Hormone Therapy Plus Radiation Therapy With or Without Combination Chemotherapy in Treating Patients With Prostate Cancer - Full Text View

Sponsor:	Radiation Therapy Oncology Group
Collaborator:	National Cancer Institute (NCI)
Information provided by:	National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:	NCT00004054

Purpose

RATIONALE: Hormones can stimulate the production of prostate cancer cells. Hormone therapy may fight prostate cancer by reducing the production of androgens. Radiation therapy uses high-energy x-rays to damage tumor cells. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. It is not yet known whether hormone therapy plus radiation therapy is more effective with or without combination chemotherapy for prostate cancer.

PURPOSE: Randomized phase III trial to compare the effectiveness of hormone therapy plus radiation therapy with or without combination chemotherapy in treating patients who have prostate cancer.

Condition	Intervention	Phase
Prostate Cancer	Drug: bicalutamide Drug: estramustine phosphate sodium Drug: etoposide Drug: flutamide Drug: paclitaxel Drug: releasing hormone agonist therapy Radiation: radiation therapy	Phase III

Study Type:	Interventional
Study Design:	Treatment, Randomized, Active Control
Official Title:	A Phase III Protocol of Androgen Suppression (AS) and Radiation Therapy (RT) vs AS and RT Followed by Chemotherapy With Paclitaxel, Estramustine, and Etoposide (TEE) for Localized, High-Risk, Prostate Cancer

Resource links provided by NLM:

MedlinePlus related topics: Cancer Prostate Cancer

Drug Information available for: Flutamide Paclitaxel Etoposide Estramustine phosphate sodium Bicalutamide Etoposide phosphate Estramustine Estramustine phosphate

U.S. FDA Resources

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

Estimated Enrollment:	1440
Study Start Date:	January 2000

Detailed Description:

OBJECTIVES:

Compare the efficacy of androgen suppression and radiotherapy with or without subsequent paclitaxel, estramustine, and etoposide, in terms of overall and disease-free survival, biochemical and local control, and freedom from distant metastasis, in patients with localized high-risk prostate cancer.
Compare the toxic effects of these regimens in these patients.

OUTLINE: This is a randomized study. Patients are stratified according to prostate-specific antigen level (≤ 10 ng/mL vs 11-100 ng/mL), tumor stage (T1-2 vs T3-4), Gleason score (7 vs 8-10), and prior hormone use (yes vs no). Patients are randomized to one of two treatment arms.

All patients receive androgen suppression comprising a luteinizing hormone-releasing hormone (LHRH) agonist AND bicalutamide OR flutamide for 4 months. Beginning 8 weeks after the initiation of androgen suppression, all patients undergo radiotherapy once daily, 5 days a week, for 7-8 weeks. Patients who received prior androgen suppression therapy count time to radiotherapy from start date of prior hormonal therapy.

Arm I: Patients continue androgen suppression therapy (LHRH agonist only) for approximately 20 more months after radiotherapy is completed.
Arm II: Patients continue therapy as in arm I and receive chemotherapy beginning 28 days after completing radiotherapy. Chemotherapy comprises oral estramustine 3 times daily and oral etoposide twice daily on days 1-14 and paclitaxel IV over 1 hour on day 2. Chemotherapy repeats every 21 days for 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 1,440 patients will be accrued for this study within 6 years.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Male
Accepts Healthy Volunteers:	No

Criteria

DISEASE CHARACTERISTICS:

Histologically proven prostate cancer at high risk for relapse as determined by either of the following:
- Prostate-specific antigen (PSA) 20-100 ng/mL and Gleason score at least 7 (any T stage)
- Clinical stage at least T2, Gleason score at least 8, and PSA no greater than 100 ng/mL
Negative lymph nodes
No metastatic disease

PATIENT CHARACTERISTICS:

Age:

Over 18

Performance status:

Zubrod 0 or 1

Life expectancy:

Not specified

Hematopoietic:

WBC at least 3,000/mm^3
Platelet count at least 130,000/mm^3
Hemoglobin at least 11.4 g/dL

Hepatic:

AST no greater than 2 times upper limit of normal

Renal:

Creatinine no greater than 2.5 mg/dL

Other:

No other invasive cancer within the past 5 years except superficial nonmelanomatous skin cancer
No major medical or psychiatric illness that would preclude study participation
Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY:

Biologic therapy:

Not specified

Chemotherapy:

At least 5 years since prior chemotherapy

Endocrine therapy:

At least 60 days since prior finasteride for prostatic hypertrophy
At least 90 days since prior testosterone
No more than 30 days since initiation of prior pharmacologic androgen ablation for prostate cancer

Radiotherapy:

No prior pelvic radiotherapy
No concurrent intensity-modulated radiotherapy

Surgery:

No prior radical prostatectomy
No prior cryosurgery for prostate cancer
No prior orchiectomy

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00004054

Hide Study Locations

Locations

United States, Alabama
University of Alabama at Birmingham Comprehensive Cancer Center
Birmingham, Alabama, United States, 35294-3300
United States, Arizona
Foundation for Cancer Research and Education
Phoenix, Arizona, United States, 85013
United States, California
CCOP - Santa Rosa Memorial Hospital
Santa Rosa, California, United States, 95403
Mount Diablo Medical Center
Concord, California, United States, 94524-4110
Sutter Health Western Division Cancer Research Group
Greenbrae, California, United States, 94904
United States, Colorado
University of Colorado Cancer Center at University of Colorado Health Sciences Center
Denver, Colorado, United States, 80010
United States, Florida
Baptist Hospital of Miami
Miami, Florida, United States, 33176-2197
United States, Illinois
Lutheran General Cancer Care Center
Park Ridge, Illinois, United States, 60068
United States, Indiana
Ball Memorial Hospital Cancer Center
Muncie, Indiana, United States, 47303-3499
Methodist Cancer Center at Methodist Hospital
Indianapolis, Indiana, United States, 46206-1367
United States, Kentucky
Markey Cancer Center at University of Kentucky Chandler Medical Center
Lexington, Kentucky, United States, 40536-0293
United States, Louisiana
CCOP - Ochsner
New Orleans, Louisiana, United States, 70121
Mary Bird Perkins Cancer Center
Baton Rouge, Louisiana, United States, 70809
United States, Maryland
Anne Arundel Oncology Center
Annapolis, Maryland, United States, 21401
Greater Baltimore Medical Center and Cancer Center
Baltimore, Maryland, United States, 21204
United States, Michigan
Marquette General Hospital
Marquette, Michigan, United States, 49855
University of Michigan Comprehensive Cancer Center
Ann Arbor, Michigan, United States, 48109-0010
West Michigan Cancer Center
Kalamazoo, Michigan, United States, 49007
United States, Minnesota
CCOP - Metro-Minnesota
Saint Louis Park, Minnesota, United States, 55416
United States, Missouri
Ellis Fischel Cancer Center at University of Missouri - Columbia
Columbia, Missouri, United States, 65203
United States, Nevada
CCOP - Southern Nevada Cancer Research Foundation
Las Vegas, Nevada, United States, 89106
United States, New Jersey
Atlantic City Medical Center
Pomona, New Jersey, United States, 08240
Fox Chase Cancer Center at St. Francis Medical Center
Trenton, New Jersey, United States, 08629
Monmouth Medical Center
Long Branch, New Jersey, United States, 07740-6395
South Jersey Regional Cancer Center
Millville, New Jersey, United States, 08332
Veterans Affairs Medical Center - East Orange
East Orange, New Jersey, United States, 07019
United States, New York
CCOP - North Shore University Hospital
Manhasset, New York, United States, 11030
Herbert Irving Comprehensive Cancer Center at Columbia University
New York, New York, United States, 10032
United States, Ohio
Akron City Hospital
Akron, Ohio, United States, 44304
Akron General Medical Center
Akron, Ohio, United States, 44302
Arthur G. James Cancer Hospital - Ohio State University
Columbus, Ohio, United States, 43210-1240
CCOP - Toledo Community Hospital
Toledo, Ohio, United States, 43623-3456
CCOP - Dayton
Dayton, Ohio, United States, 45429
CCOP - Columbus
Columbus, Ohio, United States, 43206
United States, Pennsylvania
St. Luke's Hospital Cancer Center
Bethlehem, Pennsylvania, United States, 18015
CCOP - MainLine Health
Wynnewood, Pennsylvania, United States, 19096
Delaware County Memorial Hospital
Drexel Hill, Pennsylvania, United States, 19026
Fox Chase Cancer Center
Philadelphia, Pennsylvania, United States, 19111
John and Dorothy Morgan Cancer Center at Lehigh Valley Hospital
Allentown, Pennsylvania, United States, 18105
Kimmel Cancer Center at Thomas Jefferson University - Philadelphia
Philadelphia, Pennsylvania, United States, 19107-5541
Albert Einstein Cancer Center
Philadelphia, Pennsylvania, United States, 19141-3098
Wellspan Health - York Cancer Center
York, Pennsylvania, United States, 17403
United States, Texas
University of Texas - MD Anderson Cancer Center
Houston, Texas, United States, 77030-4009
United States, Utah
Dixie Regional Medical Center
Saint George, Utah, United States, 84770
LDS Hospital
Salt Lake City, Utah, United States, 84143
United States, Washington
University Cancer Center at University of Washington Medical Center
Seattle, Washington, United States, 98195-6043
United States, Wisconsin
All Saints Cancer Center at All Saints Healthcare
Racine, Wisconsin, United States, 53405
CCOP - St. Vincent Hospital Cancer Center, Green Bay
Green Bay, Wisconsin, United States, 54301
Gundersen Lutheran Cancer Center at Gundersen Lutheran Medical Center
La Crosse, Wisconsin, United States, 54601
Medical College of Wisconsin Cancer Center
Milwaukee, Wisconsin, United States, 53226
St. Luke's Medical Center
Milwaukee, Wisconsin, United States, 53215
St. Vincent Hospital
Green Bay, Wisconsin, United States, 54307-3508
Canada, New Brunswick
Saint John Regional Hospital
Saint John, New Brunswick, Canada, E2L 4L2
Canada, Ontario
Cancer Care Ontario-London Regional Cancer Centre
London, Ontario, Canada, N6A 4L6

Sponsors and Collaborators

Radiation Therapy Oncology Group

National Cancer Institute (NCI)

Investigators

Study Chair:

Howard M. Sandler, MD

University of Michigan Cancer Center

More Information

Additional Information:

Clinical trial summary from the National Cancer Institute's PDQ® database This link exits the ClinicalTrials.gov site

Publications:

Rosenthal SA, Bae K, Pienta KJ, Sobczak ML, Asbell SO, Rajan R, Kerlin KJ, Michalski JM, Sandler HM. Phase III Multi-Institutional Trial of Adjuvant Chemotherapy with Paclitaxel, Estramustine, and Oral Etoposide Combined with Long-Term Androgen Suppression Therapy and Radiotherapy Versus Long-Term Androgen Suppression Plus Radiotherapy Alone For High-Risk Prostate Cancer: Preliminary Toxicity Analysis of RTOG 99-02. Int J Radiat Oncol Biol Phys. 2008 Nov 4; [Epub ahead of print]

Sandler HM, DeSilvio M, Pienta KJ, et al.: Preliminary analysis of RTOG 9902: increased toxicity observed with the use of adjuvant chemotherapy. [Abstract] 2006 Prostate Cancer Symposium, February 24-26, 2006, San Francisco, CA. A-190, 2006.

Study ID Numbers:	CDR0000067250, RTOG-9902, RTOG-DEV-1020
Study First Received:	December 10, 1999
Last Updated:	February 6, 2009
ClinicalTrials.gov Identifier:	NCT00004054 History of Changes
Health Authority:	United States: Federal Government

Keywords provided by National Cancer Institute (NCI):

stage II prostate cancer
stage III prostate cancer
stage IV prostate cancer

Additional relevant MeSH terms:

Prostatic Diseases
Genital Neoplasms, Male
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Hormone Antagonists
Physiological Effects of Drugs
Estramustine
Hormones, Hormone Substitutes, and Hormone Antagonists
Urogenital Neoplasms
Flutamide
Etoposide phosphate
Hormones
Neoplasms by Site
Therapeutic Uses
Etoposide

Alkylating Agents
Antineoplastic Agents, Hormonal
Mitosis Modulators
Antimitotic Agents
Genital Diseases, Male
Pharmacologic Actions
Neoplasms
Androgen Antagonists
Paclitaxel
Tubulin Modulators
Bicalutamide
Antineoplastic Agents, Alkylating
Prostatic Neoplasms
Antineoplastic Agents, Phytogenic

ClinicalTrials.gov processed this record on November 22, 2009