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

Primary Purpose

Prostate Cancer

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
estramustine phosphate sodium
paclitaxel
Sponsored by
NYU Langone Health
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Prostate Cancer focused on measuring adenocarcinoma of the prostate, recurrent prostate cancer

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)MaleDoes not accept healthy volunteers

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

Sites / Locations

  • Kaplan Cancer Center
  • Mount Sinai Medical Center, NY

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
April 6, 2000
Last Updated
November 8, 2012
Sponsor
NYU Langone Health
Collaborators
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT00005048
Brief Title
Estramustine and Paclitaxel in Treating Patients With Prostate Cancer That Has Not Responded to Hormone Therapy
Official Title
Safety and Efficacy of One Hour Weekly Taxol Infusion and Estramustine in Hormone Refractory Prostate Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
November 2000
Overall Recruitment Status
Completed
Study Start Date
April 1997 (undefined)
Primary Completion Date
August 2000 (Actual)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
NYU Langone Health
Collaborators
National Cancer Institute (NCI)

4. Oversight

5. Study Description

Brief Summary
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.
Detailed Description
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prostate Cancer
Keywords
adenocarcinoma of the prostate, recurrent prostate cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
estramustine phosphate sodium
Intervention Type
Drug
Intervention Name(s)
paclitaxel

10. Eligibility

Sex
Male
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Abraham Chachoua, MD
Organizational Affiliation
NYU Langone Health
Official's Role
Study Chair
Facility Information:
Facility Name
Kaplan Cancer Center
City
New York
State/Province
New York
ZIP/Postal Code
10016
Country
United States
Facility Name
Mount Sinai Medical Center, NY
City
New York
State/Province
New York
ZIP/Postal Code
10029
Country
United States

12. IPD Sharing Statement

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

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