Gabapentin in Treating Hot Flashes in Patients With Prostate Cancer

Last updated: June 27, 2016
Sponsor: Alliance for Clinical Trials in Oncology
Overall Status: Completed

Phase

3

Condition

Prostate Cancer

Urologic Cancer

Prostate Cancer, Early, Recurrent

Treatment

N/A

Clinical Study ID

NCT00028574
NCCTG-N00CB
NCI-P01-0199
NCI-2012-02435
CDR0000069107
NCCTG-N00CB
  • Ages > 18
  • Male

Study 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.

Eligibility Criteria

Inclusion

Required characteristics:

  1. Men with a history of prostate cancer who have received or are receiving androgen ablation therapy.

  2. Must be on a stable dose of hormone therapy for the past 4 weeks and must not be planning on discontinuing hormone therapy throughout the duration of the randomized phase (5 weeks).

  3. Presence of hot flashes for ≥1 month prior to study entry.

  4. Bothersome hot flashes (defined by their occurrence ≥14 times per week and of sufficient severity to make the patient desire therapeutic intervention).

  5. Life expectancy ≥ 6 months.

  6. ECOG Performance Status (PS) 0 or 1.

  7. ≥18 years of age

Contraindications:

  1. History of renal insufficiency (defined as a creatinine ≥1.5 x UNL in the last two years).

  2. Any of the following current (≤ 4 weeks) or planned therapies:

  • Antineoplastic chemotherapy

  • Androgens

  • Estrogens

  • Progestational agents

  1. History of allergic or other adverse reaction to gabapentin.

  2. Prior use of gabapentin.

  3. Antidepressants (use is allowed if patient has been on a stable dose for ≥1 month and does not plan to modify this treatment during the next 5 weeks).

Study Design

Total Participants: 223
Study Start date:
December 01, 2001
Estimated Completion Date:
April 30, 2007

Study 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.

Connect with a study center

  • Mobile Infirmary Medical Center

    Mobile, Alabama 36652-2144
    United States

    Site Not Available

  • Howard University Cancer Center at Howard University Hospital

    Washington, District of Columbia 20060
    United States

    Site Not Available

  • Mayo Clinic - Jacksonville

    Jacksonville, Florida 32224
    United States

    Site Not Available

  • Kapiolani Medical Center at Pali Momi

    Aiea, Hawaii 96701
    United States

    Site Not Available

  • Leeward Radiation Oncology Center

    Ewa Beach, Hawaii 96706
    United States

    Site Not Available

  • Cancer Research Center of Hawaii

    Honolula, Hawaii 96813
    United States

    Site Not Available

  • Kapiolani Medical Center for Women and Children

    Honolulu, Hawaii 96826
    United States

    Site Not Available

  • OnCare Hawaii, Incorporated - Kuakini

    Honolulu, Hawaii 96817
    United States

    Site Not Available

  • OnCare Hawaii, Incorporated - Lusitana

    Honolulu, Hawaii 96813
    United States

    Site Not Available

  • Queen's Cancer Institute at Queen's Medical Center

    Honolulu, Hawaii 96813
    United States

    Site Not Available

  • St. Francis Medical Center

    Honolulu, Hawaii 96817
    United States

    Site Not Available

  • Straub Clinic and Hospital, Incorporated

    Honolulu, Hawaii 96813
    United States

    Site Not Available

  • Rush-Copley Cancer Care Center

    Aurora, Illinois 60507
    United States

    Site Not Available

  • St. Joseph Medical Center

    Bloomington, Illinois 61701
    United States

    Site Not Available

  • Graham Hospital

    Canton, Illinois 61520
    United States

    Site Not Available

  • Memorial Hospital

    Carthage, Illinois 62321
    United States

    Site Not Available

  • St. Anthony's Memorial Hospital

    Effingham, Illinois 62401
    United States

    Site Not Available

  • Eureka Community Hospital

    Eureka, Illinois 61530
    United States

    Site Not Available

  • Galesburg Clinic

    Galesburg, Illinois 61401
    United States

    Site Not Available

  • Galesburg Cottage Hospital

    Galesburg, Illinois 61401
    United States

    Site Not Available

  • Mason District Hospital

    Havana, Illinois 62644
    United States

    Site Not Available

  • Hopedale Medical Complex

    Hopedale, Illinois 61747
    United States

    Site Not Available

  • Joliet Oncology-Hematology Associates, Limited - West

    Joliet, Illinois 60435
    United States

    Site Not Available

  • Kewanee Hospital

    Kewanee, Illinois 61443
    United States

    Site Not Available

  • McDonough District Hospital

    Macomb, Illinois 61455
    United States

    Site Not Available

  • Trinity Medical Center - East

    Moline, Illinois 61265
    United States

    Site Not Available

  • Moline, Illinois 61265
    United States

    Site Not Available

  • BroMenn Regional Medical Center

    Normal, Illinois 61761
    United States

    Site Not Available

  • Community Cancer Center

    Normal, Illinois 61761
    United States

    Site Not Available

  • Community Hospital of Ottawa

    Ottawa, Illinois 61350
    United States

    Site Not Available

  • Oncology Hematology Associates of Central Illinois, PC - Ottawa

    Ottawa, Illinois 61350
    United States

    Site Not Available

  • Cancer Treatment Center at Pekin Hospital

    Pekin, Illinois 61554
    United States

    Site Not Available

  • CCOP - Illinois Oncology Research Association

    Peoria, Illinois 61615
    United States

    Site Not Available

  • Methodist Medical Center of Illinois

    Peoria, Illinois 61636
    United States

    Site Not Available

  • OSF St. Francis Medical Center

    Peoria, Illinois 61637
    United States

    Site Not Available

  • Oncology Hematology Associates of Central Illinois, PC - Peoria

    Peoria, Illinois 61615
    United States

    Site Not Available

  • Proctor Hospital

    Peoria, Illinois 61614
    United States

    Site Not Available

  • Illinois Valley Community Hospital

    Peru, Illinois 61354
    United States

    Site Not Available

  • Perry Memorial Hospital

    Princeton, Illinois 61356
    United States

    Site Not Available

  • St. Margaret's Hospital

    Spring Valley, Illinois 61362
    United States

    Site Not Available

  • CCOP - Carle Cancer Center

    Urbana, Illinois 61801
    United States

    Site Not Available

  • Carle Cancer Center at Carle Foundation Hospital

    Urbana, Illinois 61801
    United States

    Site Not Available

  • Saint Anthony Memorial Health Centers

    Michigan City, Indiana 46360
    United States

    Site Not Available

  • McFarland Clinic, PC

    Ames, Iowa 50010
    United States

    Site Not Available

  • Bettendorf, Iowa 52722
    United States

    Site Not Available

  • Cedar Rapids Oncology Associates

    Cedar Rapids, Iowa 52403
    United States

    Site Not Available

  • Mercy Regional Cancer Center at Mercy Medical Center

    Cedar Rapids, Iowa 52403
    United States

    Site Not Available

  • St. Luke's Hospital

    Cedar Rapids, Iowa 52402
    United States

    Site Not Available

  • CCOP - Iowa Oncology Research Association

    Des Moines, Iowa 50309
    United States

    Site Not Available

  • John Stoddard Cancer Center at Iowa Lutheran Hospital

    Des Moines, Iowa 50316-2301
    United States

    Site Not Available

  • John Stoddard Cancer Center at Iowa Methodist Medical Center

    Des Moines, Iowa 50309
    United States

    Site Not Available

  • Medical Oncology and Hematology Associates at John Stoddard Cancer Center

    Des Moines, Iowa 50309
    United States

    Site Not Available

  • Medical Oncology and Hematology Associates at Mercy Cancer Center

    Des Moines, Iowa 50314
    United States

    Site Not Available

  • Mercy Cancer Center at Mercy Medical Center - Des Moines

    Des Moines, Iowa 50314
    United States

    Site Not Available

  • Mercy Capitol Hospital

    Des Moines, Iowa 50307
    United States

    Site Not Available

  • Mercy Cancer Center at Mercy Medical Center - North Iowa

    Mason City, Iowa 50401
    United States

    Site Not Available

  • Ottumwa Regional Health Center Cancer Center

    Ottumwa, Iowa 52501
    United States

    Site Not Available

  • Mercy Medical Center - Sioux City

    Sioux City, Iowa 51104
    United States

    Site Not Available

  • Siouxland Hematology-Oncology Associates, LLP

    Sioux City, Iowa 51101
    United States

    Site Not Available

  • Siouxland Regional Cancer Center

    Sioux City, Iowa 51101
    United States

    Site Not Available

  • St. Luke's Regional Medical Center

    Sioux City, Iowa 51104
    United States

    Site Not Available

  • Medical Oncology and Hematology Associates - West Des Moines

    West Des Moines, Iowa 50266
    United States

    Site Not Available

  • Cancer Center of Kansas, PA - Chanute

    Chanute, Kansas 66720
    United States

    Site Not Available

  • Cancer Center of Kansas, PA - Dodge City

    Dodge City, Kansas 67801
    United States

    Site Not Available

  • Cancer Center of Kansas, PA - El Dorado

    El Dorado, Kansas 67042
    United States

    Site Not Available

  • Cancer Center of Kansas, PA - Kingman

    Kingman, Kansas 67068
    United States

    Site Not Available

  • Southwest Medical Center

    Liberal, Kansas 67901
    United States

    Site Not Available

  • Cancer Center of Kansas, PA - Newton

    Newton, Kansas 67114
    United States

    Site Not Available

  • Cancer Center of Kansas, PA - Parsons

    Parsons, Kansas 67357
    United States

    Site Not Available

  • Cancer Center of Kansas, PA - Pratt

    Pratt, Kansas 67124
    United States

    Site Not Available

  • Cancer Center of Kansas, PA - Salina

    Salina, Kansas 67042
    United States

    Site Not Available

  • Cancer Center of Kansas, PA - Wellington

    Wellington, Kansas 67152
    United States

    Site Not Available

  • Associates in Womens Health, PA - North Review

    Wichita, Kansas 67203
    United States

    Site Not Available

  • CCOP - Wichita

    Wichita, Kansas 67214
    United States

    Site Not Available

  • Cancer Center of Kansas, PA - Medical Arts Tower

    Wichita, Kansas 67208
    United States

    Site Not Available

  • Cancer Center of Kansas, PA - Wichita

    Wichita, Kansas 67214
    United States

    Site Not Available

  • Via Christi Cancer Center at Via Christi Regional Medical Center

    Wichita, Kansas 67214
    United States

    Site Not Available

  • Cancer Center of Kansas, PA - Winfield

    Winfield, Kansas 67156
    United States

    Site Not Available

  • Hickman Cancer Center at Bixby Medical Center

    Adrian, Michigan 49221
    United States

    Site Not Available

  • CCOP - Michigan Cancer Research Consortium

    Ann Arbor, Michigan 48106
    United States

    Site Not Available

  • St. Joseph Mercy Cancer Center at St. Joseph Mercy Hospital

    Ann Arbor, Michigan 48106-0995
    United States

    Site Not Available

  • Oakwood Cancer Center at Oakwood Hospital and Medical Center

    Dearborn, Michigan 48123-2500
    United States

    Site Not Available

  • Genesys Hurley Cancer Institute

    Flint, Michigan 48503
    United States

    Site Not Available

  • Hurley Medical Center

    Flint, Michigan 48503
    United States

    Site Not Available

  • Van Elslander Cancer Center at St. John Hospital and Medical Center

    Grosse Pointe Woods, Michigan 48236
    United States

    Site Not Available

  • Foote Hospital

    Jackson, Michigan 49201
    United States

    Site Not Available

  • Haematology-Oncology Associates of Ohio and Michigan, PC

    Lambertville, Michigan 48144
    United States

    Site Not Available

  • Sparrow Regional Cancer Center

    Lansing, Michigan 48909
    United States

    Site Not Available

  • Community Cancer Center of Monroe

    Monroe, Michigan 48162
    United States

    Site Not Available

  • Mercy Memorial Hospital System

    Monroe, Michigan 48162
    United States

    Site Not Available

  • Seton Cancer Institute - Saginaw

    Saginaw, Michigan 48601
    United States

    Site Not Available

  • St. John Macomb Hospital

    Warren, Michigan 48093
    United States

    Site Not Available

  • Albert Lea Cancer Center at Albert Lea Medical Center

    Albert Lea, Minnesota 56007
    United States

    Site Not Available

  • Alexandria, Minnesota 56308
    United States

    Site Not Available

  • Brainerd Medical Center

    Brainerd, Minnesota 56401
    United States

    Site Not Available

  • St. Joseph's Medical Center

    Brainerd, Minnesota 56401
    United States

    Site Not Available

  • CCOP - Duluth

    Duluth, Minnesota 55805
    United States

    Site Not Available

  • Miller-Dwan Medical Center

    Duluth, Minnesota 55805
    United States

    Site Not Available

  • St. Mary's - Duluth Clinic Cancer Center

    Duluth, Minnesota 55805
    United States

    Site Not Available

  • Fergus Falls, Minnesota 56537
    United States

    Site Not Available

  • Chippewa County - Montevideo Hospital

    Montevideo, Minnesota 56265
    United States

    Site Not Available

  • Mayo Clinic Cancer Center

    Rochester, Minnesota 55905
    United States

    Site Not Available

  • Coborn Cancer Center

    Saint Cloud, Minnesota 56303
    United States

    Site Not Available

  • Adult and Pediatric Urology, P.L.L.P.

    Sartell, Minnesota 56377
    United States

    Site Not Available

  • CentraCare Clinic - River Campus

    St. Cloud, Minnesota 56303
    United States

    Site Not Available

  • Willmar Cancer Center at Rice Memorial Hospital

    Willmar, Minnesota 56201
    United States

    Site Not Available

  • CCOP - Montana Cancer Consortium

    Billings, Montana 59101
    United States

    Site Not Available

  • Deaconess Billings Clinic - Downtown

    Billings, Montana 59107-7000
    United States

    Site Not Available

  • Hematology-Oncology Centers of the Northern Rockies - Billings

    Billings, Montana 59101
    United States

    Site Not Available

  • Northern Rockies Radiation Oncology Center

    Billings, Montana 59101
    United States

    Site Not Available

  • St. Vincent Healthcare

    Billings, Montana 59101
    United States

    Site Not Available

  • Bozeman Deaconess Hospital

    Bozeman, Montana 59715
    United States

    Site Not Available

  • St. James Community Hospital

    Butte, Montana 59701
    United States

    Site Not Available

  • Great Falls Clinic

    Great Falls, Montana 59405
    United States

    Site Not Available

  • St. Peter's Hospital

    Helena, Montana 59601
    United States

    Site Not Available

  • Glacier Oncology, PLLC

    Kalispell, Montana 59901
    United States

    Site Not Available

  • Kalispell Medical Oncology

    Kalispell, Montana 59901
    United States

    Site Not Available

  • Kalispell Regional Medical Center

    Kalispell, Montana 59901
    United States

    Site Not Available

  • Clinic of Dr. Judy L. Schmidt

    Missoula, Montana 59804
    United States

    Site Not Available

  • Community Medical Center

    Missoula, Montana 59801
    United States

    Site Not Available

  • Montana Cancer Center at St. Patrick Hospital and Health Sciences Center

    Missoula, Montana 59807
    United States

    Site Not Available

  • Montana Cancer Specialists at Montana Cancer Center

    Missoula, Montana 59807-7877
    United States

    Site Not Available

  • Cancer Resource Center - Lincoln

    Lincoln, Nebraska 68510
    United States

    Site Not Available

  • Alegant Health Cancer Center at Bergan Mercy Medical Center

    Omaha, Nebraska 68124
    United States

    Site Not Available

  • CCOP - Missouri Valley Cancer Consortium

    Omaha, Nebraska 68106
    United States

    Site Not Available

  • Creighton University Medical Center

    Omaha, Nebraska 68131-2197
    United States

    Site Not Available

  • Immanuel Medical Center

    Omaha, Nebraska 68122
    United States

    Site Not Available

  • Rutherford Hospital

    Rutherfordton, North Carolina 28139
    United States

    Site Not Available

  • Bismarck Cancer Center

    Bismarck, North Dakota 58501
    United States

    Site Not Available

  • Cancer Care Center at Medcenter One Hospital

    Bismarck, North Dakota 58501
    United States

    Site Not Available

  • Mid Dakota Clinic, P. C.

    Bismarck, North Dakota 58501
    United States

    Site Not Available

  • St. Alexius Medical Center

    Bismarck, North Dakota 58502
    United States

    Site Not Available

  • Wood County Oncology Center

    Bowling Green, Ohio 43402
    United States

    Site Not Available

  • CCOP - Columbus

    Columbus, Ohio 43215
    United States

    Site Not Available

  • Doctors Hospital at Ohio Health

    Columbus, Ohio 43228
    United States

    Site Not Available

  • Grant Riverside Cancer Services

    Columbus, Ohio 43215
    United States

    Site Not Available

  • Mount Carmel Health - West Hospital

    Columbus, Ohio 43222
    United States

    Site Not Available

  • Riverside Methodist Hospital Cancer Care

    Columbus, Ohio 43214-3998
    United States

    Site Not Available

  • Grady Memorial Hospital

    Delaware, Ohio 43015
    United States

    Site Not Available

  • Blanchard Valley Medical Associates

    Findlay, Ohio 45840
    United States

    Site Not Available

  • Fremont Memorial Hospital

    Fremont, Ohio 43420
    United States

    Site Not Available

  • Kenton Oncology, Incorporated

    Kenton, Ohio 43326
    United States

    Site Not Available

  • Fairfield Medical Center

    Lancaster, Ohio 43130
    United States

    Site Not Available

  • Lima Memorial Hospital

    Lima, Ohio 45804
    United States

    Site Not Available

  • Strecker Cancer Center at Marietta Memorial Hospital

    Marietta, Ohio 45750
    United States

    Site Not Available

  • Northwest Ohio Oncology Center

    Maumee, Ohio 43537
    United States

    Site Not Available

  • St. Luke's Hospital

    Maumee, Ohio 43537
    United States

    Site Not Available

  • Licking Memorial Cancer Care Program at Licking Memorial Hospital

    Newark, Ohio 43055
    United States

    Site Not Available

  • St. Charles Mercy Hospital

    Oregon, Ohio 43616
    United States

    Site Not Available

  • Toledo Clinic - Oregon

    Oregon, Ohio 43616
    United States

    Site Not Available

  • Firelands Regional Medical Center

    Sandusky, Ohio 44870
    United States

    Site Not Available

  • North Coast Cancer Care, Incorporated

    Sandusky, Ohio 44870
    United States

    Site Not Available

  • Community Hospital of Springfield and Clark County

    Springfield, Ohio 45505
    United States

    Site Not Available

  • Mercy Medical Center

    Springfield, Ohio 45504
    United States

    Site Not Available

  • Flower Hospital Cancer Center

    Sylvania, Ohio 43560
    United States

    Site Not Available

  • Mercy Hospital of Tiffin

    Tiffin, Ohio 44883
    United States

    Site Not Available

  • CCOP - Toledo Community Hospital

    Toledo, Ohio 43617
    United States

    Site Not Available

  • Medical University of Ohio Cancer Center

    Toledo, Ohio 43614
    United States

    Site Not Available

  • St. Vincent Mercy Medical Center

    Toledo, Ohio 43608
    United States

    Site Not Available

  • Toledo Clinic, Incorporated - Main Clinic

    Toledo, Ohio 43623
    United States

    Site Not Available

  • Toledo Hospital

    Toledo, Ohio 43606
    United States

    Site Not Available

  • Fulton County Health Center

    Wauseon, Ohio 43567
    United States

    Site Not Available

  • Mount Carmel Cancer Services at Mount Carmel St. Ann's Hospital

    Westerville, Ohio 43081
    United States

    Site Not Available

  • Genesis - Good Samaritan Hospital

    Zanesville, Ohio 43701
    United States

    Site Not Available

  • Allegheny Cancer Center at Allegheny General Hospital

    Pittsburgh, Pennsylvania 15212
    United States

    Site Not Available

  • AnMed Health Cancer Center

    Anderson, South Carolina 29621
    United States

    Site Not Available

  • CCOP - Upstate Carolina

    Spartanburg, South Carolina 29303
    United States

    Site Not Available

  • Gibbs Regional Cancer Center at Spartanburg Regional Medical Center

    Spartanburg, South Carolina 29303
    United States

    Site Not Available

  • Rapid City Regional Hospital

    Rapid City, South Dakota 57701
    United States

    Site Not Available

  • Welch Cancer Center at Sheridan Memorial Hospital

    Sheridan, Wyoming 82801
    United States

    Site Not Available

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