- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00002855
Chemotherapy Plus Hormone Therapy Versus Androgen Suppression in Treating Patients With Metastatic or Unresectable Prostate Cancer
A Phase 3 Trial of Androgen Ablation Alone vs. Chemo/Hormonal Therapy as Initial Treatment of Unresectable/Metastatic Adenocarcinoma of the Prostate
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining hormone therapy with chemotherapy and androgen suppression may kill more tumor cells. It is not yet known which treatment regimen is more effective for prostate cancer.
PURPOSE: Randomized phase III trial to compare the effectiveness of chemotherapy plus hormone therapy versus androgen suppression alone as initial therapy in patients with prostate cancer that is metastatic or that cannot be removed surgically.
Study Overview
Status
Conditions
Detailed Description
OBJECTIVES:
- Determine the clinical benefit, as measured by time to progression and overall survival, of chemo/hormonal therapy compared to androgen ablation alone, when given as the initial systemic treatment in patients with acinar adenocarcinoma of the prostate that is not amenable to local therapy.
- Validate the clinical significance of PSA criteria for progression.
OUTLINE: This is a randomized study. Patients are randomized to 1 of 2 treatment arms.
- Arm I: Patients are treated with medical or surgical castration followed by an anti-androgen therapy with either flutamide, bicalutamide, or nilutamide.
- Arm II: Patients receive chemo/hormonal therapy for 3 eight week courses, followed by total androgen blockade. Each course consists of 6 weeks of cytotoxic therapy with doxorubicin, ketoconazole, vinblastine, and estramustine followed by 2 weeks of rest. These patients are also maintained on hydrocortisone both during treatment and during rest.
Patients in arm II have a long-term central venous access device inserted.
PROJECTED ACCRUAL: A total of 368 patients will be accrued for this study.
Study Type
Enrollment (Actual)
Phase
- Phase 3
Contacts and Locations
Study Locations
-
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Texas
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Houston, Texas, United States, 77030-4009
- University of Texas - MD Anderson Cancer Center
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Genders Eligible for Study
Description
DISEASE CHARACTERISTICS:
- Histologically proven acinar adenocarcinoma of the prostate
- Metastatic or locally advanced disease that either is not appropriately treated with surgery or radiation, or has recurred following previous "definitive" local therapy
- No CNS metastases
- No histologic subtypes, such as pure ductal or any component of small cell carcinoma
- Elevated PSA (at least 1.0 ng/mL in patients with prior prostatectomy or 4.0 ng/mL in those with prostate in place)
PATIENT CHARACTERISTICS:
Age:
- Not specified
Performance status:
- Zubrod 0-2
Life expectancy:
- At least 3 years
Hematopoietic:
- Absolute neutrophil count greater than 1,500/mm^3
- Platelet count greater than 100,000/mm^3
Hepatic:
- Conjugated bilirubin no greater than 0.8 mg/dL or total bilirubin no greater than 1.5 mg/dL
- Transaminase no greater than 4 times upper limit of normal
Renal:
- Creatinine clearance at least 40 mL/min
Cardiovascular:
- No evidence of bifascicular block on EKG
- No evidence of active ischemia on EKG
- No prior history of transient ischemic attack
- No evidence of congestive heart failure
Other:
- No active peptic ulcer disease
- No regular use of antacid or H2 blockers
- No known or predicted achlorhydria
- No concurrent use of terfenadine, astemizole, omeprazole, or cisapride
- No second malignancy unless curatively treated
- No history of deep venous thrombosis
- No history of pulmonary embolism
- No serious co-morbidity
- HIV negative
PRIOR CONCURRENT THERAPY:
Biologic therapy:
- Not specified
Chemotherapy:
- No prior cytotoxic systemic therapy
Endocrine therapy:
- Prior androgen deprivation therapy allowed if given for no more than 6 months to downstage primary
- No androgen deprivation therapy within 1 year prior to study
Radiotherapy:
- No prior cytotoxic systemic therapy (including systemic strontium-89 irradiation)
- Prior definitive radiotherapy to the prostate and/or one metastatic site allowed
- At least 8 weeks since radiotherapy to the pelvis
- At least 3 weeks since radiotherapy to a single metastatic site
Surgery:
- Prior prostatectomy allowed
Other:
- No concurrent anti-anginal therapy or aggressive anticoagulants
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Arm I
Arm I: Medical or surgical castration followed by an anti-androgen therapy with either flutamide, bicalutamide, or nilutamide.
|
Other Names:
Other Names:
Other Names:
Surgical castration
Other Names:
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Experimental: Arm II
Arm II: Chemo/hormonal therapy for 3 x 8-week courses, followed by total androgen blockade.
Each course consists of 6 weeks of cytotoxic therapy with doxorubicin, ketoconazole, vinblastine, and estramustine followed by 2 weeks rest.
Maintained on hydrocortisone both during treatment and during rest.
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Other Names:
Other Names:
Other Names:
Other Names:
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Time to Progression
Time Frame: From baseline to post treatment (minimally 24+ weeks)
|
From baseline to post treatment (minimally 24+ weeks)
|
Collaborators and Investigators
Sponsor
Collaborators
Publications and helpful links
Helpful Links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Neoplasms
- Urogenital Neoplasms
- Neoplasms by Site
- Genital Neoplasms, Male
- Prostatic Diseases
- Prostatic Neoplasms
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Anti-Infective Agents
- Enzyme Inhibitors
- Anti-Inflammatory Agents
- Antineoplastic Agents
- Tubulin Modulators
- Antimitotic Agents
- Mitosis Modulators
- Hormones, Hormone Substitutes, and Hormone Antagonists
- Antineoplastic Agents, Hormonal
- Antineoplastic Agents, Alkylating
- Alkylating Agents
- Antineoplastic Agents, Phytogenic
- Topoisomerase II Inhibitors
- Topoisomerase Inhibitors
- Cytochrome P-450 CYP3A Inhibitors
- Cytochrome P-450 Enzyme Inhibitors
- Antibiotics, Antineoplastic
- Hormone Antagonists
- Antifungal Agents
- Steroid Synthesis Inhibitors
- Androgen Antagonists
- 14-alpha Demethylase Inhibitors
- Doxorubicin
- Liposomal doxorubicin
- Bicalutamide
- Ketoconazole
- Estramustine
- Hydrocortisone
- Hydrocortisone 17-butyrate 21-propionate
- Hydrocortisone acetate
- Hydrocortisone hemisuccinate
- Vinblastine
- Flutamide
- Nilutamide
Other Study ID Numbers
- DM95-231
- P30CA016672 (U.S. NIH Grant/Contract)
- MDA-DM-95231 (Other Identifier: UT MD Anderson Cancer Center)
- NCI-G96-1044
- CDR0000065105 (Registry Identifier: NCI PDQ)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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