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Phase II Trial of Abraxane Plus Hormonal Therapy as Initial Treatment of Unresectable or Metastatic Adenocarcinoma of the Prostate

Phase 2
18 Years
Not Enrolling
Prostatic Neoplasms

Thank you

Trial Information

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

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.

Inclusion Criteria:

- Histologic proof of adenocarcinoma of the prostate.

- Patients must belong to one of four groups: 1) Local/Regional with prior definitive
therapy: Patients with local/regional recurrence following prostatectomy or radiation
therapy who still have a normal bone scan. 2) Local/Regional without prior definitive
therapy: Patients felt to be unresectable, or are felt not to be candidates for,
radiation therapy. 3) Low volume bone disease: Patients with 1 or 2 bone metastases.
4) High volume bone/visceral disease: Patients with ≥ 3 metastatic bone sites or
visceral metastases.

- Patients meeting these criteria are eligible even without any radiographically
demonstrable abnormality. All patients must have an elevated PSA prior to initial
hormone exposure defined as: 1) For patients with prior prostatectomy, the PSA must
be rising with an associated doubling time of ≤ 3 months. 2) For patients with prior
radiation therapy, the PSA must be ≥ 1.0 ng/mL with an associated doubling time of ≤
3 months. 3) For patients with the prostate in place, the PSA must be elevated with
biopsy proven disease and are not candidates for local therapy.

- Patients may be on an LHRH agonist (with or without an anti-androgen), or already
medically castrated, at the time of study entry, provided such therapy was started
within 3 months of study entry.

- No previous cytotoxic systemic therapy of any kind is allowed, including systemic
irradiation with strontium-89 and samarium. Previous definitive radiotherapy to one
metastatic site is acceptable. At least 8 weeks must have elapsed since radiation
therapy to the pelvis. Patients having limited irradiation of a single metastatic
site are eligible 4 weeks following the completion of radiation.

- Patients may have had previous exposure to androgen deprivation therapy if it was
given for ≤ 6 months to, "downstage" the primary, and provided such therapy completed
at least 12 months prior to entry into this study.

- Patients must be free of serious co-morbidity and have a life expectancy of ≥ 3

- Patients must have adequate physiologic reserves as evidenced by Zubrod Performance
Status (ZPS) of ≤ 2, adequate bone marrow function, renal function and liver function
and no evidence of active ischemia on ECG (if clinically indicated, documentation of
EF ≥ 40%.)

Exclusion Criteria:

- Patients must not have a second malignancy unless there is confidence of previous
curative therapy.

- Patients with a recent history of TIA (within 6 months), or are requiring regular
antianginal therapy or are having claudication sufficient to limit activity are not
eligible. Patients with a previous history of deep venous thrombosis or pulmonary
embolism (within 12 months) are not eligible.

- Patients must not have a serious intercurrent medical or psychiatric illness,
including serious active infection.

- Patients must not have Sensory neuropathy of grade 1 or greater.

Type of Study:


Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

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.

Outcome Time Frame:

measurements every 4 wks while on Abraxane; then every 12 wks

Safety Issue:


Principal Investigator

Robert J Amato, DO

Investigator Role:

Principal Investigator

Investigator Affiliation:

The Methodist Hospital Research Institute


United States: Institutional Review Board

Study ID:




Start Date:

August 2007

Completion Date:

October 2008

Related Keywords:

  • Prostatic Neoplasms
  • Unresectable or Metastatic Adenocarcinoma Prostate Cancer
  • Hormonal Therapy
  • Abraxane
  • M3thodist
  • Adenocarcinoma
  • Neoplasms
  • Prostatic Neoplasms



The Methodist Hospital System Houston, Texas  77030