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A Phase II Study of AT101, to Abrogate BCL-2 Mediated Resistance to Androgen Ablation Therapy in Patients With Newly Diagnosed Stage D2 Prostate Cancer


Phase 2
18 Years
N/A
Not Enrolling
Male
Adenocarcinoma of the Prostate, Stage IV Prostate Cancer

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Trial Information

A Phase II Study of AT101, to Abrogate BCL-2 Mediated Resistance to Androgen Ablation Therapy in Patients With Newly Diagnosed Stage D2 Prostate Cancer


PRIMARY OBJECTIVE:

I. To determine the percentage of patients with newly diagnosed metastatic prostate cancer
who demonstrate undetectable prostate-specific antigen (PSA) (< 0.2 ng/mL) at 7 months when
treated with R-(-)-gossypol (AT-101) and androgen ablation therapy.

SECONDARY OBJECTIVES:

I. To determine the safety of this regimen in these patients. II. To determine the
percentage of patients with PSA >= 4.0 ng/mL, overall PSA < 4.0 ng/mL, and a PSA >= 0.2
ng/mL but < 4.0 ng/mL during the first 7 months of therapy.

III. To determine changes in Bcl-2 and Bax/Bak protein expression in peripheral blood
mononuclear cells after treatment.

IV. To analyze Bcl-2 family protein expression in baseline tumor tissue.

OUTLINE:

Patients receive R-(-)-gossypol orally (PO) once daily (QD) on days 1-21. Treatment repeats
every 28 weeks for 8 courses in the absence of disease progression or unacceptable toxicity.
Patients may receive bicalutamide PO QD beginning 6 weeks before the initiation of
R-(-)-gossypol and continuing after completion of treatment, at the discretion of the
treating physician.

Inclusion Criteria


Criteria:

- Newly diagnosed disease

- Baseline prostate-specific antigen (PSA) >= 5.0 ng/mL (within 12 weeks prior to
registration)

- No acute spinal cord compression

- No known brain metastases

- ECOG performance status (PS) 0-2 OR Karnofsky PS 60-100%

- Life expectancy > 6 months

- Total bilirubin normal

- AST and/or ALT =< 2.5 times upper limit of normal

- Creatinine normal OR creatinine clearance >= 60 mL/min

- Fertile patients must use effective contraception

- No history of allergic reactions attributed to compounds of similar chemical or
biologic composition to AT-101 or other agents used in the study

- No history of bowel obstruction or gastrointestinal (GI) motility disorder

- No concurrent uncontrolled illness

- No unstable angina pectoris

- No ongoing or active infection

- No symptomatic congestive heart failure

- No cardiac arrhythmia

- No psychiatric illness or social situation that would limit compliance with study
requirements

- No condition (e.g., GI tract disease resulting in an inability to take oral
medication or a requirement for IV alimentation or active peptic ulcer disease) that
impairs the ability to swallow and retain AT-101 tablets

- Leukocytes >= 3,000/mcL Absolute neutrophil count >= 1,500/mcL (without transfusion)

- At least 12 months since prior androgen ablation therapy or antiandrogen therapy in
the adjuvant or neoadjuvant setting

- No prior androgen ablation therapy for metastatic disease (beyond the 6-week
induction period prior to initiation of R-(-)-gossypol [AT-101])

- More than 4 weeks since prior radiotherapy and recovered

- No concurrent chemotherapy or radiotherapy

- No other concurrent investigational agents

- No concurrent routine use of hematopoietic growth factors (including filgrastim
[G-CSF], sargramostim [GM-CSF], or interleukin-11) during the first course of study
treatment

- No concurrent combination antiretroviral therapy for HIV-positive patients

- Platelet count >= 100,000/mcL (without transfusion)

- Histologically confirmed adenocarcinoma of the prostate

- Clinical stage D2 disease, defined by soft tissue or bony metastasis

- No prior surgical procedures affecting absorption

- No prior bilateral orchiectomy

- Other prior local surgery allowed

Type of Study:

Interventional

Study Design:

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Percentage of patients with undetectable prostate-specific antigen (PSA) (< 0.2 ng/mL)

Outcome Time Frame:

At 7 months

Safety Issue:

No

Principal Investigator

Robert DiPaola

Investigator Role:

Principal Investigator

Investigator Affiliation:

Cancer Institute of New Jersey

Authority:

United States: Food and Drug Administration

Study ID:

NCI-2009-00264

NCT ID:

NCT00666666

Start Date:

July 2009

Completion Date:

Related Keywords:

  • Adenocarcinoma of the Prostate
  • Stage IV Prostate Cancer
  • Adenocarcinoma
  • Adenocarcinoma, Mucinous
  • Prostatic Neoplasms

Name

Location

Cancer Institute of New JerseyNew Brunswick, New Jersey  08901
University of Wisconsin Hospital and ClinicsMadison, Wisconsin  53792-0001