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Phase II Open-Label Study of Taxoprexin (DHA-Paclitaxel) Injection by 2-Hour Intravenous Infusion in Patients With Metastatic Hormone-Refractory Prostate Cancer

Phase 2
18 Years
Open (Enrolling)
Prostate Cancer

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Trial Information

Phase II Open-Label Study of Taxoprexin (DHA-Paclitaxel) Injection by 2-Hour Intravenous Infusion in Patients With Metastatic Hormone-Refractory Prostate Cancer


- Determine the objective tumor response rate or prostate-specific antigen response,
duration of response, and time to disease progression in patients with metastatic
hormone-refractory prostate cancer treated with DHA-paclitaxel.

- Determine the overall survival of patients treated with this drug.

- Determine the toxicity profile of this drug in these patients.

- Assess the quality of life of patients treated with this drug.

OUTLINE: This is a multicenter study.

Patients receive DHA-paclitaxel IV over 2 hours on day 1. Treatment repeats every 21 days in
the absence of disease progression or unacceptable toxicity.

Quality of life is assessed at baseline, every 2 courses, and off study.

Patients are followed every 3 months.

PROJECTED ACCRUAL: A total of 18-50 patients will be accrued for this study.

Inclusion Criteria


- Histologically or cytologically confirmed adenocarcinoma of the prostate

- Progressive metastatic disease on continuous hormonal therapy (e.g., orchiectomy
or luteinizing hormone-releasing hormone (LHRH) agonist)

- Progressive disease is defined by all of the following:

- Measurable disease or lesions on bone scan

- Increases in prostate-specific antigen (PSA) levels on at least 2
consecutive measurements

- Continued PSA elevation after cessation of prior antiandrogen therapy (4
weeks after flutamide and nilutamide and 8 weeks after bicalutamide)

- PSA level at least 5 ng/mL

- Serum testosterone level less than 50 ng/mL

- Patients who have not undergone prior surgical castration should continue
primary androgen suppression (LHRH agonist)

- No known or clinical evidence of CNS metastasis



- 18 and over

Performance status:

- ECOG 0-1

Life expectancy:

- Not specified


- Absolute neutrophil count at least 1,500/mm^3

- Platelet count at least 100,000/mm^3


- Bilirubin no greater than 1.5 times upper limit of normal (ULN)

- SGOT or SGPT no greater than 2.5 times ULN


- Creatinine no greater than 1.5 times ULN


- No uncontrolled ventricular arrhythmia

- No myocardial infarction within the past 3 months

- No superior vena cava syndrome


- No peripheral neuropathy greater than grade 1

- No uncontrolled major seizure disorder

- No spinal cord compression


- No psychiatric disorder that would preclude informed consent

- No unstable or serious concurrent medical condition

- No concurrent serious infection requiring parenteral therapy

- No other prior or concurrent malignancy except:

- Curatively treated nonmelanoma skin cancer OR

- Other cancer curatively treated with surgery alone that has not recurred for
more than 5 years

- Fertile patients must use effective contraception during and for at least 6 months
after study therapy


Biologic therapy:

- No concurrent immunotherapy


- No prior taxanes

- Prior mitoxantrone or prednisone for metastatic disease allowed

- At least 28 days since prior chemotherapy and recovered

- No other concurrent chemotherapy

Endocrine therapy:

- See Disease Characteristics

- No concurrent hormonal therapy


- No prior samarium SM 153 lexidronam pentasodium or strontium chloride Sr 89

- Prior external radiotherapy for metastatic disease allowed

- At least 28 days since prior large-field radiotherapy and recovered

- No concurrent radiotherapy, including whole-brain radiotherapy for documented CNS


- See Disease Characteristics

- At least 14 days since prior major surgery and recovered


- No other prior nonhormonal treatment for metastatic disease

- At least 28 days since prior herbal preparations (e.g., PC-SPES) and recovered

- No other concurrent anticancer medications

Type of Study:


Study Design:

Primary Purpose: Treatment

Principal Investigator

Michael A. Carducci, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Sidney Kimmel Comprehensive Cancer Center


United States: Federal Government

Study ID:




Start Date:

April 2001

Completion Date:

Related Keywords:

  • Prostate Cancer
  • adenocarcinoma of the prostate
  • stage IV prostate cancer
  • recurrent prostate cancer
  • Prostatic Neoplasms



Kimmel Cancer Center of Thomas Jefferson University - Philadelphia Philadelphia, Pennsylvania  19107
Veterans Affairs Medical Center - East Orange East Orange, New Jersey  07018-1095
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins Baltimore, Maryland  21231-2410
Louisiana State University Health Sciences Center - Shreveport Shreveport, Louisiana  71130-3932
Herbert Irving Comprehensive Cancer Center New York, New York  10032
Lucille Parker Markey Cancer Center, University of Kentucky Lexington, Kentucky  40536-0093
Alta Bates Comprehensive Cancer Center Berkeley, California  94704
Arizona Oncology Associates Tucson, Arizona  85712-2254