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.
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.
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
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There are 8 Locations for this study
Tucson Arizona, 85712, United States
Berkeley California, 94704, United States
Lexington Kentucky, 40536, United States
Shreveport Louisiana, 71130, United States
Baltimore Maryland, 21231, United States
East Orange New Jersey, 07019, United States
New York New York, 10032, United States
Philadelphia Pennsylvania, 19107, United States
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