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

Information source: UNC Lineberger Comprehensive Cancer Center
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Prostate Cancer

Intervention: docetaxel (Drug); leuprolide acetate (Drug); radiation therapy (Radiation)

Phase: Phase 1/Phase 2

Status: Completed

Sponsored by: UNC Lineberger Comprehensive Cancer Center

Official(s) and/or principal investigator(s):
Young Whang, MD, PhD, Principal Investigator, Affiliation: UNC Lineberger Comprehensive Cancer Center


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.

Clinical Details

Official title: A Phase I/II Study of Concurrent Weekly Docetaxel (Taxotere), Androgen Ablation, and Adaptive External Beam Radiotherapy for Localized High-Risk Adenocarcinoma of the Prostate

Study design: Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome:

Progression-free survival


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 radiotherapy in patients with high-risk localized adenocarcinoma of the prostate. Secondary

- Determine the 2-year biochemical progression-free survival of patients treated with

this regimen. OUTLINE: This is a multicenter, open-label, dose-escalation study of docetaxel.

- Androgen ablation therapy: Patients receive leuprolide acetate or other luteinizing

hormone-releasing hormone agonist beginning 2-3 months prior to the start of chemoradiotherapy and continuing for up to 2 years.

- Chemoradiotherapy: Patients receive docetaxel IV over 1 hour on day 1 and high-dose

external-beam radiotherapy on days 1-5. Treatment repeats every 7 days for 8 courses in the absence of disease progression or unacceptable toxicity. Cohorts of 3-6 patients receive escalating doses of docetaxel until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity. After completion of study treatment, patients are followed every 3 months.


Minimum age: 18 Years. Maximum age: N/A. Gender(s): Male.



- Histologically confirmed adenocarcinoma of the prostate

- High-risk localized disease, meeting 1 of the following criteria:

- T3 or T4

- T1-2 with Gleason score 8-10

- T1-2 with Gleason score 7 AND PSA ≥ 10 ng/mL

- T1-2 with any Gleason score AND PSA ≥ 20 ng/mL

- No evidence of metastatic disease on chest x-ray, bone scan, or CT scan of the


- ECOG performance status 0-1

- Life expectancy ≥ 10 years

- Absolute neutrophil count ≥ 1,500/mm^3

- Hemoglobin ≥ 8. 0 g/dL

- Platelet count ≥ 100,000/mm^3

- Bilirubin ≤ 1. 2 mg/dL

- Creatinine ≤ 1. 5 times upper limit of normal (ULN)

- AST and ALT ≤ 1. 5 times ULN

- Alkaline phosphatase ≤ 2. 5 times ULN

- Fertile patients must use effective contraception during and for ≥ 3 months after

completion of study therapy

- No peripheral neuropathy > grade 1

- No myocardial infarction or significant change in anginal pattern within the past


- No New York Heart Association class II-IV congestive heart failure

- No history of severe hypersensitivity reaction to docetaxel or other drugs formulated

with polysorbate 80

- No other invasive malignancy within the past 5 years except for carcinoma in situ or

nonmelanoma skin cancer

- No concurrent uncontrolled illness, psychiatric condition, or other condition that

would preclude study treatment PRIOR CONCURRENT THERAPY:

- No prior pelvic or prostate radiotherapy for prostate cancer

- No prior chemotherapy for prostate cancer

- Prior androgen ablation therapy with luteinizing hormone-releasing hormone agonists

allowed provided study treatment is started within 3 months of the initiation of androgen ablation therapy

- No other concurrent investigational agents

- Concurrent anticoagulation with stable dose of warfarin or low molecular weight

heparin allowed

Locations and Contacts

Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill, Chapel Hill, North Carolina 27599-7295, United States

Rex Cancer Center at Rex Hospital, Raleigh, North Carolina 27607, United States

Additional Information

Starting date: August 2005
Last updated: September 18, 2012

Page last updated: August 23, 2015

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