Study of Abraxane Plus Hormonal Therapy as Initial Treatment of Unresectable or Metastatic Prostate Cancer
The purpose of the clinical trial is to 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, as well as to assess safety and tolerability of the study drug regimen and to evaluate secondary efficacy endpoints such as overall survival and duration of response.
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Phase II Trial of Abraxane Plus Hormonal Therapy as Initial Treatment of Unresectable or Metastatic Adenocarcinoma of the Prostate|
- 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. [ Time Frame: measurements every 4 wks while on Abraxane; then every 12 wks ] [ Designated as safety issue: No ]
- Assess safety and tolerability of the study drug regimen. Overall survival Duration of response PSA "lead-time" to symptomatic or radiographic progression. [ Time Frame: AEs as occur ] [ Designated as safety issue: Yes ]
|Study Start Date:||August 2007|
|Study Completion Date:||October 2008|
|Primary Completion Date:||September 2008 (Final data collection date for primary outcome measure)|
Treatment will be Abraxane/hormonal therapy (LHRH Agonist) for four nine-week cycles, followed by Total androgen blockade therapy (LHRH Agonist+ Anti-androgen) for 2 years from the time the hormonal therapy was started.
100 mg/m2 IVPB Day 1, 8, 15, 22, 29,36,43,50 of each cycle for 4 nine-week cycles (Each cycle of Abraxane/hormonal therapy will consist of 8 weeks of Abraxane therapy and 1 week of rest.)Drug: Leuprolide
7.5 mg monthly or 22.5 mg quarterly, can begin within 3 months of initiating Abraxane for 2 years
Other Names:Drug: Bicalutamide
50 mg p.o. daily starts week 36 of initiating Abraxane.
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.
|United States, Texas|
|The Methodist Hospital System|
|Houston, Texas, United States, 77030|
|Principal Investigator:||Robert J Amato, DO||The Methodist Hospital Research Institute|