Chemotherapy Plus Hormone Therapy Versus Androgen Suppression in Treating Patients With Metastatic or Unresectable Prostate Cancer
Information source: National Cancer Institute (NCI)
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Prostate Cancer
Intervention: bicalutamide (Drug); doxorubicin hydrochloride (Drug); estramustine phosphate sodium (Drug); flutamide (Drug); ketoconazole (Drug); nilutamide (Drug); therapeutic hydrocortisone (Drug); vinblastine (Drug); conventional surgery (Procedure); endocrine drug therapy (Procedure)
Phase: Phase 3
Status: Active, not recruiting
Sponsored by: M.D. Anderson Cancer Center
Official(s) and/or principal investigator(s):
Randall E. Millikan, MD, PhD, Study Chair, Affiliation: M.D. Anderson Cancer Center
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.
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 design: Treatment, Randomized, Active Control
- 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
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.
Minimum age: N/A.
Maximum age: N/A.
- 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)
- Not specified
- Zubrod 0-2
- At least 3 years
- Absolute neutrophil count greater than 1,500/mm^3
- Platelet count greater than 100,000/mm^3
- Conjugated bilirubin no greater than 0. 8 mg/dL or total bilirubin no greater than 1. 5
- Transaminase no greater than 4 times upper limit of normal
- Creatinine clearance at least 40 mL/min
- 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
- 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:
- Not specified
- No prior cytotoxic systemic therapy
- Prior androgen deprivation therapy allowed if given for no more than 6 months to
- No androgen deprivation therapy within 1 year prior to study
- 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
- Prior prostatectomy allowed
- No concurrent anti-anginal therapy or aggressive anticoagulants
Locations and Contacts
University of Texas - MD Anderson Cancer Center, Houston, Texas 77030-4009, United States
Clinical trial summary from the National Cancer Institute's PDQ® database
Starting date: August 1996
Last updated: May 23, 2008