Estramustine and Paclitaxel in Treating Patients With Prostate Cancer That Has Not Responded to Hormone Therapy
NCT ID: NCT00005048
Last Updated: 2012-11-09
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
INTERVENTIONAL
1997-04-30
Brief Summary
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PURPOSE: Phase I trial to study the effectiveness of combining estramustine and paclitaxel in treating patients who have prostate cancer that has not responded to hormone therapy.
Detailed Description
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OUTLINE: This is a dose escalation study of paclitaxel. Patients receive oral estramustine daily on days 1-3 and paclitaxel IV over 1 hour on day 3 weekly for 6 weeks followed by 1 week of rest. Treatment continues for at least 2 courses in the absence of unacceptable toxicity or disease progression. Cohorts of 3-6 patients receive escalating doses of paclitaxel until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 6 patients experience dose limiting toxicities.
PROJECTED ACCRUAL: A minimum of 18 patients will be accrued for this study within 18 months.
Conditions
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Keywords
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Study Design
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TREATMENT
Interventions
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estramustine phosphate sodium
paclitaxel
Eligibility Criteria
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Inclusion Criteria
PATIENT CHARACTERISTICS: Age: Not specified Performance status: ECOG 0-2 Life expectancy: Greater than 2 months Hematopoietic: Granulocyte count at least 1,500/mm3 Platelet count at least 100,000/mm3 Hepatic: Bilirubin greater than 1 mg/dL SGOT greater than 2 times upper limit of normal Renal: Creatinine less than 2 mg/dL Hydronephrosis with impaired renal function must be decompressed adequately Cardiovascular: No severe cardiac (i.e., symptomatic arrhythmia requiring medication or active congestive heart failure) or coronary disease that are unstable despite medication Other: Adequate nutritional status (at least 1,500 Kcal/day) No other significant active medical illness that would preclude study therapy or survival No other malignancy within the past 5 years except adequately treated basal or squamous cell carcinoma of the skin No acute spinal cord compression
PRIOR CONCURRENT THERAPY: Biologic therapy: No concurrent biologic response modifiers Chemotherapy: No other concurrent chemotherapy Endocrine therapy: See Disease Characteristics At least 2 weeks since prior corticosteroids No concurrent exogenous corticosteroids except for documented CNS metastases or adrenal insufficiency Concurrent hormones for nondisease conditions allowed (e.g., insulin for diabetes mellitus) Concurrent continuation of monthly hormonal therapy with an LHRH agonist or DES required Radiotherapy: Prior radiation to symptomatic metastatic site allowed provided it is not the only measurable or evaluable lesion At least 2 weeks since prior radiotherapy and recovered No concurrent radiotherapy No concurrent palliative radiotherapy except for whole brain irradiation for documented CNS disease or impending spinal cord compression Surgery: See Disease Characteristics At least 3 weeks since prior surgery and recovered Other: No other concurrent treatment for prostate cancer except pain palliation
MALE
No
Sponsors
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National Cancer Institute (NCI)
NIH
NYU Langone Health
OTHER
Responsible Party
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Principal Investigators
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Abraham Chachoua, MD
Role: STUDY_CHAIR
NYU Langone Health
Locations
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Kaplan Cancer Center
New York, New York, United States
Mount Sinai Medical Center, NY
New York, New York, United States
Countries
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Other Identifiers
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NYU-9715
Identifier Type: -
Identifier Source: secondary_id
NCI-G00-1716
Identifier Type: -
Identifier Source: secondary_id
CDR0000067640
Identifier Type: -
Identifier Source: org_study_id