Gabapentin in Treating Hot Flashes in Patients With Prostate Cancer

Condition(s) targeted: Hot Flashes; Prostate Cancer

Intervention: gabapentin (Drug)

Phase: Phase 3

Status: Active, not recruiting

Sponsored by: North Central Cancer Treatment Group

Official(s) and/or principal investigator(s):
Charles L. Loprinzi, MD, Study Chair, Affiliation: Mayo Clinic
Debra Barton, RN, PhD, Affiliation: Mayo Clinic

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.

Official title: A Phase III Randomized, Double-Blind, Placebo-Controlled Trial of Gabapentin in the Management of Hot Flashes in Men

Study design: Supportive Care, Randomized, Double-Blind, Placebo Control

Primary outcome: Hot flash reduction by diary scores at 4 weeks

Secondary outcome: Toxicity by questionnaires at 4 weeks

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.

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Male.

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

Mobile Infirmary Medical Center, Mobile, Alabama 36652-2144, United States

Howard University Cancer Center at Howard University Hospital, Washington, District of Columbia 20060, United States

Mayo Clinic - Jacksonville, Jacksonville, Florida 32224, United States

Cancer Research Center of Hawaii, Honolula, Hawaii 96813, United States

Kapiolani Medical Center at Pali Momi, Aiea, Hawaii 96701, United States

Kapiolani Medical Center for Women and Children, Honolulu, Hawaii 96826, United States

Leeward Radiation Oncology Center, Ewa Beach, Hawaii 96706, United States

OnCare Hawaii, Incorporated - Kuakini, Honolulu, Hawaii 96817, United States

OnCare Hawaii, Incorporated - Lusitana, Honolulu, Hawaii 96813, United States

Queen's Cancer Institute at Queen's Medical Center, Honolulu, Hawaii 96813, United States

St. Francis Medical Center, Honolulu, Hawaii 96817, United States

Straub Clinic and Hospital, Incorporated, Honolulu, Hawaii 96813, United States

BroMenn Regional Medical Center, Normal, Illinois 61761, United States

Cancer Treatment Center at Pekin Hospital, Pekin, Illinois 61554, United States

Carle Cancer Center at Carle Foundation Hospital, Urbana, Illinois 61801, United States

CCOP - Carle Cancer Center, Urbana, Illinois 61801, United States

CCOP - Illinois Oncology Research Association, Peoria, Illinois 61615, United States

Community Cancer Center, Normal, Illinois 61761, United States

Community Hospital of Ottawa, Ottawa, Illinois 61350, United States

Moline, Illinois 61265, United States

Eureka Community Hospital, Eureka, Illinois 61530, United States

Galesburg Clinic, Galesburg, Illinois 61401, United States

Galesburg Cottage Hospital, Galesburg, Illinois 61401, United States

Graham Hospital, Canton, Illinois 61520, United States

Hopedale Medical Complex, Hopedale, Illinois 61747, United States

Illinois Valley Community Hospital, Peru, Illinois 61354, United States

Joliet Oncology-Hematology Associates, Limited - West, Joliet, Illinois 60435, United States

Kewanee Hospital, Kewanee, Illinois 61443, United States

Mason District Hospital, Havana, Illinois 62644, United States

McDonough District Hospital, Macomb, Illinois 61455, United States

Memorial Hospital, Carthage, Illinois 62321, United States

Methodist Medical Center of Illinois, Peoria, Illinois 61636, United States

Oncology Hematology Associates of Central Illinois, PC - Ottawa, Ottawa, Illinois 61350, United States

Oncology Hematology Associates of Central Illinois, PC - Peoria, Peoria, Illinois 61615, United States

OSF St. Francis Medical Center, Peoria, Illinois 61637, United States

Perry Memorial Hospital, Princeton, Illinois 61356, United States

Proctor Hospital, Peoria, Illinois 61614, United States

Rush-Copley Cancer Care Center, Aurora, Illinois 60507, United States

St. Anthony's Memorial Hospital, Effingham, Illinois 62401, United States

St. Joseph Medical Center, Bloomington, Illinois 61701, United States

St. Margaret's Hospital, Spring Valley, Illinois 61362, United States

Trinity Medical Center - East, Moline, Illinois 61265, United States

Saint Anthony Memorial Health Centers, Michigan City, Indiana 46360, United States

CCOP - Iowa Oncology Research Association, Des Moines, Iowa 50309, United States

Cedar Rapids Oncology Associates, Cedar Rapids, Iowa 52403, United States

Bettendorf, Iowa 52722, 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

McFarland Clinic, PC, Ames, Iowa 50010, United States

Medical Oncology and Hematology Associates - West Des Moines, West Des Moines, Iowa 50266, United States

Medical Oncology and Hematology Associates at John Stoddard Cancer Center, Des Moines, Iowa 50309, United States

Medical Oncology and Hematology Associates at Mercy Cancer Center, Des Moines, Iowa 50314, United States

Mercy Cancer Center at Mercy Medical Center - Des Moines, Des Moines, Iowa 50314, United States

Mercy Cancer Center at Mercy Medical Center - North Iowa, Mason City, Iowa 50401, United States

Mercy Capitol Hospital, Des Moines, Iowa 50307, United States

Mercy Medical Center - Sioux City, Sioux City, Iowa 51104, United States

Mercy Regional Cancer Center at Mercy Medical Center, Cedar Rapids, Iowa 52403, United States

Ottumwa Regional Health Center Cancer Center, Ottumwa, Iowa 52501, United States

Siouxland Hematology-Oncology Associates, LLP, Sioux City, Iowa 51101, United States

Siouxland Regional Cancer Center, Sioux City, Iowa 51101, United States

St. Luke's Hospital, Cedar Rapids, Iowa 52402, United States

St. Luke's Regional Medical Center, Sioux City, Iowa 51104, United States

Associates in Womens Health, PA - North Review, Wichita, Kansas 67203, United States

Cancer Center of Kansas, PA - Kingman, Kingman, Kansas 67068, United States

Cancer Center of Kansas, PA - Wichita, Wichita, Kansas 67214, United States

Cancer Center of Kansas, PA - Chanute, Chanute, Kansas 66720, United States

Cancer Center of Kansas, PA - Dodge City, Dodge City, Kansas 67801, United States

Cancer Center of Kansas, PA - El Dorado, El Dorado, Kansas 67042, United States

Cancer Center of Kansas, PA - Medical Arts Tower, Wichita, Kansas 67208, United States

Cancer Center of Kansas, PA - Newton, Newton, Kansas 67114, United States

Cancer Center of Kansas, PA - Parsons, Parsons, Kansas 67357, United States

Cancer Center of Kansas, PA - Pratt, Pratt, Kansas 67124, United States

Cancer Center of Kansas, PA - Salina, Salina, Kansas 67042, United States

Cancer Center of Kansas, PA - Wellington, Wellington, Kansas 67152, United States

Cancer Center of Kansas, PA - Winfield, Winfield, Kansas 67156, United States

CCOP - Wichita, Wichita, Kansas 67214, United States

Southwest Medical Center, Liberal, Kansas 67901, United States

Via Christi Cancer Center at Via Christi Regional Medical Center, Wichita, Kansas 67214, United States

CCOP - Michigan Cancer Research Consortium, Ann Arbor, Michigan 48106, United States

Community Cancer Center of Monroe, Monroe, Michigan 48162, United States

Foote Hospital, Jackson, Michigan 49201, United States

Genesys Hurley Cancer Institute, Flint, Michigan 48503, United States

Haematology-Oncology Associates of Ohio and Michigan, PC, Lambertville, Michigan 48144, United States

Hickman Cancer Center at Bixby Medical Center, Adrian, Michigan 49221, United States

Hurley Medical Center, Flint, Michigan 48503, United States

Mercy Memorial Hospital System, Monroe, Michigan 48162, United States

Oakwood Cancer Center at Oakwood Hospital and Medical Center, Dearborn, Michigan 48123-2500, United States

Seton Cancer Institute - Saginaw, Saginaw, Michigan 48601, United States

Sparrow Regional Cancer Center, Lansing, Michigan 48909, United States

St. John Macomb Hospital, Warren, Michigan 48093, United States

St. Joseph Mercy Cancer Center at St. Joseph Mercy Hospital, Ann Arbor, Michigan 48106-0995, United States

Van Elslander Cancer Center at St. John Hospital and Medical Center, Grosse Pointe Woods, Michigan 48236, United States

Adult and Pediatric Urology, P.L.L.P., Sartell, Minnesota 56377, United States

Albert Lea Cancer Center at Albert Lea Medical Center, Albert Lea, Minnesota 56007, United States

Brainerd Medical Center, Brainerd, Minnesota 56401, United States

CCOP - Duluth, Duluth, Minnesota 55805, United States

CentraCare Clinic - River Campus, St. Cloud, Minnesota 56303, United States

Chippewa County - Montevideo Hospital, Montevideo, Minnesota 56265, United States

Coborn Cancer Center, Saint Cloud, Minnesota 56303, United States

Mayo Clinic Cancer Center, Rochester, Minnesota 55905, United States

Miller-Dwan Medical Center, Duluth, Minnesota 55805, United States

St. Joseph's Medical Center, Brainerd, Minnesota 56401, United States

St. Mary's - Duluth Clinic Cancer Center, Duluth, Minnesota 55805, United States

Willmar Cancer Center at Rice Memorial Hospital, Willmar, Minnesota 56201, United States

Fergus Falls, Minnesota 56537, United States

Alexandria, Minnesota 56308, United States

Bozeman Deaconess Hospital, Bozeman, Montana 59715, United States

CCOP - Montana Cancer Consortium, Billings, Montana 59101, United States

Clinic of Dr. Judy L. Schmidt, Missoula, Montana 59804, United States

Community Medical Center, Missoula, Montana 59801, United States

Deaconess Billings Clinic - Downtown, Billings, Montana 59107-7000, United States

Glacier Oncology, PLLC, Kalispell, Montana 59901, United States

Great Falls Clinic, Great Falls, Montana 59405, United States

Hematology-Oncology Centers of the Northern Rockies - Billings, Billings, Montana 59101, United States

Kalispell Medical Oncology, Kalispell, Montana 59901, United States

Kalispell Regional Medical Center, Kalispell, Montana 59901, United States

Montana Cancer Center at St. Patrick Hospital and Health Sciences Center, Missoula, Montana 59807, United States

Montana Cancer Specialists at Montana Cancer Center, Missoula, Montana 59807-7877, United States

Northern Rockies Radiation Oncology Center, Billings, Montana 59101, United States

St. James Community Hospital, Butte, Montana 59701, United States

St. Peter's Hospital, Helena, Montana 59601, United States

St. Vincent Healthcare, Billings, Montana 59101, United States

Alegant Health Cancer Center at Bergan Mercy Medical Center, Omaha, Nebraska 68124, United States

Cancer Resource Center - Lincoln, Lincoln, Nebraska 68510, United States

CCOP - Missouri Valley Cancer Consortium, Omaha, Nebraska 68106, United States

Creighton University Medical Center, Omaha, Nebraska 68131-2197, United States

Immanuel Medical Center, Omaha, Nebraska 68122, United States

Rutherford Hospital, Rutherfordton, North Carolina 28139, United States

Bismarck Cancer Center, Bismarck, North Dakota 58501, United States

Cancer Care Center at Medcenter One Hospital, Bismarck, North Dakota 58501, United States

Mid Dakota Clinic, P. C., Bismarck, North Dakota 58501, United States

St. Alexius Medical Center, Bismarck, North Dakota 58502, United States

Blanchard Valley Medical Associates, Findlay, Ohio 45840, United States

CCOP - Columbus, Columbus, Ohio 43215, United States

CCOP - Toledo Community Hospital, Toledo, Ohio 43617, United States

Community Hospital of Springfield and Clark County, Springfield, Ohio 45505, United States

Doctors Hospital at Ohio Health, Columbus, Ohio 43228, United States

Fairfield Medical Center, Lancaster, Ohio 43130, United States

Firelands Regional Medical Center, Sandusky, Ohio 44870, United States

Flower Hospital Cancer Center, Sylvania, Ohio 43560, United States

Fremont Memorial Hospital, Fremont, Ohio 43420, United States

Fulton County Health Center, Wauseon, Ohio 43567, United States

Genesis - Good Samaritan Hospital, Zanesville, Ohio 43701, United States

Grady Memorial Hospital, Delaware, Ohio 43015, United States

Grant Riverside Cancer Services, Columbus, Ohio 43215, United States

Kenton Oncology, Incorporated, Kenton, Ohio 43326, United States

Licking Memorial Cancer Care Program at Licking Memorial Hospital, Newark, Ohio 43055, United States

Lima Memorial Hospital, Lima, Ohio 45804, United States

Medical University of Ohio Cancer Center, Toledo, Ohio 43614, United States

Mercy Hospital of Tiffin, Tiffin, Ohio 44883, United States

Mercy Medical Center, Springfield, Ohio 45504, United States

Mount Carmel Health - West Hospital, Columbus, Ohio 43222, United States

Mount Carmel Cancer Services at Mount Carmel St. Ann's Hospital, Westerville, Ohio 43081, United States

North Coast Cancer Care, Incorporated, Sandusky, Ohio 44870, United States

Northwest Ohio Oncology Center, Maumee, Ohio 43537, United States

Riverside Methodist Hospital Cancer Care, Columbus, Ohio 43214-3998, United States

St. Charles Mercy Hospital, Oregon, Ohio 43616, United States

St. Luke's Hospital, Maumee, Ohio 43537, United States

St. Vincent Mercy Medical Center, Toledo, Ohio 43608, United States

Strecker Cancer Center at Marietta Memorial Hospital, Marietta, Ohio 45750, United States

Toledo Clinic - Oregon, Oregon, Ohio 43616, United States

Toledo Clinic, Incorporated - Main Clinic, Toledo, Ohio 43623, United States

Toledo Hospital, Toledo, Ohio 43606, United States

Wood County Oncology Center, Bowling Green, Ohio 43402, United States

Allegheny Cancer Center at Allegheny General Hospital, Pittsburgh, Pennsylvania 15212, United States

AnMed Health Cancer Center, Anderson, South Carolina 29621, United States

CCOP - Upstate Carolina, Spartanburg, South Carolina 29303, United States

Gibbs Regional Cancer Center at Spartanburg Regional Medical Center, Spartanburg, South Carolina 29303, United States

Rapid City Regional Hospital, Rapid City, South Dakota 57701, United States

Welch Cancer Center at Sheridan Memorial Hospital, Sheridan, Wyoming 82801, United States

Clinical trial summary from the National Cancer Institute's PDQ® database

Starting date: December 2001
Last updated: May 23, 2008