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Chemotherapy Plus Hormone Therapy Versus Androgen Suppression in Treating Patients With Metastatic or Unresectable Prostate Cancer

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ClinicalTrials.gov Identifier: NCT00002855
Recruitment Status : Completed
First Posted : January 27, 2003
Last Update Posted : July 30, 2012
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
M.D. Anderson Cancer Center

Study Description
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Brief Summary:

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.


Condition or disease Intervention/treatment Phase
Prostate Cancer Drug: Bicalutamide Drug: Doxorubicin hydrochloride Drug: Estramustine Phosphate Sodium Drug: Flutamide Drug: Ketoconazole Drug: Nilutamide Drug: Therapeutic Hydrocortisone Drug: Vinblastine Procedure: Conventional Surgery Phase 3

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 306 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 3 Trial of Androgen Ablation Alone vs. Chemo/Hormonal Therapy as Initial Treatment of Unresectable/Metastatic Adenocarcinoma of the Prostate
Study Start Date : August 1996
Actual Primary Completion Date : June 2005
Actual Study Completion Date : June 2005

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Prostate Cancer

Arms and Interventions
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Arm Intervention/treatment
Experimental: Arm I
Arm I: Medical or surgical castration followed by an anti-androgen therapy with either flutamide, bicalutamide, or nilutamide.
 Drug: Bicalutamide
Other Name: Casodex

Drug: Flutamide
Other Name: Eulexin

Drug: Nilutamide
Other Names:
  • Anandron
  • Nilandron

Procedure: Conventional Surgery
Surgical castration
Other Name: Castration
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.
 Drug: Doxorubicin hydrochloride
Other Names:
  • Adriamycin
  • Adriamycin PFS
  • Adriamycin RDF
  • Rubex

Drug: Estramustine Phosphate Sodium
Other Name: Emcyt

Drug: Ketoconazole
Other Name: Nizoral

Drug: Therapeutic Hydrocortisone
Other Names:
  • A-hydroCort
  • Cortef
  • Cortenema
  • Cortifoam
  • Hydrocortone
  • Solu-Cortef

Drug: Vinblastine
Other Name: Velban


Outcome Measures
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Primary Outcome Measures :
  1. Time to Progression [ Time Frame: From baseline to post treatment (minimally 24+ weeks) ]

Eligibility Criteria
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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00002855


Locations
United States, Texas
University of Texas - MD Anderson Cancer Center
Houston, Texas, United States, 77030-4009
Sponsors and Collaborators
M.D. Anderson Cancer Center
National Cancer Institute (NCI)
Investigators
Study Chair: Randall E. Millikan, MD, PhD M.D. Anderson Cancer Center
More Information
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Additional Information:
UT MD Anderson Cancer Center Website  This link exits the ClinicalTrials.gov site

Publications of Results:

Responsible Party: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT00002855     History of Changes
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 )
First Posted: January 27, 2003    Key Record Dates
Last Update Posted: July 30, 2012
Last Verified: July 2012

Keywords provided by M.D. Anderson Cancer Center:
adenocarcinoma of the prostate
stage III prostate cancer
stage IV prostate cancer
recurrent prostate cancer

Additional relevant MeSH terms:
Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases
Doxorubicin
Liposomal doxorubicin
Bicalutamide
Nilutamide
Vinblastine
Estramustine
Flutamide
Ketoconazole
 Androgens
Hydrocortisone 17-butyrate 21-propionate
Hydrocortisone acetate
Cortisol succinate
Hydrocortisone
Antibiotics, Antineoplastic
Antineoplastic Agents
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Anti-Inflammatory Agents