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Chemotherapy Plus Hormone Therapy Versus Androgen Suppression in Treating Patients With Metastatic or Unresectable Prostate Cancer
This study is ongoing, but not recruiting participants.
First Received: November 1, 1999   Last Updated: July 25, 2009   History of Changes
Sponsor: M.D. Anderson Cancer Center
Collaborator: National Cancer Institute (NCI)
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00002855
  Purpose

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 Intervention Phase
Prostate Cancer
Drug: bicalutamide
Drug: doxorubicin hydrochloride
Drug: endocrine-modulating drug therapy
Drug: estramustine phosphate sodium
Drug: flutamide
Drug: ketoconazole
Drug: nilutamide
Drug: therapeutic hydrocortisone
Drug: vinblastine
Procedure: conventional surgery
Phase III

Study Type: Interventional
Study Design: Treatment, Randomized, Active Control
Official Title: A PHASE 3 TRIAL OF ANDROGEN ABLATION ALONE VS. CHEMO/HORMONAL THERAPY AS INITIAL TREATMENT OF UNRESECTABLE/METASTATIC ADENOCARCINOMA OF THE PROSTATE

Resource links provided by NLM:


Further study details as provided by National Cancer Institute (NCI):

Estimated Enrollment: 368
Study Start Date: August 1996
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.

  Eligibility

Genders 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
Please refer to this study by its ClinicalTrials.gov identifier: 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
Investigators
Study Chair: Randall E. Millikan, MD, PhD M.D. Anderson Cancer Center
  More Information

Additional Information:
Publications:
Study ID Numbers: CDR0000065105, MDA-DM-95231, NCI-G96-1044
Study First Received: November 1, 1999
Last Updated: July 25, 2009
ClinicalTrials.gov Identifier: NCT00002855     History of Changes
Health Authority: United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
adenocarcinoma of the prostate
stage III prostate cancer
stage IV prostate cancer
recurrent prostate cancer

Additional relevant MeSH terms:
Anti-Inflammatory Agents
Anti-Infective Agents
Hydrocortisone
Molecular Mechanisms of Pharmacological Action
Prostatic Diseases
Genital Neoplasms, Male
Antineoplastic Agents
Hormone Antagonists
Estramustine
Physiological Effects of Drugs
Hormones, Hormone Substitutes, and Hormone Antagonists
Urogenital Neoplasms
Vinblastine
Flutamide
Antibiotics, Antineoplastic
Hormones
Neoplasms by Site
Antifungal Agents
Therapeutic Uses
Alkylating Agents
Antineoplastic Agents, Hormonal
Cortisol succinate
Nilutamide
Mitosis Modulators
Antimitotic Agents
Genital Diseases, Male
Ketoconazole
Doxorubicin
Pharmacologic Actions
Androgen Antagonists

ClinicalTrials.gov processed this record on November 27, 2009