Study of Abraxane Plus Hormonal Therapy as Initial Treatment of Unresectable or Metastatic Prostate Cancer
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|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.)
7.5 mg monthly or 22.5 mg quarterly, can begin within 3 months of initiating Abraxane for 2 years
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 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
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|