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Paclitaxel, Topotecan, and Estramustine in Treating Patients With Metastatic Hormone-Refractory Prostate Cancer

Primary Purpose

Prostate Cancer

Status
Withdrawn
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
estramustine phosphate sodium
paclitaxel
topotecan hydrochloride
Sponsored by
Fox Chase Cancer Center
About
Eligibility
Locations
Outcomes
Full info

About this trial

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

Eligibility Criteria

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

DISEASE CHARACTERISTICS: Histologically confirmed adenocarcinoma of the prostate gland Progressive metastatic disease (e.g., bone, pelvic mass, lymph node, liver or lung metastases) Radiologic evidence of hydronephrosis alone dose not constitute metastatic disease Failed prior primary hormonal therapy (e.g., estrogen therapy, luteinizing hormone-releasing hormone blocker and flutamide) or bilateral orchiectomy Patients previously treated with flutamide or bicalutamide must have evidence of disease progression i.e., increasing Prostate-Specific Antigen (PSA) PSA level ≥ 10 ng/mL if bone metastases only are present (i.e., lacking measurable soft tissue disease) No elevated serum acid phosphatase or PSA level as the only evidence of disease No carcinomatous meningitis or brain metastases PATIENT CHARACTERISTICS: Age 18 and over Performance status Eastern Cooperative Oncology Group (ECOG) 0-2 Life expectancy At least 12 weeks Hematopoietic White Blood Cell (WBC) ≥ 4,000/mm^3 OR Granulocyte count ≥ 2,000/mm^3 Platelet count ≥ 100,000/mm^3 Hepatic Serum Glutamic-Oxaloacetic Transaminase(SGOT) and Serum Glutamic-Pyruvic Transaminase (SGPT) ≤ 2 times normal Bilirubin ≤ 1.5 mg/dL Renal Creatinine ≤ 2.0 mg/dL OR Creatinine clearance ≥ 50 mL/min Cardiovascular History of deep venous thrombosis allowed provided patients are maintained on therapeutic anticoagulation therapy No active angina pectoris No New York Heart Association class II-IV heart disease No myocardial infarction within the past 6 months No thrombosis within the past 3 months Other Fertile patients must use effective contraception during and for 3 months after study participation No active infection No other concurrent serious medical illness that would preclude study participation No other malignancy within the past 3 years except curatively treated basal cell or squamous cell skin cancer PRIOR CONCURRENT THERAPY: Biologic therapy Not specified Chemotherapy No prior chemotherapy Endocrine therapy See Disease Characteristics At least 4 weeks since prior flutamide At least 8 weeks since prior bicalutamide Radiotherapy More than 4 weeks since prior radiotherapy No prior strontium chloride Sr 89 or samarium Sm 153 lexidronam pentasodium Surgery See Disease Characteristics Other Recovered from all prior therapy No prior cytotoxic therapy for prostate cancer No concurrent milk, milk products, antacids, calcium-containing drugs, or food during estramustine administration

Sites / Locations

    Outcomes

    Primary Outcome Measures

    Secondary Outcome Measures

    Full Information

    First Posted
    June 10, 2004
    Last Updated
    July 9, 2013
    Sponsor
    Fox Chase Cancer Center
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00084565
    Brief Title
    Paclitaxel, Topotecan, and Estramustine in Treating Patients With Metastatic Hormone-Refractory Prostate Cancer
    Official Title
    Phase II Study of the Activity of Weekly Paclitaxel, Topotecan Plus Oral Estramustine Phosphate in Metastatic Hormone-Refractory Prostate Carcinoma
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    July 2013
    Overall Recruitment Status
    Withdrawn
    Why Stopped
    Study was never activated at Fox Chase Cancer Center.
    Study Start Date
    November 2003 (undefined)
    Primary Completion Date
    November 2004 (Actual)
    Study Completion Date
    November 2004 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Fox Chase Cancer Center

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    RATIONALE: Drugs used in chemotherapy, such as paclitaxel, topotecan, and estramustine, work in different ways to stop tumor cells from dividing so they stop growing or die. Giving more than one chemotherapy drug may kill more tumor cells. PURPOSE: This phase II trial is studying how well giving paclitaxel, topotecan, and estramustine together works in treating patients with metastatic hormone therapy-refractory prostate cancer.
    Detailed Description
    OBJECTIVES: Primary Determine the objective response rate in patients with metastatic hormone-refractory prostate cancer treated with paclitaxel, topotecan, and estramustine. Determine the progression-free and overall survival of patients treated with this regimen. Determine the toxic effects of this regimen in these patients. Determine the pharmacokinetics of this regimen in these patients. Secondary Determine the frequency and number of circulating tumor cells in patients before and after treatment with this regimen and at disease progression. Determine the microtubule morphology, β-tubulin isotype pattern, apoptotic markers, and metaphase chromosome alignment in circulating tumor cells in patients before and after treatment with this regimen and at disease progression. OUTLINE: Patients receive paclitaxel IV over 1 hour on days 1, 8, and 15; topotecan IV over 30 minutes on days 2, 9, and 16; and oral estramustine twice daily on days 1 and 2 of course 1 and on days 0-2, 7-9, and 14-16 of all subsequent courses. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. PROJECTED ACCRUAL: A total of 18-38 patients will be accrued for this study.

    6. Conditions and Keywords

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

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 2
    Masking
    None (Open Label)
    Enrollment
    0 (Actual)

    8. Arms, Groups, and Interventions

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

    10. Eligibility

    Sex
    Male
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    DISEASE CHARACTERISTICS: Histologically confirmed adenocarcinoma of the prostate gland Progressive metastatic disease (e.g., bone, pelvic mass, lymph node, liver or lung metastases) Radiologic evidence of hydronephrosis alone dose not constitute metastatic disease Failed prior primary hormonal therapy (e.g., estrogen therapy, luteinizing hormone-releasing hormone blocker and flutamide) or bilateral orchiectomy Patients previously treated with flutamide or bicalutamide must have evidence of disease progression i.e., increasing Prostate-Specific Antigen (PSA) PSA level ≥ 10 ng/mL if bone metastases only are present (i.e., lacking measurable soft tissue disease) No elevated serum acid phosphatase or PSA level as the only evidence of disease No carcinomatous meningitis or brain metastases PATIENT CHARACTERISTICS: Age 18 and over Performance status Eastern Cooperative Oncology Group (ECOG) 0-2 Life expectancy At least 12 weeks Hematopoietic White Blood Cell (WBC) ≥ 4,000/mm^3 OR Granulocyte count ≥ 2,000/mm^3 Platelet count ≥ 100,000/mm^3 Hepatic Serum Glutamic-Oxaloacetic Transaminase(SGOT) and Serum Glutamic-Pyruvic Transaminase (SGPT) ≤ 2 times normal Bilirubin ≤ 1.5 mg/dL Renal Creatinine ≤ 2.0 mg/dL OR Creatinine clearance ≥ 50 mL/min Cardiovascular History of deep venous thrombosis allowed provided patients are maintained on therapeutic anticoagulation therapy No active angina pectoris No New York Heart Association class II-IV heart disease No myocardial infarction within the past 6 months No thrombosis within the past 3 months Other Fertile patients must use effective contraception during and for 3 months after study participation No active infection No other concurrent serious medical illness that would preclude study participation No other malignancy within the past 3 years except curatively treated basal cell or squamous cell skin cancer PRIOR CONCURRENT THERAPY: Biologic therapy Not specified Chemotherapy No prior chemotherapy Endocrine therapy See Disease Characteristics At least 4 weeks since prior flutamide At least 8 weeks since prior bicalutamide Radiotherapy More than 4 weeks since prior radiotherapy No prior strontium chloride Sr 89 or samarium Sm 153 lexidronam pentasodium Surgery See Disease Characteristics Other Recovered from all prior therapy No prior cytotoxic therapy for prostate cancer No concurrent milk, milk products, antacids, calcium-containing drugs, or food during estramustine administration
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Gary R. Hudes, MD
    Organizational Affiliation
    Fox Chase Cancer Center
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Learn more about this trial

    Paclitaxel, Topotecan, and Estramustine in Treating Patients With Metastatic Hormone-Refractory Prostate Cancer

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