Back to resultsDocetaxel, Doxorubicin, and Prednisone in Treating Patients With Advanced Prostate Cancer That Has Not Responded to Hormone Therapy
Primary Purpose
Prostate Cancer
Status
Completed
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
docetaxel
doxorubicin hydrochloride
prednisone
Sponsored by
About this trial
This is an interventional treatment trial for Prostate Cancer focused on measuring recurrent prostate cancer, stage III prostate cancer, stage IV prostate cancer, adenocarcinoma of the prostate
Eligibility Criteria
DISEASE CHARACTERISTICS:
Histologically confirmed adenocarcinoma of the prostate with any of the following:
- Prostate-specific antigen ≥ 10 mg/dL
- Bone disease
- Bidimensional soft tissue disease
- Evaluable disease
- Advanced disease AND failed prior primary androgen ablation therapy, including anti-androgen withdrawal
- Disease not amenable to local curative treatment
- No known brain metastases
PATIENT CHARACTERISTICS:
- ECOG performance status 0-1
- Absolute neutrophil count ≥ 1,500/mm^3
- Platelet count ≥ 100,000/mm^3
- Creatinine < 2.0 mg/dL
- SGPT and SGOT < 1.5 times upper limit of normal (ULN)
- Bilirubin ≤ ULN
- Hemoglobin ≥ 10 g/dL
- Ejection fraction ≥ 50%
- Peripheral neuropathy ≤ grade 1
- Fertile patients must use effective contraception during and for 3 months after completion of study treatment
No previous history of or concurrent malignancy, except for any of the following:
- Inactive nonmelanoma skin cancer
- Disease-free for five or more years
- Adequately treated stage I or II cancer from which patient is currently in complete remission
- No other serious medical illness that would limit survival to less than 3 months
- No psychiatric condition that would prevent informed consent
- No active, uncontrolled bacterial, viral, or fungal infection
- No hemorrhagic disorder
- No history of severe hypersensitivity reaction to other drugs formulated with polysorbate 80
PRIOR CONCURRENT THERAPY:
- See Disease Characteristics
- No new hormonal treatment within the past 4 weeks
- No prior immunotherapy, chemotherapy, or bone-seeking radiopharmaceuticals (e.g., strontium chloride Sr 89 or samarium Sm 153 lexidronam pentasodium)
- Prior bisphosphonates allowed
- At least 2 weeks since prior radiotherapy
- No other concurrent chemotherapy
Sites / Locations
Outcomes
Primary Outcome Measures
Secondary Outcome Measures
Full Information
NCT ID
NCT00416533
First Posted
December 27, 2006
Last Updated
January 17, 2017
Sponsor
Wake Forest University Health Sciences
Collaborators
National Cancer Institute (NCI)
1. Study Identification
Unique Protocol Identification Number
NCT00416533
Brief Title
Docetaxel, Doxorubicin, and Prednisone in Treating Patients With Advanced Prostate Cancer That Has Not Responded to Hormone Therapy
Official Title
A Phase II Study of Taxotere (Docetaxel) Plus Adriamycin (Doxorubicin) and Prednisone (TAP) in Hormone-Refractory Prostate Cancer
Study Type
Interventional
2. Study Status
Record Verification Date
June 2013
Overall Recruitment Status
Completed
Study Start Date
August 2004 (undefined)
Primary Completion Date
October 2006 (Actual)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Wake Forest University Health Sciences
Collaborators
National Cancer Institute (NCI)
4. Oversight
5. Study Description
Brief Summary
RATIONALE: Drugs used in chemotherapy, such as docetaxel, doxorubicin, and prednisone, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more tumor cells.
PURPOSE: This phase II trial is studying how well giving docetaxel, doxorubicin, and prednisone together works in treating patients with advanced prostate cancer that has not responded to hormone therapy.
Detailed Description
OBJECTIVES:
Primary
Assess prostate specific antigen response rate to docetaxel, doxorubicin hydrochloride, and prednisone in patients with hormone-refractory advanced prostate cancer.
Secondary
Assess if treatment with docetaxel, doxorubicin hydrochloride, and prednisone will improve health-related quality of life of these patients.
Assess the toxicity of docetaxel, doxorubicin hydrochloride, and prednisone.
Assess response rate in measurable disease.
OUTLINE: Patients receive docetaxel IV over 1 hour on day 1, doxorubicin hydrochloride IV over 15 minutes on days 1 and 8, and oral prednisone once daily on days 1-21. Treatment repeats every 21 days for at least 3 courses in the absence of disease progression or unacceptable toxicity.
Quality of life is assessed at baseline, on day 1 of each course, after completion of 3 courses, and at disease progression.
After completing study treatment, patients are followed every 6 months for 1 year.
PROJECTED ACCRUAL: A total of 47 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
recurrent prostate cancer, stage III prostate cancer, stage IV prostate cancer, adenocarcinoma of the prostate
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Masking
None (Open Label)
Enrollment
47 (Anticipated)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
docetaxel
Intervention Type
Drug
Intervention Name(s)
doxorubicin hydrochloride
Intervention Type
Drug
Intervention Name(s)
prednisone
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
120 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
DISEASE CHARACTERISTICS:
Histologically confirmed adenocarcinoma of the prostate with any of the following:
Prostate-specific antigen ≥ 10 mg/dL
Bone disease
Bidimensional soft tissue disease
Evaluable disease
Advanced disease AND failed prior primary androgen ablation therapy, including anti-androgen withdrawal
Disease not amenable to local curative treatment
No known brain metastases
PATIENT CHARACTERISTICS:
ECOG performance status 0-1
Absolute neutrophil count ≥ 1,500/mm^3
Platelet count ≥ 100,000/mm^3
Creatinine < 2.0 mg/dL
SGPT and SGOT < 1.5 times upper limit of normal (ULN)
Bilirubin ≤ ULN
Hemoglobin ≥ 10 g/dL
Ejection fraction ≥ 50%
Peripheral neuropathy ≤ grade 1
Fertile patients must use effective contraception during and for 3 months after completion of study treatment
No previous history of or concurrent malignancy, except for any of the following:
Inactive nonmelanoma skin cancer
Disease-free for five or more years
Adequately treated stage I or II cancer from which patient is currently in complete remission
No other serious medical illness that would limit survival to less than 3 months
No psychiatric condition that would prevent informed consent
No active, uncontrolled bacterial, viral, or fungal infection
No hemorrhagic disorder
No history of severe hypersensitivity reaction to other drugs formulated with polysorbate 80
PRIOR CONCURRENT THERAPY:
See Disease Characteristics
No new hormonal treatment within the past 4 weeks
No prior immunotherapy, chemotherapy, or bone-seeking radiopharmaceuticals (e.g., strontium chloride Sr 89 or samarium Sm 153 lexidronam pentasodium)
Prior bisphosphonates allowed
At least 2 weeks since prior radiotherapy
No other concurrent chemotherapy
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Frank M. Torti, MD, MPH
Organizational Affiliation
Wake Forest University Health Sciences
Official's Role
Study Chair
12. IPD Sharing Statement
Learn more about this trial
Docetaxel, Doxorubicin, and Prednisone in Treating Patients With Advanced Prostate Cancer That Has Not Responded to Hormone Therapy
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