Prostate Cancer Clinical Trial

DHA-Paclitaxel in Treating Patients With Metastatic Prostate Cancer

Summary

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die.

PURPOSE: Phase II trial to study the effectiveness of DHA-paclitaxel in treating patients who have metastatic prostate cancer that has not responded to hormone therapy.

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Full Description

OBJECTIVES:

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.

View Eligibility Criteria

Eligibility Criteria

DISEASE CHARACTERISTICS:

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

PATIENT CHARACTERISTICS:

Age:

18 and over

Performance status:

ECOG 0-1

Life expectancy:

Not specified

Hematopoietic:

Absolute neutrophil count at least 1,500/mm^3
Platelet count at least 100,000/mm^3

Hepatic:

Bilirubin no greater than 1.5 times upper limit of normal (ULN)
SGOT or SGPT no greater than 2.5 times ULN

Renal:

Creatinine no greater than 1.5 times ULN

Cardiovascular:

No uncontrolled ventricular arrhythmia
No myocardial infarction within the past 3 months
No superior vena cava syndrome

Neurologic:

No peripheral neuropathy greater than grade 1
No uncontrolled major seizure disorder
No spinal cord compression

Other:

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

PRIOR CONCURRENT THERAPY:

Biologic therapy:

No concurrent immunotherapy

Chemotherapy:

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

Radiotherapy:

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 metastasis

Surgery:

See Disease Characteristics
At least 14 days since prior major surgery and recovered

Other:

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

Study is for people with:

Prostate Cancer

Phase:

Phase 2

Study ID:

NCT00024414

Recruitment Status:

Unknown status

Sponsor:

Theradex

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There are 8 Locations for this study

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Arizona Oncology Associates
Tucson Arizona, 85712, United States
Alta Bates Comprehensive Cancer Center
Berkeley California, 94704, United States
Lucille Parker Markey Cancer Center, University of Kentucky
Lexington Kentucky, 40536, United States
Louisiana State University Health Sciences Center - Shreveport
Shreveport Louisiana, 71130, United States
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Baltimore Maryland, 21231, United States
Veterans Affairs Medical Center - East Orange
East Orange New Jersey, 07019, United States
Herbert Irving Comprehensive Cancer Center
New York New York, 10032, United States
Kimmel Cancer Center of Thomas Jefferson University - Philadelphia
Philadelphia Pennsylvania, 19107, United States

How clear is this clinincal trial information?

Study is for people with:

Prostate Cancer

Phase:

Phase 2

Study ID:

NCT00024414

Recruitment Status:

Unknown status

Sponsor:


Theradex

How clear is this clinincal trial information?

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