Gabapentin in Treating Hot Flashes in Patients With Prostate Cancer
Overview[ - collapse ][ - ]
| Purpose | RATIONALE: Gabapentin may be effective in relieving hot flashes in men who have prostate cancer. It is not yet known which regimen of gabapentin is most effective in treating hot flashes. PURPOSE: Randomized phase III trial to compare different regimens of gabapentin in treating men who have prostate cancer. |
|---|---|
| Condition | Hot Flashes Prostate Cancer |
| Intervention | Drug: gabapentin |
| Phase | Phase 3 |
| Sponsor | Alliance for Clinical Trials in Oncology |
| Responsible Party | Alliance for Clinical Trials in Oncology |
| ClinicalTrials.gov Identifier | NCT00028574 |
| First Received | January 4, 2002 |
| Last Updated | September 26, 2013 |
| Last verified | September 2013 |
Tracking Information[ + expand ][ + ]
| First Received Date | January 4, 2002 |
|---|---|
| Last Updated Date | September 26, 2013 |
| Start Date | December 2001 |
| Estimated Primary Completion Date | April 2007 |
| Current Primary Outcome Measures | Hot flash reduction by diary scores at 4 weeks [Time Frame: 5 weeks from study entry] [Designated as safety issue: No] |
| Current Secondary Outcome Measures | Toxicity by questionnaires at 4 weeks [Time Frame: 5 weeks from study entry] [Designated as safety issue: Yes] |
Descriptive Information[ + expand ][ + ]
| Brief Title | Gabapentin in Treating Hot Flashes in Patients With Prostate Cancer |
|---|---|
| Official Title | A Phase III Randomized, Double-Blind, Placebo-Controlled Trial of Gabapentin in the Management of Hot Flashes in Men |
| Brief Summary | RATIONALE: Gabapentin may be effective in relieving hot flashes in men who have prostate cancer. It is not yet known which regimen of gabapentin is most effective in treating hot flashes. PURPOSE: Randomized phase III trial to compare different regimens of gabapentin in treating men who have prostate cancer. |
| Detailed Description | OBJECTIVES: - Determine the effectiveness of gabapentin in managing hot flashes in men with prostate cancer. - Determine the response of patients to this drug. - Determine the toxicity of this drug in these patients. - Determine the quality of life of patients treated with this drug. OUTLINE: This is a randomized, double-blind, placebo-controlled, multicenter study. Patients are stratified according to the number of hot flashes per day (2-3 vs 4-9 vs 10 or more) and duration of hot flash symptoms (less than 9 months vs 9 months or more). Patients are randomized to one of four treatment arms. All patients are observed for 7 days prior to drug administration in order to collect baseline hot flash information. - Arm I: Patients receive oral gabapentin once daily on days 1-28. - Arm II: Patients receive oral gabapentin once daily on days 1-7 and twice daily on days 8-28. - Arm III: Patients receive oral gabapentin once daily on days 1-7, twice daily on days 8-14, and three times daily on days 15-28. - Arm IV: Patients receive oral placebo on one of three schedules corresponding to arms I-III. Patients in all arms may continue therapy with gabapentin for an additional 8 weeks. Quality of life is assessed at baseline, day 28, and at the end of the additional 8 weeks. Patients are followed at 6, 12, and 24 months. PROJECTED ACCRUAL: A total of 220 patients (55 per treatment arm) will be accrued for this study within 1 year. |
| Study Type | Interventional |
| Study Phase | Phase 3 |
| Study Design | Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Supportive Care |
| Condition |
|
| Intervention | Drug: gabapentin |
| Study Arm (s) |
|
Recruitment Information[ + expand ][ + ]
| Recruitment Status | Completed |
|---|---|
| Estimated Enrollment | 223 |
| Estimated Completion Date | April 2007 |
| Estimated Primary Completion Date | December 2006 |
| Eligibility Criteria | DISEASE CHARACTERISTICS: - Diagnosis of prostate cancer - Received or are currently receiving androgen ablation therapy - Hot flashes for at least 1 month - At least 14 times per week and severe enough to require therapeutic intervention PATIENT CHARACTERISTICS: Age: - 18 and over Performance status: - ECOG 0-1 Life expectancy: - At least 6 months Hematopoietic: - Not specified Hepatic: - Not specified Renal: - Creatinine < 1.5 times upper limit of normal over the past 2 years Other: - No prior allergic or adverse reaction to gabapentin PRIOR CONCURRENT THERAPY: Biologic therapy: - Not specified Chemotherapy: - At least 4 weeks since prior antineoplastic chemotherapy - No concurrent antineoplastic chemotherapy Endocrine therapy: - See Disease Characteristics - At least 4 weeks since prior androgens, estrogens, or progestational agents - No concurrent androgens, estrogens, or progestational agents - Concurrent hormonal therapy allowed if on stable dose for at least 4 weeks and plan to continue therapy throughout study Radiotherapy: - Not specified Surgery: - Not specified Other: - No prior gabapentin - No other concurrent treatment for hot flashes - Concurrent antidepressants allowed if on stable dose for at least 1 month and plan to continue therapy throughout study |
| Gender | Male |
| Ages | 18 Years |
| Accepts Healthy Volunteers | No |
| Contacts | Not Provided |
| Location Countries | United States |
Administrative Information[ + expand ][ + ]
| NCT Number | NCT00028574 |
|---|---|
| Other Study ID Numbers | CDR0000069107 |
| Has Data Monitoring Committee | Yes |
| Information Provided By | Alliance for Clinical Trials in Oncology |
| Study Sponsor | Alliance for Clinical Trials in Oncology |
| Collaborators | National Cancer Institute (NCI) |
| Investigators | Study Chair: Charles L. Loprinzi, MD Mayo Clinic |
| Verification Date | September 2013 |
Locations[ + expand ][ + ]
| Mobile Infirmary Medical Center | Mobile, Alabama, United States, 36652-2144 |
|---|---|
| Howard University Cancer Center at Howard University Hospital | Washington, District of Columbia, United States, 20060 |
| Mayo Clinic - Jacksonville | Jacksonville, Florida, United States, 32224 |
| Kapiolani Medical Center at Pali Momi | Aiea, Hawaii, United States, 96701 |
| Leeward Radiation Oncology Center | Ewa Beach, Hawaii, United States, 96706 |
| Cancer Research Center of Hawaii | Honolula, Hawaii, United States, 96813 |
| OnCare Hawaii, Incorporated - Lusitana | Honolulu, Hawaii, United States, 96813 |
| Kapiolani Medical Center for Women and Children | Honolulu, Hawaii, United States, 96826 |
| OnCare Hawaii, Incorporated - Kuakini | Honolulu, Hawaii, United States, 96817 |
| Queen's Cancer Institute at Queen's Medical Center | Honolulu, Hawaii, United States, 96813 |
| St. Francis Medical Center | Honolulu, Hawaii, United States, 96817 |
| Straub Clinic and Hospital, Incorporated | Honolulu, Hawaii, United States, 96813 |
| Rush-Copley Cancer Care Center | Aurora, Illinois, United States, 60507 |
| St. Joseph Medical Center | Bloomington, Illinois, United States, 61701 |
| Graham Hospital | Canton, Illinois, United States, 61520 |
| Memorial Hospital | Carthage, Illinois, United States, 62321 |
| St. Anthony's Memorial Hospital | Effingham, Illinois, United States, 62401 |
| Eureka Community Hospital | Eureka, Illinois, United States, 61530 |
| Galesburg Cottage Hospital | Galesburg, Illinois, United States, 61401 |
| Galesburg Clinic | Galesburg, Illinois, United States, 61401 |
| Mason District Hospital | Havana, Illinois, United States, 62644 |
| Hopedale Medical Complex | Hopedale, Illinois, United States, 61747 |
| Joliet Oncology-Hematology Associates, Limited - West | Joliet, Illinois, United States, 60435 |
| Kewanee Hospital | Kewanee, Illinois, United States, 61443 |
| McDonough District Hospital | Macomb, Illinois, United States, 61455 |
| Trinity Medical Center - East | Moline, Illinois, United States, 61265 |
| United States, Illinois | Moline, Illinois, United States, 61265 |
| Community Cancer Center | Normal, Illinois, United States, 61761 |
| BroMenn Regional Medical Center | Normal, Illinois, United States, 61761 |
| Oncology Hematology Associates of Central Illinois, PC - Ottawa | Ottawa, Illinois, United States, 61350 |
| Community Hospital of Ottawa | Ottawa, Illinois, United States, 61350 |
| Cancer Treatment Center at Pekin Hospital | Pekin, Illinois, United States, 61554 |
| CCOP - Illinois Oncology Research Association | Peoria, Illinois, United States, 61615 |
| Methodist Medical Center of Illinois | Peoria, Illinois, United States, 61636 |
| Oncology Hematology Associates of Central Illinois, PC - Peoria | Peoria, Illinois, United States, 61615 |
| OSF St. Francis Medical Center | Peoria, Illinois, United States, 61637 |
| Proctor Hospital | Peoria, Illinois, United States, 61614 |
| Illinois Valley Community Hospital | Peru, Illinois, United States, 61354 |
| Perry Memorial Hospital | Princeton, Illinois, United States, 61356 |
| St. Margaret's Hospital | Spring Valley, Illinois, United States, 61362 |
| CCOP - Carle Cancer Center | Urbana, Illinois, United States, 61801 |
| Carle Cancer Center at Carle Foundation Hospital | Urbana, Illinois, United States, 61801 |
| Saint Anthony Memorial Health Centers | Michigan City, Indiana, United States, 46360 |
| McFarland Clinic, PC | Ames, Iowa, United States, 50010 |
| United States, Iowa | Bettendorf, Iowa, United States, 52722 |
| Cedar Rapids Oncology Associates | Cedar Rapids, Iowa, United States, 52403 |
| Mercy Regional Cancer Center at Mercy Medical Center | Cedar Rapids, Iowa, United States, 52403 |
| St. Luke's Hospital | Cedar Rapids, Iowa, United States, 52402 |
| CCOP - Iowa Oncology Research Association | Des Moines, Iowa, United States, 50309 |
| Mercy Cancer Center at Mercy Medical Center - Des Moines | Des Moines, Iowa, United States, 50314 |
| John Stoddard Cancer Center at Iowa Methodist Medical Center | Des Moines, Iowa, United States, 50309 |
| John Stoddard Cancer Center at Iowa Lutheran Hospital | Des Moines, Iowa, United States, 50316-2301 |
| Medical Oncology and Hematology Associates at John Stoddard Cancer Center | Des Moines, Iowa, United States, 50309 |
| Medical Oncology and Hematology Associates at Mercy Cancer Center | Des Moines, Iowa, United States, 50314 |
| Mercy Capitol Hospital | Des Moines, Iowa, United States, 50307 |
| Mercy Cancer Center at Mercy Medical Center - North Iowa | Mason City, Iowa, United States, 50401 |
| Ottumwa Regional Health Center Cancer Center | Ottumwa, Iowa, United States, 52501 |
| Mercy Medical Center - Sioux City | Sioux City, Iowa, United States, 51104 |
| Siouxland Hematology-Oncology Associates, LLP | Sioux City, Iowa, United States, 51101 |
| Siouxland Regional Cancer Center | Sioux City, Iowa, United States, 51101 |
| St. Luke's Regional Medical Center | Sioux City, Iowa, United States, 51104 |
| Medical Oncology and Hematology Associates - West Des Moines | West Des Moines, Iowa, United States, 50266 |
| Cancer Center of Kansas, PA - Chanute | Chanute, Kansas, United States, 66720 |
| Cancer Center of Kansas, PA - Dodge City | Dodge City, Kansas, United States, 67801 |
| Cancer Center of Kansas, PA - El Dorado | El Dorado, Kansas, United States, 67042 |
| Cancer Center of Kansas, PA - Kingman | Kingman, Kansas, United States, 67068 |
| Southwest Medical Center | Liberal, Kansas, United States, 67901 |
| Cancer Center of Kansas, PA - Newton | Newton, Kansas, United States, 67114 |
| Cancer Center of Kansas, PA - Parsons | Parsons, Kansas, United States, 67357 |
| Cancer Center of Kansas, PA - Pratt | Pratt, Kansas, United States, 67124 |
| Cancer Center of Kansas, PA - Salina | Salina, Kansas, United States, 67042 |
| Cancer Center of Kansas, PA - Wellington | Wellington, Kansas, United States, 67152 |
| Cancer Center of Kansas, PA - Medical Arts Tower | Wichita, Kansas, United States, 67208 |
| Associates in Womens Health, PA - North Review | Wichita, Kansas, United States, 67203 |
| Via Christi Cancer Center at Via Christi Regional Medical Center | Wichita, Kansas, United States, 67214 |
| CCOP - Wichita | Wichita, Kansas, United States, 67214 |
| Cancer Center of Kansas, PA - Wichita | Wichita, Kansas, United States, 67214 |
| Cancer Center of Kansas, PA - Winfield | Winfield, Kansas, United States, 67156 |
| Hickman Cancer Center at Bixby Medical Center | Adrian, Michigan, United States, 49221 |
| St. Joseph Mercy Cancer Center at St. Joseph Mercy Hospital | Ann Arbor, Michigan, United States, 48106-0995 |
| CCOP - Michigan Cancer Research Consortium | Ann Arbor, Michigan, United States, 48106 |
| Oakwood Cancer Center at Oakwood Hospital and Medical Center | Dearborn, Michigan, United States, 48123-2500 |
| Genesys Hurley Cancer Institute | Flint, Michigan, United States, 48503 |
| Hurley Medical Center | Flint, Michigan, United States, 48503 |
| Van Elslander Cancer Center at St. John Hospital and Medical Center | Grosse Pointe Woods, Michigan, United States, 48236 |
| Foote Hospital | Jackson, Michigan, United States, 49201 |
| Haematology-Oncology Associates of Ohio and Michigan, PC | Lambertville, Michigan, United States, 48144 |
| Sparrow Regional Cancer Center | Lansing, Michigan, United States, 48909 |
| Community Cancer Center of Monroe | Monroe, Michigan, United States, 48162 |
| Mercy Memorial Hospital System | Monroe, Michigan, United States, 48162 |
| Seton Cancer Institute - Saginaw | Saginaw, Michigan, United States, 48601 |
| St. John Macomb Hospital | Warren, Michigan, United States, 48093 |
| Albert Lea Cancer Center at Albert Lea Medical Center | Albert Lea, Minnesota, United States, 56007 |
| United States, Minnesota | Alexandria, Minnesota, United States, 56308 |
| St. Joseph's Medical Center | Brainerd, Minnesota, United States, 56401 |
| Brainerd Medical Center | Brainerd, Minnesota, United States, 56401 |
| CCOP - Duluth | Duluth, Minnesota, United States, 55805 |
| St. Mary's - Duluth Clinic Cancer Center | Duluth, Minnesota, United States, 55805 |
| Miller-Dwan Medical Center | Duluth, Minnesota, United States, 55805 |
| United States, Minnesota | Fergus Falls, Minnesota, United States, 56537 |
| Chippewa County - Montevideo Hospital | Montevideo, Minnesota, United States, 56265 |
| Mayo Clinic Cancer Center | Rochester, Minnesota, United States, 55905 |
| Coborn Cancer Center | Saint Cloud, Minnesota, United States, 56303 |
| Adult and Pediatric Urology, P.L.L.P. | Sartell, Minnesota, United States, 56377 |
| CentraCare Clinic - River Campus | St. Cloud, Minnesota, United States, 56303 |
| Willmar Cancer Center at Rice Memorial Hospital | Willmar, Minnesota, United States, 56201 |
| Deaconess Billings Clinic - Downtown | Billings, Montana, United States, 59107-7000 |
| CCOP - Montana Cancer Consortium | Billings, Montana, United States, 59101 |
| St. Vincent Healthcare | Billings, Montana, United States, 59101 |
| Northern Rockies Radiation Oncology Center | Billings, Montana, United States, 59101 |
| Hematology-Oncology Centers of the Northern Rockies - Billings | Billings, Montana, United States, 59101 |
| Bozeman Deaconess Hospital | Bozeman, Montana, United States, 59715 |
| St. James Community Hospital | Butte, Montana, United States, 59701 |
| Great Falls Clinic | Great Falls, Montana, United States, 59405 |
| St. Peter's Hospital | Helena, Montana, United States, 59601 |
| Glacier Oncology, PLLC | Kalispell, Montana, United States, 59901 |
| Kalispell Medical Oncology | Kalispell, Montana, United States, 59901 |
| Kalispell Regional Medical Center | Kalispell, Montana, United States, 59901 |
| Montana Cancer Center at St. Patrick Hospital and Health Sciences Center | Missoula, Montana, United States, 59807 |
| Community Medical Center | Missoula, Montana, United States, 59801 |
| Montana Cancer Specialists at Montana Cancer Center | Missoula, Montana, United States, 59807-7877 |
| Clinic of Dr. Judy L. Schmidt | Missoula, Montana, United States, 59804 |
| Cancer Resource Center - Lincoln | Lincoln, Nebraska, United States, 68510 |
| Alegant Health Cancer Center at Bergan Mercy Medical Center | Omaha, Nebraska, United States, 68124 |
| CCOP - Missouri Valley Cancer Consortium | Omaha, Nebraska, United States, 68106 |
| Creighton University Medical Center | Omaha, Nebraska, United States, 68131-2197 |
| Immanuel Medical Center | Omaha, Nebraska, United States, 68122 |
| Rutherford Hospital | Rutherfordton, North Carolina, United States, 28139 |
| Bismarck Cancer Center | Bismarck, North Dakota, United States, 58501 |
| Cancer Care Center at Medcenter One Hospital | Bismarck, North Dakota, United States, 58501 |
| Mid Dakota Clinic, P. C. | Bismarck, North Dakota, United States, 58501 |
| St. Alexius Medical Center | Bismarck, North Dakota, United States, 58502 |
| Wood County Oncology Center | Bowling Green, Ohio, United States, 43402 |
| CCOP - Columbus | Columbus, Ohio, United States, 43215 |
| Mount Carmel Health - West Hospital | Columbus, Ohio, United States, 43222 |
| Riverside Methodist Hospital Cancer Care | Columbus, Ohio, United States, 43214-3998 |
| Doctors Hospital at Ohio Health | Columbus, Ohio, United States, 43228 |
| Grant Riverside Cancer Services | Columbus, Ohio, United States, 43215 |
| Grady Memorial Hospital | Delaware, Ohio, United States, 43015 |
| Blanchard Valley Medical Associates | Findlay, Ohio, United States, 45840 |
| Fremont Memorial Hospital | Fremont, Ohio, United States, 43420 |
| Kenton Oncology, Incorporated | Kenton, Ohio, United States, 43326 |
| Fairfield Medical Center | Lancaster, Ohio, United States, 43130 |
| Lima Memorial Hospital | Lima, Ohio, United States, 45804 |
| Strecker Cancer Center at Marietta Memorial Hospital | Marietta, Ohio, United States, 45750 |
| Northwest Ohio Oncology Center | Maumee, Ohio, United States, 43537 |
| St. Luke's Hospital | Maumee, Ohio, United States, 43537 |
| Licking Memorial Cancer Care Program at Licking Memorial Hospital | Newark, Ohio, United States, 43055 |
| Toledo Clinic - Oregon | Oregon, Ohio, United States, 43616 |
| St. Charles Mercy Hospital | Oregon, Ohio, United States, 43616 |
| Firelands Regional Medical Center | Sandusky, Ohio, United States, 44870 |
| North Coast Cancer Care, Incorporated | Sandusky, Ohio, United States, 44870 |
| Mercy Medical Center | Springfield, Ohio, United States, 45504 |
| Community Hospital of Springfield and Clark County | Springfield, Ohio, United States, 45505 |
| Flower Hospital Cancer Center | Sylvania, Ohio, United States, 43560 |
| Mercy Hospital of Tiffin | Tiffin, Ohio, United States, 44883 |
| Toledo Clinic, Incorporated - Main Clinic | Toledo, Ohio, United States, 43623 |
| Toledo Hospital | Toledo, Ohio, United States, 43606 |
| St. Vincent Mercy Medical Center | Toledo, Ohio, United States, 43608 |
| CCOP - Toledo Community Hospital | Toledo, Ohio, United States, 43617 |
| Medical University of Ohio Cancer Center | Toledo, Ohio, United States, 43614 |
| Fulton County Health Center | Wauseon, Ohio, United States, 43567 |
| Mount Carmel Cancer Services at Mount Carmel St. Ann's Hospital | Westerville, Ohio, United States, 43081 |
| Genesis - Good Samaritan Hospital | Zanesville, Ohio, United States, 43701 |
| Allegheny Cancer Center at Allegheny General Hospital | Pittsburgh, Pennsylvania, United States, 15212 |
| AnMed Health Cancer Center | Anderson, South Carolina, United States, 29621 |
| CCOP - Upstate Carolina | Spartanburg, South Carolina, United States, 29303 |
| Gibbs Regional Cancer Center at Spartanburg Regional Medical Center | Spartanburg, South Carolina, United States, 29303 |
| Rapid City Regional Hospital | Rapid City, South Dakota, United States, 57701 |
| Welch Cancer Center at Sheridan Memorial Hospital | Sheridan, Wyoming, United States, 82801 |