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Estramustine and Paclitaxel in Treating Patients With Prostate Cancer That Has Not Responded to Hormone Therapy

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
New York University School of Medicine
ClinicalTrials.gov Identifier:
NCT00005048
First received: April 6, 2000
Last updated: November 8, 2012
Last verified: November 2000

April 6, 2000
November 8, 2012
April 1997
August 2000   (final data collection date for primary outcome measure)
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Complete list of historical versions of study NCT00005048 on ClinicalTrials.gov Archive Site
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Estramustine and Paclitaxel in Treating Patients With Prostate Cancer That Has Not Responded to Hormone Therapy
Safety and Efficacy of One Hour Weekly Taxol Infusion and Estramustine in Hormone Refractory Prostate Cancer

RATIONALE: 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.

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.

OBJECTIVES: I. Determine the maximum tolerated dose (MTD) of paclitaxel with estramustine in patients with hormone refractory prostate cancer. II. Evaluate the toxicity of this combination at the MTD of paclitaxel in this patient population. III. Determine any objective tumor response arising from this treatment in these patients.

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.

Interventional
Phase 1
Primary Purpose: Treatment
Prostate Cancer
  • Drug: estramustine phosphate sodium
  • Drug: paclitaxel
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
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August 2000   (final data collection date for primary outcome measure)

DISEASE CHARACTERISTICS: Histologically confirmed adenocarcinoma of the prostate with progressive systemic disease despite at least 1 endocrine manipulation including 1 of the following: Orchiectomy LHRH analogue with or without flutamide, megestrol, or diethylstilbestrol Flutamide must be discontinued for at least 2 weeks with PSA stabilized above normal or rising Measurable or evaluable disease No brain metastasis

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
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No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00005048
CDR0000067640, NYU-9715, NCI-G00-1716
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New York University School of Medicine
New York University School of Medicine
National Cancer Institute (NCI)
Study Chair: Abraham Chachoua, MD New York University School of Medicine
New York University School of Medicine
November 2000

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP