Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| S0032 | Other Identifier | SWOG | |
| U10CA032102 | U.S. NIH Grant/Contract | View source |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Androgens can stimulate the growth of prostate cancer cells. Drugs such as goserelin, leuprolide, flutamide, or bicalutamide may stop the adrenal glands from producing androgens. Combining chemotherapy with hormone therapy may kill more tumor cells.
PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy plus hormone therapy in treating patients who have metastatic prostate cancer.
OBJECTIVES:
OUTLINE: This is a multicenter study.
Patients are followed every 3 months until disease progression, every 6 months for 2 years, and then annually for 3 years.
PROJECTED ACCRUAL: A total of 80 patients will be accrued for this study within 2 years.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Hormone therapy, estramustine, etoposide and paclitaxel | Experimental | Hormone therapy (leuprolide, bicalutamide, nilutamide, goserelin, flutamide), estramustine, etoposide and paclitaxel |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| bicalutamide | Drug |
| ||
| estramustine |
| Measure | Description | Time Frame |
|---|---|---|
| Progression-free Survival | Measured from time of registration to time of first documentation of progression determined from the prostate-specific antigen (PSA) level, clinical criteria, or symptomatic deterioration. PSA progression is defined as a 25% increase greater than baseline. If the patient's PSA level had decrease during the study, a 25% increase from the nadir PSA level, with absolute value of >=5 ng/mL is considered progression. CLinical progress is defined as the appearance of any new lesion at any site or death without documented progression. Symptomatic deterioration is defined as a global deterioration of the health status requiring discontinuation of treatment without objective evidence of progression. | 0-5 years (assessed every 3 months if no progression when the chemotherapy had been finished. Once off chemotherapy, assessed every 3 months until progression) |
| Overall Survival (OS) | Overall survival is defined from the date of registration to date of death from any cause | 0-5 years |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Adverse Events (AEs) are reported by the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 2.0. For each patient, worst grade of each event type is reported. Grade 3 = Severe, Grade 4 = Life-threatening, Grade 5 = Fatal. | up to 5 years after registration |
Not provided
DISEASE CHARACTERISTICS:
Histologically or cytologically confirmed high-risk adenocarcinoma of the prostate
Clinical stage D2 disease as evidenced by one of the following:
No prior or concurrent (treated or untreated) brain metastases
No evidence of untreated spinal cord compression
PATIENT CHARACTERISTICS:
Age:
Performance status:
Life expectancy:
Hematopoietic:
Hepatic:
Renal:
Cardiovascular:
Pulmonary:
Other:
PRIOR CONCURRENT THERAPY:
Biologic therapy:
Chemotherapy:
Endocrine therapy:
Radiotherapy:
Surgery:
Other:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| David C. Smith, MD | University of Michigan Rogel Cancer Center | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| MBCCOP - Gulf Coast | Mobile | Alabama | 36607 | United States | ||
| CCOP - Western Regional, Arizona |
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | CAD + Chemo | Patients receive Combined androgen deprivation (CAD) therapy with LHRH agonist (goserelin acetate or leuprolide acetate) sq/IM q 1-4 months depending on dose chosen by the treating physician and oral antiandrogen (250 mg/tid of flutamide, 50 mg/d of bicalutamide or 300 mg/d for 30 days then 150 mg/d of nilutamide) given continuously until disease progression and Chemotherapy (4 cycles of estramustine 280 mg orally 3 times daily and etoposide 50 mg/m^2 daily for 14 days of each 21-day cycle, with paclitaxel 135 mg/m^2 given intravenously within 1 hour on day 2 of each cycle) |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Drug |
|
|
| etoposide | Drug |
|
| flutamide | Drug |
|
| goserelin | Drug |
|
| leuprolide | Drug |
|
|
| nilutamide | Drug |
|
| paclitaxel | Drug |
|
| Phoenix |
| Arizona |
| 85006-2726 |
| United States |
| Veterans Affairs Medical Center - Phoenix (Carl T. Hayden) | Phoenix | Arizona | 85012 | United States |
| Veterans Affairs Medical Center - Tucson | Tucson | Arizona | 85723 | United States |
| Arizona Cancer Center at University of Arizona Health Sciences Center | Tucson | Arizona | 85724 | United States |
| Arkansas Cancer Research Center at University of Arkansas for Medical Sciences | Little Rock | Arkansas | 72205 | United States |
| Veterans Affairs Medical Center - Little Rock | Little Rock | Arkansas | 72205 | United States |
| City of Hope Comprehensive Cancer Center | Duarte | California | 91010-3000 | United States |
| USC/Norris Comprehensive Cancer Center and Hospital | Los Angeles | California | 90033 | United States |
| Veterans Affairs Medical Center - West Los Angeles | Los Angeles | California | 90073 | United States |
| Veterans Affairs Outpatient Clinic - Martinez | Martinez | California | 94553 | United States |
| CCOP - Bay Area Tumor Institute | Oakland | California | 94609-3305 | United States |
| Chao Family Comprehensive Cancer Center at University of California Irvine Medical Center | Orange | California | 92868 | United States |
| University of California Davis Cancer Center | Sacramento | California | 95817 | United States |
| CCOP - Santa Rosa Memorial Hospital | Santa Rosa | California | 95403 | United States |
| University of Colorado Cancer Center at University of Colorado Health Sciences Center | Aurora | Colorado | 80010 | United States |
| Veterans Affairs Medical Center - Denver | Denver | Colorado | 80220 | United States |
| MBCCOP - Howard University Cancer Center | Washington D.C. | District of Columbia | 20060 | United States |
| Veterans Affairs Medical Center - Tampa (Haley) | Tampa | Florida | 33612 | United States |
| CCOP - Atlanta Regional | Atlanta | Georgia | 30342-1701 | United States |
| MBCCOP - Hawaii | Honolulu | Hawaii | 96813 | United States |
| MBCCOP - University of Illinois at Chicago | Chicago | Illinois | 60612 | United States |
| Veterans Affairs Medical Center - Chicago Westside Hospital | Chicago | Illinois | 60612 | United States |
| CCOP - Central Illinois | Decatur | Illinois | 62526 | United States |
| Veterans Affairs Medical Center - Hines | Hines | Illinois | 60141 | United States |
| Cardinal Bernardin Cancer Center at Loyola University Medical Center | Maywood | Illinois | 60153-5500 | United States |
| Kansas Masonic Cancer Research Institute at the University of Kansas Medical Center | Kansas City | Kansas | 66160-7390 | United States |
| CCOP - Wichita | Wichita | Kansas | 67214-3882 | United States |
| Veterans Affairs Medical Center - Wichita | Wichita | Kansas | 67218 | United States |
| Veterans Affairs Medical Center - Lexington | Lexington | Kentucky | 40502-2236 | United States |
| Markey Cancer Center at University of Kentucky Chandler Medical Center | Lexington | Kentucky | 40536-0084 | United States |
| MBCCOP - LSU Health Sciences Center | New Orleans | Louisiana | 70112 | United States |
| Tulane Cancer Center at Tulane University Hospital and Clinic | New Orleans | Louisiana | 70112 | 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 |
| Feist-Weiller Cancer Center at Louisiana State University Health Sciences | Shreveport | Louisiana | 71130-3932 | United States |
| Cancer Research Center at Boston Medical Center | Boston | Massachusetts | 02118 | United States |
| CCOP - Michigan Cancer Research Consortium | Ann Arbor | Michigan | 48106 | United States |
| University of Michigan Comprehensive Cancer Center | Ann Arbor | Michigan | 48109-0946 | United States |
| Barbara Ann Karmanos Cancer Institute | Detroit | Michigan | 48201-1379 | United States |
| Veterans Affairs Medical Center - Detroit | Detroit | Michigan | 48201-1932 | United States |
| Josephine Ford Cancer Center at Henry Ford Health System | Detroit | Michigan | 48202 | United States |
| CCOP - Grand Rapids | Grand Rapids | Michigan | 49503 | United States |
| CCOP - Beaumont | Royal Oak | Michigan | 48073-6769 | United States |
| Providence Cancer Institute at Providence Hospital - Southfield Campus | Southfield | Michigan | 48075 | United States |
| University of Mississippi Medical Center | Jackson | Mississippi | 39216-4505 | United States |
| Veterans Affairs Medical Center - Jackson | Jackson | Mississippi | 39216 | United States |
| CCOP - Kansas City | Kansas City | Missouri | 64131 | United States |
| CCOP - Cancer Research for the Ozarks | Springfield | Missouri | 65807 | United States |
| Saint Louis University Cancer Center | St Louis | Missouri | 63110 | United States |
| CCOP - St. Louis-Cape Girardeau | St Louis | Missouri | 63141 | United States |
| CCOP - Montana Cancer Consortium | Billings | Montana | 59101 | United States |
| Veterans Affairs Medical Center - Albuquerque | Albuquerque | New Mexico | 87108-5138 | United States |
| MBCCOP - University of New Mexico HSC | Albuquerque | New Mexico | 87131 | United States |
| Western New York Urology Associates | Cheektowaga | New York | 14225 | United States |
| NYU Cancer Institute at New York University Medical Center | New York | New York | 10016 | United States |
| Herbert Irving Comprehensive Cancer Center at Columbia University | New York | New York | 10032 | United States |
| James P. Wilmot Cancer Center at University of Rochester Medical Center | Rochester | New York | 14642 | United States |
| CCOP - Southeast Cancer Control Consortium | Goldsboro | North Carolina | 27534-9479 | United States |
| Veterans Affairs Medical Center - Cincinnati | Cincinnati | Ohio | 45220-2288 | United States |
| Charles M. Barrett Cancer Center at University Hospital | Cincinnati | Ohio | 45267-0501 | United States |
| Cleveland Clinic Taussig Cancer Center | Cleveland | Ohio | 44195-9001 | United States |
| CCOP - Columbus | Columbus | Ohio | 43206 | United States |
| Veterans Affairs Medical Center - Dayton | Dayton | Ohio | 45428-1002 | United States |
| CCOP - Dayton | Dayton | Ohio | 45429 | United States |
| Oklahoma University Medical Center | Oklahoma City | Oklahoma | 73104 | United States |
| Cancer Institute at Oregon Health and Science University | Portland | Oregon | 97201-3098 | United States |
| CCOP - Columbia River Oncology Program | Portland | Oregon | 97225 | United States |
| Veterans Affairs Medical Center - Charleston | Charleston | South Carolina | 29401-5799 | United States |
| Hollings Cancer Center at Medical University of South Carolina | Charleston | South Carolina | 29425 | United States |
| CCOP - Greenville | Greenville | South Carolina | 29615 | United States |
| CCOP - Upstate Carolina | Spartanburg | South Carolina | 29303 | United States |
| University of Tennessee Cancer Institute at Methodist Central Hospital | Memphis | Tennessee | 38104 | United States |
| Harrington Cancer Center | Amarillo | Texas | 79106 | United States |
| Texas Tech University Health Sciences Center School of Medicine | Amarillo | Texas | 79106 | United States |
| Veterans Affairs Medical Center - Amarillo | Amarillo | Texas | 79106 | United States |
| Brooke Army Medical Center | Fort Sam Houston | Texas | 78234-6200 | United States |
| University of Texas Medical Branch | Galveston | Texas | 77555-0565 | United States |
| M.D. Anderson Cancer Center at University of Texas | Houston | Texas | 77030-4095 | United States |
| Baylor College of Medicine | Houston | Texas | 77030 | United States |
| UMC Southwest Cancer and Research Center | Lubbock | Texas | 79415-3364 | United States |
| University of Texas Health Science Center at San Antonio | San Antonio | Texas | 78229-3900 | United States |
| Veterans Affairs Medical Center - Temple | Temple | Texas | 76504 | United States |
| CCOP - Scott and White Hospital | Temple | Texas | 76508 | United States |
| Huntsman Cancer Institute at University of Utah | Salt Lake City | Utah | 84132 | United States |
| Veterans Affairs Medical Center - Salt Lake City | Salt Lake City | Utah | 84148 | United States |
| Sentara Cancer Institute at Sentara Norfolk General Hospital | Norfolk | Virginia | 23510-1115 | United States |
| CCOP - Virginia Mason Research Center | Seattle | Washington | 98101 | United States |
| Veterans Affairs Medical Center - Seattle | Seattle | Washington | 98108 | United States |
| Puget Sound Oncology Consortium | Seattle | Washington | 98109 | United States |
| CCOP - Northwest | Tacoma | Washington | 98405-0986 | United States |
| Eligible |
|
| Eligible and Began Protocol Therapy |
|
| COMPLETED |
|
| NOT COMPLETED |
|
|
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | CAD + Chemo | Patients receive Combined androgen deprivation (CAD) therapy with LHRH agonist (goserelin acetate or leuprolide acetate) sq/IM q 1-4 months depending on dose chosen by the treating physician and oral antiandrogen (250 mg/tid of flutamide, 50 mg/d of bicalutamide or 300 mg/d for 30 days then 150 mg/d of nilutamide) given continuously until disease progression and Chemotherapy (4 cycles of estramustine 280 mg orally 3 times daily and etoposide 50 mg/m^2 daily for 14 days of each 21-day cycle, with paclitaxel 135 mg/m^2 given intravenously within 1 hour on day 2 of each cycle) |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | |||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age Continuous | Median | Full Range | years |
| ||||||||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| |||||||||||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| |||||||||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
| |||||||||||||||||||||||
| Southwestern Oncology Group Performance Status | Patients will be graded according to the Zubrod performance status scale. 0: Fully active, able to carry all pre-disease performance without restriction. 1: Restricted in physically strenuous activity but ambulatory and able to carry out work of a light or sedentary nature. 2: Ambulatory and capable of self-care but unable to carry out any work activities; up and about more than 50% of waking hours. 3: Capable of limited self-care, confined to bed or chair more than 50% of waking hours. 4: Completely disabled; cannot carry on any self-care; totally confined to bed or chair. | Number | participants |
| ||||||||||||||||||||||
| Bone Pain Grade (CTC version 2.0) | 0 - none, 1 - mild pain not interfering with function, 2 - moderate pain: pain or analgesics interfering with function, but not interfering with activities of daily living, 3 - severe pain: pain or analgesics severely interfering with activities of daily living, 4 - disabling | Number | participants |
| ||||||||||||||||||||||
| Previous Prostatectomy | Number | participants |
| |||||||||||||||||||||||
| Gleason Score | Number | participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Progression-free Survival | Measured from time of registration to time of first documentation of progression determined from the prostate-specific antigen (PSA) level, clinical criteria, or symptomatic deterioration. PSA progression is defined as a 25% increase greater than baseline. If the patient's PSA level had decrease during the study, a 25% increase from the nadir PSA level, with absolute value of >=5 ng/mL is considered progression. CLinical progress is defined as the appearance of any new lesion at any site or death without documented progression. Symptomatic deterioration is defined as a global deterioration of the health status requiring discontinuation of treatment without objective evidence of progression. | All eligible patients who started treatment were included in the analysis | Posted | Median | 95% Confidence Interval | months | 0-5 years (assessed every 3 months if no progression when the chemotherapy had been finished. Once off chemotherapy, assessed every 3 months until progression) |
|
|
| |||||||||||||||||||||||||
| Secondary | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Adverse Events (AEs) are reported by the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 2.0. For each patient, worst grade of each event type is reported. Grade 3 = Severe, Grade 4 = Life-threatening, Grade 5 = Fatal. | Eligible patients who had received any treatment were included in the adverse event summaries. Any CTCAE 2.0 event of Grade 3 (severe), Grade 4 (life threatening), or Grade 5 (fatal) which deemed to be related to protocol treatment are included. | Posted | Number | Participants | up to 5 years after registration |
|
| |||||||||||||||||||||||||||
| Primary | Overall Survival (OS) | Overall survival is defined from the date of registration to date of death from any cause | All eligible patients who started treatment were included in the analysis | Posted | Median | 95% Confidence Interval | months | 0-5 years |
|
|
Patients were assessed for adverse events after every cycle (1 cycle = 21 days) of protocol treatment
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | CAD + Chemo | Patients receive Combined androgen deprivation (CAD) therapy with LHRH agonist (goserelin acetate or leuprolide acetate) sq/IM q 1-4 months depending on dose chosen by the treating physician and oral antiandrogen (250 mg/tid of flutamide, 50 mg/d of bicalutamide or 300 mg/d for 30 days then 150 mg/d of nilutamide) given continuously until disease progression and Chemotherapy (4 cycles of estramustine 280 mg orally 3 times daily and etoposide 50 mg/m^2 daily for 14 days of each 21-day cycle, with paclitaxel 135 mg/m^2 given intravenously within 1 hour on day 2 of each cycle) | 6 | 35 | 35 | 35 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Cardiac ischemia/infarction | Cardiac disorders | CTCAE (2.0) | Systematic Assessment |
| |
| Flu-like symptoms-other | General disorders | CTCAE (2.0) | Systematic Assessment |
| |
| Infection with 3-4 neutropenia | Infections and infestations | CTCAE (2.0) | Systematic Assessment |
| |
| Abnormal troponin I (cTnI) | Investigations | CTCAE (2.0) | Systematic Assessment |
| |
| Leukopenia | Investigations | CTCAE (2.0) | Systematic Assessment |
| |
| Second primary | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | CTCAE (2.0) | Systematic Assessment |
| |
| Thrombosis/embolism | Vascular disorders | CTCAE (2.0) | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anemia | Blood and lymphatic system disorders | CTCAE (2.0) | Systematic Assessment |
| |
| PRBC transfusion | Blood and lymphatic system disorders | CTCAE (2.0) | Systematic Assessment |
| |
| Abdominal pain/cramping | Gastrointestinal disorders | CTCAE (2.0) | Systematic Assessment |
| |
| Constipation/bowel obstruction | Gastrointestinal disorders | CTCAE (2.0) | Systematic Assessment |
| |
| Diarrhea without colostomy | Gastrointestinal disorders | CTCAE (2.0) | Systematic Assessment |
| |
| Dyspepsia/heartburn | Gastrointestinal disorders | CTCAE (2.0) | Systematic Assessment |
| |
| Esophagitis/dysphagia | Gastrointestinal disorders | CTCAE (2.0) | Systematic Assessment |
| |
| GI-other | Gastrointestinal disorders | CTCAE (2.0) | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | CTCAE (2.0) | Systematic Assessment |
| |
| Proctitis | Gastrointestinal disorders | CTCAE (2.0) | Systematic Assessment |
| |
| Stomatitis/pharyngitis | Gastrointestinal disorders | CTCAE (2.0) | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | CTCAE (2.0) | Systematic Assessment |
| |
| Edema | General disorders | CTCAE (2.0) | Systematic Assessment |
| |
| Fatigue/malaise/lethargy | General disorders | CTCAE (2.0) | Systematic Assessment |
| |
| Fever without neutropenia | General disorders | CTCAE (2.0) | Systematic Assessment |
| |
| Pain-other | General disorders | CTCAE (2.0) | Systematic Assessment |
| |
| Infection w/o 3-4 neutropenia | Infections and infestations | CTCAE (2.0) | Systematic Assessment |
| |
| Respiratory infect w/o neutrop | Infections and infestations | CTCAE (2.0) | Systematic Assessment |
| |
| Alkaline phosphatase increase | Investigations | CTCAE (2.0) | Systematic Assessment |
| |
| Bilirubin increase | Investigations | CTCAE (2.0) | Systematic Assessment |
| |
| Creatinine increase | Investigations | CTCAE (2.0) | Systematic Assessment |
| |
| Leukopenia | Investigations | CTCAE (2.0) | Systematic Assessment |
| |
| Lymphopenia | Investigations | CTCAE (2.0) | Systematic Assessment |
| |
| Neutropenia/granulocytopenia | Investigations | CTCAE (2.0) | Systematic Assessment |
| |
| SGOT (AST) increase | Investigations | CTCAE (2.0) | Systematic Assessment |
| |
| SGPT (ALT) increase | Investigations | CTCAE (2.0) | Systematic Assessment |
| |
| Thrombocytopenia | Investigations | CTCAE (2.0) | Systematic Assessment |
| |
| Weight gain | Investigations | CTCAE (2.0) | Systematic Assessment |
| |
| Weight loss | Investigations | CTCAE (2.0) | Systematic Assessment |
| |
| Anorexia | Metabolism and nutrition disorders | CTCAE (2.0) | Systematic Assessment |
| |
| Hyperglycemia | Metabolism and nutrition disorders | CTCAE (2.0) | Systematic Assessment |
| |
| Hyperkalemia | Metabolism and nutrition disorders | CTCAE (2.0) | Systematic Assessment |
| |
| Hypoalbuminemia | Metabolism and nutrition disorders | CTCAE (2.0) | Systematic Assessment |
| |
| Hypocalcemia | Metabolism and nutrition disorders | CTCAE (2.0) | Systematic Assessment |
| |
| Hypokalemia | Metabolism and nutrition disorders | CTCAE (2.0) | Systematic Assessment |
| |
| Hyponatremia | Metabolism and nutrition disorders | CTCAE (2.0) | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | CTCAE (2.0) | Systematic Assessment |
| |
| Bone pain | Musculoskeletal and connective tissue disorders | CTCAE (2.0) | Systematic Assessment |
| |
| Joint,muscle,bone-other | Musculoskeletal and connective tissue disorders | CTCAE (2.0) | Systematic Assessment |
| |
| Myalgia | Musculoskeletal and connective tissue disorders | CTCAE (2.0) | Systematic Assessment |
| |
| Myalgia/arthralgia, NOS | Musculoskeletal and connective tissue disorders | CTCAE (2.0) | Systematic Assessment |
| |
| Dizziness/light headedness | Nervous system disorders | CTCAE (2.0) | Systematic Assessment |
| |
| Headache | Nervous system disorders | CTCAE (2.0) | Systematic Assessment |
| |
| Sensory neuropathy | Nervous system disorders | CTCAE (2.0) | Systematic Assessment |
| |
| Weakness (motor neuropathy) | Nervous system disorders | CTCAE (2.0) | Systematic Assessment |
| |
| Confusion | Psychiatric disorders | CTCAE (2.0) | Systematic Assessment |
| |
| Depression | Psychiatric disorders | CTCAE (2.0) | Systematic Assessment |
| |
| Insomnia | Psychiatric disorders | CTCAE (2.0) | Systematic Assessment |
| |
| Dysuria | Renal and urinary disorders | CTCAE (2.0) | Systematic Assessment |
| |
| Hematuria | Renal and urinary disorders | CTCAE (2.0) | Systematic Assessment |
| |
| Incontinence | Renal and urinary disorders | CTCAE (2.0) | Systematic Assessment |
| |
| Urinary frequency/urgency | Renal and urinary disorders | CTCAE (2.0) | Systematic Assessment |
| |
| Urinary retention | Renal and urinary disorders | CTCAE (2.0) | Systematic Assessment |
| |
| Erectile impotence | Reproductive system and breast disorders | CTCAE (2.0) | Systematic Assessment |
| |
| Gynecomastia | Reproductive system and breast disorders | CTCAE (2.0) | Systematic Assessment |
| |
| Libido loss | Reproductive system and breast disorders | CTCAE (2.0) | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | CTCAE (2.0) | Systematic Assessment |
| |
| Dyspnea | Respiratory, thoracic and mediastinal disorders | CTCAE (2.0) | Systematic Assessment |
| |
| Hiccoughs | Respiratory, thoracic and mediastinal disorders | CTCAE (2.0) | Systematic Assessment |
| |
| Alopecia | Skin and subcutaneous tissue disorders | CTCAE (2.0) | Systematic Assessment |
| |
| Nail changes | Skin and subcutaneous tissue disorders | CTCAE (2.0) | Systematic Assessment |
| |
| Pruritus | Skin and subcutaneous tissue disorders | CTCAE (2.0) | Systematic Assessment |
| |
| Rash/desquamation | Skin and subcutaneous tissue disorders | CTCAE (2.0) | Systematic Assessment |
| |
| Skin-other | Skin and subcutaneous tissue disorders | CTCAE (2.0) | Systematic Assessment |
| |
| Hot flashes | Vascular disorders | CTCAE (2.0) | Systematic Assessment |
| |
| Hypertension | Vascular disorders | CTCAE (2.0) | Systematic Assessment |
| |
| Thrombosis/embolism | Vascular disorders | CTCAE (2.0) | Systematic Assessment |
|
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Study Statistician | SWOG Statistical Center | 206-667-4623 |
| ID | Term |
|---|---|
| D011471 | Prostatic Neoplasms |
| ID | Term |
|---|---|
| D005834 | Genital Neoplasms, Male |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D005832 | Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D011469 | Prostatic Diseases |
| D052801 | Male Urogenital Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| C053541 | bicalutamide |
| D004961 | Estramustine |
| D005047 | Etoposide |
| D005485 | Flutamide |
| D017273 | Goserelin |
| D016729 | Leuprolide |
| C021277 | nilutamide |
| D017239 | Paclitaxel |
| ID | Term |
|---|---|
| D009588 | Nitrogen Mustard Compounds |
| D009150 | Mustard Compounds |
| D006846 | Hydrocarbons, Halogenated |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D004958 | Estradiol |
| D004963 | Estrenes |
| D004962 | Estranes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D011034 | Podophyllotoxin |
| D013764 | Tetrahydronaphthalenes |
| D009281 | Naphthalenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D005960 | Glucosides |
| D006027 | Glycosides |
| D002241 | Carbohydrates |
| D000813 | Anilides |
| D000577 | Amides |
| D000814 | Aniline Compounds |
| D000588 | Amines |
| D007987 | Gonadotropin-Releasing Hormone |
| D010906 | Pituitary Hormone-Releasing Hormones |
| D007028 | Hypothalamic Hormones |
| D036361 | Peptide Hormones |
| D006728 | Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
| D009479 | Neuropeptides |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
| D009842 | Oligopeptides |
| D009419 | Nerve Tissue Proteins |
| D011506 | Proteins |
| D043823 | Taxoids |
| D043822 | Cyclodecanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
| D004224 | Diterpenes |
| D013729 | Terpenes |
Not provided
Not provided
| Unknown or Not Reported |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
| Title | Measurements |
|---|
|
| >=2 |
|
| 7 |
|
| 8 |
|
| 9-10 |
|
|
|