Paclitaxel and Bryostatin 1 in Treating Patients With Metastatic Prostate Cancer

Study Overview
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Brief Summary
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Phase II trial to study the effectiveness of combining paclitaxel and bryostatin 1 in treating patients who have metastatic prostate cancer that has not responded to hormone therapy. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells.

Detailed Description
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OBJECTIVES: I. Determine the onset, duration, and degree of response in patients with hormone-refractory, metastatic adenocarcinoma of the prostate treated with paclitaxel and bryostatin 1. II. Determine the toxicity of this regimen in these patients. III. Determine the overall survival of patients treated with this regimen. OUTLINE: This is an open-label, multicenter study. Patients receive paclitaxel IV over 1 hour on days 1, 8, and 15 and bryostatin 1 IV over 1 hour on days 2, 9, and 16. Treatment repeats every 4 weeks in the absence of disease progression or unacceptable toxicity. Patients are followed monthly for 6 months and then every 3 months thereafter.

Official Title
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Phase II Study of Weekly Paclitaxel and Bryostatin-1 in Hormone Refractory Prostate Cancer

Conditions
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Prostate Cancer

Intervention / Treatment
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* Drug: bryostatin 1
* Drug: paclitaxel


Participation Criteria
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Eligibility Criteria
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DISEASE CHARACTERISTICS: Histologically confirmed metastatic adenocarcinoma of the prostate that failed first- or second-line hormonal therapy (e.g., gonadal androgen suppression [orchiectomy or luteinizing hormone-releasing hormone] with or without antiandrogens) Failure on hormonal therapy is defined by 1 of the following criteria: Biochemical progression (after withdrawal of antiandrogens), documented by 3 rising PSA values, each value measured at least 2 weeks apart, with the last measurement being at least 25% of the nadir achieved while on hormonal therapy and with an increase in the absolute value by at least 5 ng/mL Measurable disease progression, defined by an increase in the sum of the products of the perpendicular diameters of any measurable lesion(s) by at least 25% Bone only progression allowed only with concurrent biochemical progression Castrate levels of testosterone (no greater than 50 ng/dL) No clinical signs/symptoms suggesting CNS metastases PATIENT CHARACTERISTICS: Age 18 and over Performance status ECOG 0-1 Life expectancy More than 6 months Hematopoietic WBC at least 3,000/mm^3 Absolute granulocyte 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) AST/ALT no greater than 2.5 times ULN Renal Creatinine no greater than 1.5 times ULN Calcium no greater than ULN Cardiovascular No uncontrolled or severe cardiovascular disease No myocardial infarction within the past 6 months No congestive heart failure No angina pectoris No active thromboembolic events within the past 3 months (e.g., deep venous thrombosis or cerebrovascular accident) Other No other serious medical or psychiatric illness No active infection No dementia or significantly altered mental status No prior or concurrent grade 1 or greater peripheral neuropathy No other prior or concurrent malignancy within the past 5 years except curatively treated nonmelanoma skin cancer HIV negative Fertile patients must use effective contraception PRIOR CONCURRENT THERAPY: Chemotherapy No prior chemotherapy (including paclitaxel) Endocrine therapy At least 4 weeks since prior steroids or megestrol Radiotherapy At least 4 weeks since prior radiotherapy to bone lesions Other No other concurrent investigational therapy

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Arm I<br>Patients receive paclitaxel IV over 1 hour on days 1, 8, and 15 and bryostatin 1 IV over 1 hour on days 2, 9, and 16. Treatment repeats every 4 weeks in the absence of disease progression or unacceptable toxicity. | Drug: bryostatin 1<br> <br> Drug: paclitaxel<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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adenocarcinoma of the prostate, stage IV prostate cancer, recurrent prostate cancer