Phase II Trial of Abraxane Plus Hormonal Therapy as Initial Treatment of Unresectable or Metastatic Adenocarcinoma of the Prostate
Abraxane is a potent anticancer drug that stops cancer cells from growing and dividing by
interfering with certain cell structures and killing the cancer cells. Abraxane is the first
albumin-bound taxane particle of approximately 130 nanometers that takes advantage of
albumin, a natural carrier of water-insoluble molecules (e.g., various nutrients, vitamins,
and hormones) found in humans. Albumin is a protein that acts as the body's key transporter
of nutrients and other water-insoluble molecules and selectively accumulates in tumor
tissues.
The delivery of chemotherapy/hormone therapy in a setting of androgen-independent prostate
cancer has demonstrated: survival benefit associated with a PSA decline and tolerable
toxicity, thus strongly suggesting that disease modifying potential exists. Preclinical
data supports the benefit of simultaneous chemotherapy/hormonal therapy and androgen
deprivation. The stage is set for chemotherapy/hormonal therapy to be given earlier in men
with prostate cancer. Data suggests a transformation from an androgen-dependent to an
androgen-independent phenotype is mediated by the expansion of an androgen-independent clone
already present at the time of androgen deprivation. If this model is correct, it would be
feasible to bring chemotherapy/hormonal therapy up front when the corresponding tumor burden
is minimal.
It is hoped that by bringing therapy against all components of the tumor initially, the
emergence of androgen-independent growth will be delayed, ultimately prolonging patient
survival. This study will test this hypothesis of Abraxane plus hormonal therapy followed by
standard hormonal therapy.
Interventional
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Assess the clinical benefit as measured by time to tumor progression of Abraxane plus hormonal therapy when applied to previously untreated patients with unresectable or metastatic adenocarcinoma of the prostate.
measurements every 4 wks while on Abraxane; then every 12 wks
No
Robert J Amato, DO
Principal Investigator
The Methodist Hospital Research Institute
United States: Institutional Review Board
PCa-07-102
NCT00521781
August 2007
October 2008
Name | Location |
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The Methodist Hospital System | Houston, Texas 77030 |