Study of Abraxane Plus Hormonal Therapy as Initial Treatment of Unresectable or Metastatic Prostate Cancer
|ClinicalTrials.gov Identifier: NCT00521781|
Recruitment Status : Terminated (Sponsor decision)
First Posted : August 28, 2007
Last Update Posted : March 17, 2016
|Condition or disease||Intervention/treatment||Phase|
|Prostatic Neoplasms||Drug: Abraxane Drug: Leuprolide Drug: Bicalutamide||Phase 2|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||14 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Phase II Trial of Abraxane Plus Hormonal Therapy as Initial Treatment of Unresectable or Metastatic Adenocarcinoma of the Prostate|
|Study Start Date :||August 2007|
|Actual Primary Completion Date :||September 2008|
|Actual Study Completion Date :||October 2008|
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.
- 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 ]
- 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 ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00521781
|United States, Texas|
|Baylor College of Medicine - Methodist Hospital|
|Houston, Texas, United States, 77030|
|Principal Investigator:||Robert J Amato, DO||Baylor College of Medicine - Methodist Hospital|