-08-01

Expected to finish

2012-08-01

Last updated by the study team

2017-06-01

Who can join

Age: 18 and older, up to 120. Sex: male. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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

Where it is running

• Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill — Chapel Hill, North Carolina, United States
• Rex Cancer Center at Rex Hospital — Raleigh, North Carolina, United States

Full record on ClinicalTrials.gov

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