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A Randomized Phase II Trial of Doxil With or Without Dexamethasone in Treatment of Patients With Metastatic Hormone Refractory Prostate Cancer

Phase 2
18 Years
Not Enrolling
Prostate Cancer

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Trial Information

A Randomized Phase II Trial of Doxil With or Without Dexamethasone in Treatment of Patients With Metastatic Hormone Refractory Prostate Cancer

Primary Objectives:

To assess the anti-tumor activity of Doxil by assessing response rates in patients with
hormone refractory prostate cancer with or without dexamethasone pre-treatment.

Secondary Objectives:

To assess and estimate in patients with hormone refractory prostate cancer treated with
Doxil with or without pre-treatment dexamethasone: 1) overall survival 2) toxicity, 3)
quality of life parameters, 4) dose intensity administered in both treatment groups.

Study Design:

We will perform an open labeled, parallel, randomized phase II study using a two-stage
design to determine if there is sufficient anti-tumor activity in either arm to warrant
further study. Assumptions made in this study: an unacceptable overall response rate is 10% and we will pursue further study if the overall response rate is >/= 30%. The overall
response rate for this study will be based on the total number of responses observed defined
as: complete responses + partial responses (both by RECIST)+biochemical responses (in
patients with no measurable target lesions a >/= 50% decrease in PSA for >/= 4 weeks).
Fifteen patients will be randomized in the first phase (to both Arm 1 and Arm 2). No further
patients will be accrued if <2/15 responses are noted in a given arm. Ten additional
patients will be enrolled if >/= 2/15 responses are observed. If there are >/= 5/25
responses then further studies will be pursued with that regimen. We will determine the
overall incidence and severity of toxicities in both arms.


Arm 1: Doxil: Dose: 50 mg/m2, IV. Frequency: day 5 of each 28 day cycle. Arm 2: Doxil:
Dose: 50 mg/m2, IV. Frequency: day 5 of each 28 day cycle. Arm 1 only: Dexamethasone: Dose:
12 mg bid po. Frequency: days 1,2,3,4,5 of each 28 day cycle.

Number of Cycles for both Arm 1 and 2: until progression or unacceptable toxicity develops.

Inclusion Criteria:

1. Patients with metastatic hormone refractory prostate cancer as defined by resistance
to both ablative therapy (with either LHRH agonists or orchiectomy) & anti-androgens.

2. Patients must have symptoms related to disease.

3. Patients must have PS 0,1,2 (ECOG).

4. Patients must have measurable disease (RECIST) or PSA > 5.

5. Patients must have adequate organ function as defined as follows: leukocytes >/=
3,000/mm3, absolute neutrophil count >/= 1,500/mm3, hemoglobin >/= 8.0g/dl, platelets
>/= 100,000/mm3, serum creatinine ULN. Liver transaminases (SGOT and/or SGPT) may be up to 2.5 x institutional ULN if
alkaline phosphatase is transaminases are
6. Patients must have a left ventricular ejection fraction (LVEF) 50% by echocardiogram

7. Patients must have failed to respond to discontinuation of anti-androgens.

8. No previous therapy with anti-androgens, corticosteroids or estrogens in the last 4

9. Previous radiation therapy is allowed if completed at least 4 weeks prior to study
entry & therapy was cumulatively administered to
10. Patients must be >18 years of age

11. Patients must have an expected survival of at least 4 months.

12. Patients must have the ability to understand & the willingness to sign a written
informed consent document.

13. Patients must be willing to use adequate contraceptive method during treatment and
for 3 months after completing treatment.

Exclusion Criteria:

1. Patients with previous history of cancer are excluded unless they have had curative
treatment completed >/= 5 years prior to entry onto study or had 1 of the following:
in situ carcinoma (any location), basal cell carcinoma, or non-metastatic squamous
cell carcinoma of the skin.

2. Uncontrolled intercurrent illness including, but not limited to ongoing or active
infection, uncontrolled diabetes mellitus, or psychiatric illness/social situations
that would limit compliance with study requirements or the ability to provide
informed consent.

3. Patients requiring any non study corticosteroids for any reason are excluded.

4. Patients who have received previous chemotherapy.

5. A history of cardiac disease with New York Heart Class II or greater, or clinical
evidence of congestive heart failure.

6. Patients may not be receiving any other investigational agents or have participated
in any investigational drug study within 4 weeks preceding initiation of treatment.

7. Major surgery within 4 weeks prior to study treatment start, or lack of complete
recovery from major surgery.

8. Patients with a lack of physical integrity of the upper gastrointestinal tract or
those who have malabsorption syndrome or inability to swallow tablets.

9. History of hypersensitivity reactions attributed to a conventional formulation of
doxorubicin HCL or the components of Doxil®

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Percentage of subjects with CR or PR

Outcome Time Frame:

evaluated after 2 courses then every other course

Safety Issue:


Principal Investigator

John Rinehart, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

University of Kentucky


United States: Food and Drug Administration

Study ID:




Start Date:

October 2005

Completion Date:

February 2007

Related Keywords:

  • Prostate Cancer
  • prostate
  • prostate cancer
  • doxil
  • dexamethasone
  • metastatic
  • hormone refractory
  • Prostatic Neoplasms



University of Kentucky Lexington, Kentucky  40536-0098