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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

Phase 1/Phase 2
18 Years
Not Enrolling
Prostate Cancer

Thank you

Trial Information

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



- 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.


- 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.

Inclusion Criteria


- 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
abdomen and pelvis


- 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


- 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

Type of Study:


Study Design:

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

Outcome Measure:

Progression-free survival

Outcome Description:

PSA progression timepoint is defined as the midpoint between the last non-rising PSA and the first rising PSA.

Outcome Time Frame:

when 3 consecutive rising PSA values have been noted

Safety Issue:


Principal Investigator

Young Whang, MD, PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

UNC Lineberger Comprehensive Cancer Center


United States: Federal Government

Study ID:

LCCC 0420



Start Date:

August 2005

Completion Date:

August 2012

Related Keywords:

  • Prostate Cancer
  • adenocarcinoma of the prostate
  • stage I prostate cancer
  • stage II prostate cancer
  • stage III prostate cancer
  • stage IV prostate cancer
  • Adenocarcinoma
  • Prostatic Neoplasms



Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill Chapel Hill, North Carolina  27599-7570
Rex Cancer Center at Rex Hospital Raleigh, North Carolina  27607