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
18 Years
N/A
Male
Prostate Cancer
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
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.
Inclusion Criteria
DISEASE CHARACTERISTICS:
- 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
PATIENT CHARACTERISTICS:
- 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
year
- 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
Type of Study:
Interventional
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:
No
Principal Investigator
Young Whang, MD, PhD
Investigator Role:
Principal Investigator
Investigator Affiliation:
UNC Lineberger Comprehensive Cancer Center
Authority:
United States: Federal Government
Study ID:
LCCC 0420
NCT ID:
NCT00225420
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
Name | Location |
|---|---|
| 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 |
