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Combination Chemotherapy in Treating Patients With Prostate Cancer That Has Not Responded to Hormone Therapy

Primary Purpose

Pain, Prostate Cancer

Status
Unknown status
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
filgrastim
cyclophosphamide
docetaxel
doxorubicin hydrochloride
pain therapy
Sponsored by
Amgen
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pain focused on measuring adenocarcinoma of the prostate, stage I prostate cancer, stage IIB prostate cancer, stage IIA prostate cancer, stage III prostate cancer, stage IV prostate cancer, recurrent prostate cancer, pain

Eligibility Criteria

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

DISEASE CHARACTERISTICS: Histologically proven adenocarcinoma of the prostate that is chemotherapy naive and refractory to hormonal therapy with combined androgen blockade No concurrent antiandrogen therapy withdrawal: Must continue antiandrogen therapy until completion of study OR Must discontinue flutamide at least 4 weeks before or bicalutamide at least 8 weeks before study enrollment, and must have disease progression off antiandrogen therapy, defined by serial increase in PSA (at least 2 measurements taken at least 2 weeks apart) or measurable tumor Concurrent LHRH antagonist allowed if no prior orchiectomy No minimum PSA level required Measurable or evaluable disease An increase in PSA or pain without measurable or evaluable disease does not constitute hormone refractory disease PATIENT CHARACTERISTICS: Age: 18 and over Performance status: Karnofsky 60-100% ECOG 0-2 Life expectancy: At least 6 months Hematopoietic: Absolute neutrophil count at least 1,500/mm3 Platelet count at least 100,000/mm3 Hemoglobin at least 10 g/dL Hepatic: SGOT and SGPT no greater than 2 times upper limit of normal Bilirubin no greater than 2.0 mg/dL Renal: Creatinine no greater than 2.0 mg/dL Cardiovascular: LVEF normal No impaired cardiac status (e.g., history of severe heart disease, cardiomyopathy, or congestive heart failure) Other: No active infection, defined by the following: Clinical syndrome consistent with a viral or bacterial infection (e.g., influenza, upper respiratory infection, or urinary tract infection) Fever with a clinical site of infection identified Microbiologically documented infection including, but not limited to, bacteremia or septicemia HIV negative No other malignancy within the past 5 years except surgically cured basal cell or squamous cell skin cancer No psychiatric, addictive, or other disorder that would preclude informed consent or compliance No hypersensitivity to E. coli derived proteins or drugs formulated with polysorbate 80 (e.g., human insulin) PRIOR CONCURRENT THERAPY: Biologic therapy: No concurrent WBC transfusions No other concurrent biologic therapy Chemotherapy: See Disease Characteristics No other concurrent chemotherapy Endocrine therapy: See Disease Characteristics Radiotherapy: At least 4 weeks since prior radiotherapy Surgery: See Disease Characteristics Other: No other concurrent investigational agent No concurrent acetaminophen for fever prophylaxis

Sites / Locations

  • Wilshire Oncology Medical Group, Inc.
  • Geffen Cancer Center and Research Institute
  • Arena Oncology Associates
  • New York Medical College
  • N.W. Carolina Oncology & Hematology, P.A.
  • Associates of Hematology/Oncology

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
July 5, 2000
Last Updated
December 3, 2013
Sponsor
Amgen
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1. Study Identification

Unique Protocol Identification Number
NCT00005960
Brief Title
Combination Chemotherapy in Treating Patients With Prostate Cancer That Has Not Responded to Hormone Therapy
Official Title
A Phase II Study of Doxorubicin and Cyclophosphamide With Sequential Docetaxel in Patients With Hormone-Refractory Prostate Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
January 2001
Overall Recruitment Status
Unknown status
Study Start Date
October 1999 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Amgen

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. Giving more than one drug may kill more tumor cells. PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy in treating patients who have prostate cancer that has not responded to hormone therapy.
Detailed Description
OBJECTIVES: I. Determine the PSA response, duration of PSA response, disease free survival, median survival, and overall survival in patients with chemotherapy naive hormone refractory adenocarcinoma of the prostate treated with doxorubicin and cyclophosphamide with sequential docetaxel. II. Assess for any improvement in pain over time in patients treated with this regimen. OUTLINE: This is a multicenter study. Patients receive doxorubicin IV over 3-5 minutes and cyclophosphamide IV on days 1, 22, 43, and 64, and docetaxel IV over 1 hour on days 85, 106, and 127 in the absence of disease progression or unacceptable toxicity. Patients receive filgrastim (G-CSF) subcutaneously daily beginning 24 hours after completion of chemotherapy infusions and continuing until blood counts recover. G-CSF must be discontinued at least 24 hours prior to starting subsequent chemotherapy infusions. Pain and analgesic use are assessed before study, every 3 weeks during study, after completion of study, and then at 3 months after completion of study. Patients are followed every 3 months for 2 years, every 6 months for 2 years, and then annually thereafter until death. PROJECTED ACCRUAL: Approximately 42-105 patients will be accrued for this study over 18 months.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pain, Prostate Cancer
Keywords
adenocarcinoma of the prostate, stage I prostate cancer, stage IIB prostate cancer, stage IIA prostate cancer, stage III prostate cancer, stage IV prostate cancer, recurrent prostate cancer, pain

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2

8. Arms, Groups, and Interventions

Intervention Type
Biological
Intervention Name(s)
filgrastim
Intervention Type
Drug
Intervention Name(s)
cyclophosphamide
Intervention Type
Drug
Intervention Name(s)
docetaxel
Intervention Type
Drug
Intervention Name(s)
doxorubicin hydrochloride
Intervention Type
Procedure
Intervention Name(s)
pain therapy

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
DISEASE CHARACTERISTICS: Histologically proven adenocarcinoma of the prostate that is chemotherapy naive and refractory to hormonal therapy with combined androgen blockade No concurrent antiandrogen therapy withdrawal: Must continue antiandrogen therapy until completion of study OR Must discontinue flutamide at least 4 weeks before or bicalutamide at least 8 weeks before study enrollment, and must have disease progression off antiandrogen therapy, defined by serial increase in PSA (at least 2 measurements taken at least 2 weeks apart) or measurable tumor Concurrent LHRH antagonist allowed if no prior orchiectomy No minimum PSA level required Measurable or evaluable disease An increase in PSA or pain without measurable or evaluable disease does not constitute hormone refractory disease PATIENT CHARACTERISTICS: Age: 18 and over Performance status: Karnofsky 60-100% ECOG 0-2 Life expectancy: At least 6 months Hematopoietic: Absolute neutrophil count at least 1,500/mm3 Platelet count at least 100,000/mm3 Hemoglobin at least 10 g/dL Hepatic: SGOT and SGPT no greater than 2 times upper limit of normal Bilirubin no greater than 2.0 mg/dL Renal: Creatinine no greater than 2.0 mg/dL Cardiovascular: LVEF normal No impaired cardiac status (e.g., history of severe heart disease, cardiomyopathy, or congestive heart failure) Other: No active infection, defined by the following: Clinical syndrome consistent with a viral or bacterial infection (e.g., influenza, upper respiratory infection, or urinary tract infection) Fever with a clinical site of infection identified Microbiologically documented infection including, but not limited to, bacteremia or septicemia HIV negative No other malignancy within the past 5 years except surgically cured basal cell or squamous cell skin cancer No psychiatric, addictive, or other disorder that would preclude informed consent or compliance No hypersensitivity to E. coli derived proteins or drugs formulated with polysorbate 80 (e.g., human insulin) PRIOR CONCURRENT THERAPY: Biologic therapy: No concurrent WBC transfusions No other concurrent biologic therapy Chemotherapy: See Disease Characteristics No other concurrent chemotherapy Endocrine therapy: See Disease Characteristics Radiotherapy: At least 4 weeks since prior radiotherapy Surgery: See Disease Characteristics Other: No other concurrent investigational agent No concurrent acetaminophen for fever prophylaxis
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Debra Litwak, PharmD
Organizational Affiliation
Amgen
Official's Role
Study Chair
Facility Information:
Facility Name
Wilshire Oncology Medical Group, Inc.
City
Los Angeles
State/Province
California
ZIP/Postal Code
90057
Country
United States
Facility Name
Geffen Cancer Center and Research Institute
City
Vero Beach
State/Province
Florida
ZIP/Postal Code
32960-6541
Country
United States
Facility Name
Arena Oncology Associates
City
Great Neck
State/Province
New York
ZIP/Postal Code
11021
Country
United States
Facility Name
New York Medical College
City
Valhalla
State/Province
New York
ZIP/Postal Code
10595
Country
United States
Facility Name
N.W. Carolina Oncology & Hematology, P.A.
City
Hickory
State/Province
North Carolina
ZIP/Postal Code
28603
Country
United States
Facility Name
Associates of Hematology/Oncology
City
Upland
State/Province
Pennsylvania
ZIP/Postal Code
19013
Country
United States

12. IPD Sharing Statement

Learn more about this trial

Combination Chemotherapy in Treating Patients With Prostate Cancer That Has Not Responded to Hormone Therapy

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