Hormone Therapy Plus Chemotherapy in Treating Patients With 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); docetaxel (Drug); doxorubicin hydrochloride (Drug); estramustine phosphate sodium (Drug); flutamide (Drug); ketoconazole (Drug); paclitaxel (Drug); vinblastine (Drug); releasing hormone agonist therapy (Procedure)
Phase: Phase 3
Status: Active, not recruiting
Sponsored by: Radiation Therapy Oncology Group Official(s) and/or principal investigator(s):
Kenneth J. Pienta, MD, FACP, Study Chair, Affiliation: University of Michigan Cancer Center
Naomi S. Balzer-Haas, MD, Study Chair, Affiliation: Fox Chase Cancer Center
Arif Hussain, MD, Study Chair, Affiliation: University of Maryland Greenebaum Cancer Center
Gregory P. Swanson, MD, Study Chair, Affiliation: Deaconess Medical Center, Spokane, Washington
Primo N. Lara, MD, Affiliation: University of California, Davis
Summary
RATIONALE: Androgens can stimulate the growth of prostate cancer cells. Drugs such as
luteinizing hormone-releasing hormone agonist, flutamide, and bicalutamide may stop the
adrenal glands from producing androgens. Drugs used in chemotherapy work in different ways to
stop tumor cells from dividing so they stop growing or die. Combining hormone therapy with
chemotherapy may kill more tumor cells. It is not yet known whether chemotherapy given at the
same time as hormone therapy is more effective than chemotherapy given after hormone therapy
in treating prostate cancer.
PURPOSE: Randomized phase III trial to compare the effectiveness of chemotherapy given at the
same time as hormone therapy with that of chemotherapy given after hormone therapy in
treating patients who have prostate cancer.
Clinical Details
Official title: A Phase III Randomized Study of Patients With High Risk, Hormone-Naive Prostate Cancer: Androgen Blockade With 4 Cycles of Immediate Chemotherapy Versus Androgen Blockade With Delayed Chemotherapy
Study design: Treatment, Randomized, Active Control
Detailed description:
OBJECTIVES:
Primary
- Compare the survival of patients with high-risk hormone-naive prostate cancer treated
with androgen blockade with concurrent chemotherapy vs delayed chemotherapy.
Secondary
- Compare biochemical control in patients treated with these regimens.
- Determine the toxicity of these regimens in these patients.
- Compare the time to clinical failure, as measured by progression on bone scan or CT scan
or a prostate-specific antigen doubling time of ≤ 32 weeks, in patients treated with
these regimens.
OUTLINE: This is a randomized, multicenter study. Patients are stratified according to prior
therapy (surgery vs radiotherapy and/or brachytherapy vs both), original combined Gleason
score (6 vs 7 vs 8-10), and prior vaccine therapy (yes vs no). Patients are randomized to 1
of 2 treatment arms.
- Arm I: Patients receive androgen blockade (AB) comprising a luteinizing-hormone
releasing-hormone agonist continuously and oral flutamide or oral bicalutamide once
daily for at least 1 month. Within 4 weeks of initiation of AB, patients begin
chemotherapy. Patients receive 1, and only 1, of the following chemotherapy regimens:
- Regimen A: Patients receive oral estramustine 3 times daily on days 1-5 and
docetaxel IV on day 3. Treatment repeats every 21 days for 4 courses in the absence
of disease progression or unacceptable toxicity.
- Regimen B: Patients receive oral estramustine 3 times daily on days 1-5 and
paclitaxel IV on days 3, 10, 17, 24, 31, and 38. Treatment repeats every 56 days
for 4 courses in the absence of disease progression or unacceptable toxicity.
- Regimen C: Patients receive oral ketoconazole 3 times daily on days 1-7, 15-21, and
29-35; doxorubicin IV on days 1, 15, and 29; vinblastine IV on days 8, 22, and 36;
and oral estramustine 3 times daily on days 8-14, 22-28, and 36-42. Treatment
repeats every 56 days for 4 courses in the absence of disease progression or
unacceptable toxicity.
- Regimen D: Patients receive oral estramustine 3 times daily on days 1-4 and
docetaxel IV over 1 hour on days 3, 10, and 17. Treatment repeats every 28 days for
4 courses in the absence of disease progression or unacceptable toxicity.
- Regimen E: Patients receive docetaxel IV on day 1. Treatment repeats every 21 days
for 4 courses in the absence of disease progression or unacceptable toxicity.
- Regimen F: Patients receive docetaxel IV on days 1, 8, and 15. Treatment repeats
every 28 days for 4 courses in the absence of disease progression or unacceptable
toxicity.
- Regimen G: With approval from the protocol chair, patients may receive a regimen
that has been demonstrated in a published phase II study to have at least a 50%
response rate as measured by PSA decrease from baseline over 2 measurements 28 days
apart or a decrease in measurable soft tissue disease by 50% in 2 dimensions.
- Arm II: Patients receive AB as in arm I. Patients continue with AB until clinical
failure, at which time patients receive chemotherapy as in arm I. Patients who have a
response may continue to receive chemotherapy beyond 4 courses.
Patients are followed every 3 months for 2 years, every 6 months for 3 years, and then
annually thereafter.
PROJECTED ACCRUAL: A total of 1,050 patients will be accrued for this study within 4-6
years.
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Male.
Criteria:
DISEASE CHARACTERISTICS:
- Diagnosis of adenocarcinoma of the prostate
- Failed local treatments (surgery and/or radiotherapy and/or brachytherapy) as
defined by a rising prostate-specific antigen level of at least 2. 0 ng/mL
(confirmed by 2 measurements at least 2 weeks apart) and a doubling time of 32
weeks or less
- No clinical or radiographic evidence of disease
- Original Gleason score of at least 7 OR Gleason score of 6 with capsular
penetration or positive seminal vesicles or lymph nodes
- No metastases
PATIENT CHARACTERISTICS:
Age:
- 18 and over
Performance status:
- Zubrod 0-1
Life expectancy:
- Not specified
Hematopoietic:
- Absolute granulocyte count at least 1,500/mm^3
- Platelet count at least 100,000/mm^3
- Hemoglobin at least 10 g/dL
- No history of bleeding disorders that would contraindicate warfarin, including
clotting factor defects
Hepatic:
- Bilirubin no greater than 1. 5 mg/dL
- AST/ALT no greater than 1. 5 times upper limit of normal
Renal:
- Creatinine no greater than 1. 5 mg/dL
- BUN no greater than 1. 2 times normal
Cardiovascular:
- No symptomatic heart disease
- No history of myocardial infarction
- No history of thromboembolic events (e. g., deep vein thrombosis, symptomatic
cerebrovascular events, or pulmonary embolism)
Other:
- No other major medical or psychiatric illness that would preclude study entry
- No other prior or concurrent invasive malignancy within the past 5 years except
superficial skin cancer
- No history of esophageal varices
- Fertile patients must use effective contraception
PRIOR CONCURRENT THERAPY:
Biologic therapy:
- At least 6 weeks since prior vaccine therapy
Chemotherapy:
- At least 5 years since prior chemotherapy
Endocrine therapy:
- Prior adjuvant or neoadjuvant hormonal therapy of less than 8 months duration allowed
- At least 1 year since prior androgen therapy
Radiotherapy:
- See Disease Characteristics
- At least 5 years since prior radiotherapy to sites other than prostate
Surgery:
- See Disease Characteristics
Other:
- Concurrent warfarin allowed
- Concurrent bisphosphonate therapy initiated prior to or after randomization allowed
Locations and Contacts
Instituto de Enfermedades Neoplasicas, Lima 34, Peru
San Juan City Hospital, San Juan 00936-7344, Puerto Rico
Foundation for Cancer Research and Education, Phoenix, Arizona 85013, United States
Veterans Affairs Medical Center - Tucson, Tucson, Arizona 85723, United States
Veterans Affairs Medical Center - Little Rock, Little Rock, Arkansas 72205, United States
Veterans Affairs Outpatient Clinic - Martinez, Martinez, California 94553, United States
Boulder Community Hospital, Boulder, Colorado 80301-9019, United States
CCOP - Colorado Cancer Research Program, Incorporated, Denver, Colorado 80224, United States
Hope Cancer Care Center at Longmont United Hospital, Longmont, Colorado 80501, United States
Medical Center of Aurora - South Campus, Aurora, Colorado 80012-0000, United States
Memorial Hospital Cancer Center, Colorado Springs, Colorado 80909, United States
Penrose Cancer Center at Penrose Hospital, Colorado Springs, Colorado 80933, United States
Porter Adventist Hospital, Denver, Colorado 80210, United States
Presbyterian - St. Luke's Medical Center, Denver, Colorado 80218, United States
Rocky Mountain Cancer Centers - Denver Rose, Denver, Colorado 80220, United States
Rocky Mountain Cancer Centers - Thornton, Thornton, Colorado 80221, United States
Sky Ridge Medical Center, Lone Tree, Colorado 80124, United States
St. Joseph Hospital, Denver, Colorado 80218-1191, United States
St. Mary-Corwin Regional Medical Center, Pueblo, Colorado 81004, United States
Swedish Medical Center, Englewood, Colorado 80112, United States
Gulf Coast Cancer Treatment Center, Panama City, Florida 32405-4587, United States
Shands Cancer Center at the University of Florida Health Science Center, Gainesville, Florida 32610-0385, United States
Tallahassee Memorial Hospital, Tallahassee, Florida 32308, United States
University of Miami Sylvester Comprehensive Cancer Center, Miami, Florida 33136, United States
Veterans Affairs Medical Center - Tampa (Haley), Tampa, Florida 33612, United States
Saint Alphonsus Cancer Care Center at Saint Alphonsus Regional Medical Center, Boise, Idaho 83706, United States
Veterans Affairs Medical Center - Hines, Hines, Illinois 60141, United States
John Stoddard Cancer Center at Iowa Lutheran Hospital, Des Moines, Iowa 50316-2301, United States
John Stoddard Cancer Center at Iowa Methodist Medical Center, Des Moines, Iowa 50309, United States
Mercy Cancer Center at Mercy Medical Center - Des Moines, Des Moines, Iowa 50314, United States
Wendt Regional Cancer Center at Finley Hospital, Dubuque, Iowa 52001, United States
Veterans Affairs Medical Center - Wichita, Wichita, Kansas 67218, United States
Veterans Affairs Medical Center - Lexington, Lexington, Kentucky 40502-2236, United States
Veterans Affairs Medical Center - New Orleans, New Orleans, Louisiana 70112, United States
Veterans Affairs Medical Center - Shreveport, Shreveport, Louisiana 71101-4295, United States
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins, Baltimore, Maryland 21231, United States
University of Michigan Comprehensive Cancer Center, Ann Arbor, Michigan 48109-0010, United States
Veterans Affairs Medical Center - Detroit, Detroit, Michigan 48201-1932, United States
West Michigan Cancer Center, Kalamazoo, Michigan 49007, United States
Veterans Affairs Medical Center - Jackson, Jackson, Mississippi 39216, United States
Cancer Research for the Ozarks, Springfield, Missouri 65807, United States
Midlands Cancer Center at Midlands Community Hospital, Papillion, Nebraska 68128-4157, United States
MBCCOP - University of New Mexico HSC, Albuquerque, New Mexico 87131, United States
Veterans Affairs Medical Center - Albuquerque, Albuquerque, New Mexico 87108-5138, United States
Westmead Hospital, Westmead, New South Wales 2145, Australia
Lipson Cancer and Blood Center at Rochester General Hospital, Rochester, New York 14621, United States
NYU School of Medicine's Kaplan Comprehensive Cancer Center, New York, New York 10016, United States
CCOP - Southeast Cancer Control Consortium, Goldsboro, North Carolina 27534-9479, United States
Akron City Hospital at Summa Health System, Akron, Ohio 44304, United States
Akron General's McDowell Cancer Center, Akron, Ohio 44302, United States
Cancer Care Center, Incorporated, Salem, Ohio 44460, United States
Cancer Treatment Center, Wooster, Ohio 44691, United States
Veterans Affairs Medical Center - Cincinnati, Cincinnati, Ohio 45220-2288, United States
Veterans Affairs Medical Center - Dayton, Dayton, Ohio 45428-1002, United States
Veterans Affairs Medical Center - Portland, Portland, Oregon 97207, United States
Fox Chase Cancer Center, Philadelphia, Pennsylvania 19111, United States
Mercy Fitzgerald Hospital, Darby, Pennsylvania 19023, United States
Mercy Hospital Cancer Center - Scranton, Scranton, Pennsylvania 18501, United States
Penn State Cancer Institute at Milton S. Hershey Medical Center, Hershey, Pennsylvania 17033-0850, United States
CCOP - Greenville, Greenville, South Carolina 29615, United States
Veterans Affairs Medical Center - Charleston, Charleston, South Carolina 29401-5799, United States
Rapid City Regional Hospital, Rapid City, South Dakota 57709, United States
Erlanger Cancer Center, Chattanooga, Tennessee 37403, United States
Vanderbilt-Ingram Cancer Center at Vanderbilt Medical Center, Nashville, Tennessee 37232-5671, United States
Veterans Affairs Medical Center - Memphis, Memphis, Tennessee 38104, United States
University of Texas Medical Branch, Galveston, Texas 77555-0209, United States
Veterans Affairs Medical Center - Amarillo, Amarillo, Texas 79106, United States
Veterans Affairs Medical Center - San Antonio (Murphy), San Antonio, Texas 78229, United States
Veterans Affairs Medical Center - Temple, Temple, Texas 76504, United States
Cottonwood Hospital Medical Center, Murray, Utah 84107, United States
Dixie Regional Medical Center, Saint George, Utah 84770, United States
McKay-Dee Hospital Center, Ogden, Utah 84403, United States
Utah Valley Regional Medical Center - Provo, Provo, Utah 84604, United States
Veterans Affairs Medical Center - Salt Lake City, Salt Lake City, Utah 84148, United States
Veterans Affairs Medical Center - Seattle, Seattle, Washington 98108, United States
All Saints Cancer Center at All Saints Healthcare, Racine, Wisconsin 53405, United States
CCOP - Marshfield Clinic Research Foundation, Marshfield, Wisconsin 54449, United States
CCOP - St. Vincent Hospital Cancer Center, Green Bay, Green Bay, Wisconsin 54301, United States
Additional Information
Clinical trial summary from the National Cancer Institute's PDQ® database
Related publications: Sandler HM, Pienta KJ. Rationale for the Radiation Therapy Oncology Group Study RTOG P-0014. Rev Urol. 2003;5 Suppl 2:S28-34.
Starting date: October 2002
Last updated: May 23, 2008
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