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Phase III Double-Blind, Placebo-Controlled Study of Gabapentin for the Prevention of Delayed CINV (Chemotherapy Induced Nausea and Vomiting) in Patients Receiving Highly Emetogenic Chemotherapy


Phase 3
18 Years
N/A
Open (Enrolling)
Both
Nausea and Vomiting, Unspecified Adult Solid Tumor, Protocol Specific

Thank you

Trial Information

Phase III Double-Blind, Placebo-Controlled Study of Gabapentin for the Prevention of Delayed CINV (Chemotherapy Induced Nausea and Vomiting) in Patients Receiving Highly Emetogenic Chemotherapy


OBJECTIVES:

- To evaluate the effectiveness of gabapentin in controlling delayed chemotherapy-induced
nausea and vomiting (CINV) in patients receiving highly emetogenic chemotherapy as
defined by the percentage of complete responders (no emetic episodes and no rescue
medication) on days 2 through 6 (five days after receipt of highly emetogenic
chemotherapy) compared to an effective prophylactic regimen.

- To evaluate the effectiveness of gabapentin in controlling delayed CINV in patients
receiving highly emetogenic chemotherapy as defined by the percentage of complete
responders (no emetic episodes, no more than mild nausea, and no rescue medication) on
days 2 through 6 compared to an effective prophylactic regimen.

- To compare the effectiveness of these regimens in controlling acute CINV on day 1 of
treatment in these patients.

- To compare the use of rescue agents in these patients.

- To determine the tolerability of gabapentin in these patients.

- To evaluate the effect of gabapentin for delayed chemotherapy-induced nausea and
vomiting on symptom distress and functional abilities in these patients.

- To compare alternative endpoints and methods for assessing nausea and vomiting and to
determine how these measures compare to patient's satisfaction with symptom control,
distress and function.

OUTLINE: This is a multicenter study. Patients are stratified according to gender, age (< 50
years vs > 50 years), history of alcoholism (yes vs no), and history of motion sickness or
history of pregnancy induced nausea/vomiting (yes vs no). Patients are randomized to 1 of 2
treatment arms.

- Arm I: Patients receive oral dexamethasone with 5HT3 receptor antagonist and oral
gabapentin once daily on day 1 of chemotherapy. Patients then receive oral
dexamethasone twice daily with or without 5HT3 receptor antagonist on days 2-4, and
oral gabapentin either two or three times daily on days 2-5 of chemotherapy.

- Arm II: Patients receive oral dexamethasone with 5HT3 receptor antagonist and oral
placebo once daily on day 1 of chemotherapy. Patients then receive oral dexamethasone
twice daily with or without 5HT3 receptor antagonist on days 2-4, and oral placebo
either two or three times daily on days 2-5 of chemotherapy.

Patients complete a Functional Living Index - Emesis questionnaire, an overall satisfaction
survey, and a side effect experience diary at baseline and on day 6. Patients also complete
a nausea and vomiting diary at baseline and periodically during study therapy.

Inclusion Criteria


DISEASE CHARACTERISTICS:

- Scheduled to receive highly emetogenic chemotherapy

- May be scheduled to receive prophylactic treatment for acute nausea and vomiting
with a 5HT3 antagonist and dexamethasone 20 mg on day 1 of chemotherapy
treatment

- May be scheduled to receive multiple day chemotherapy regimens as long as the
chemotherapy drugs given on the subsequent days have mild or no emetogenic
potential

- Chemotherapy schedules must allow at least 7 days rest between courses involving
administration of highly emetogenic chemotherapy

- No primary CNS malignancy and/or CNS metastasis

PATIENT CHARACTERISTICS:

- ECOG performance status 0-2

- Life expectancy ≥ 3 months

- Creatinine ≤ 1.5 times upper limit of normal within the past 30 days

- Not pregnant or nursing

- Negative pregnancy test

- Fertile patients must use effective contraception

- Ability to complete questionnaire(s) by his/herself or with assistance

- Able to swallow pills

- No epilepsy or seizure history

- No gastrointestinal obstruction, active peptic ulcer disease, or uncontrolled
heartburn

- No history of nausea and/or vomiting related to any kind of chemotherapy

- No nausea or vomiting within the past 3 days

- No history of allergic or other adverse reaction to gabapentin or pregabalin

PRIOR CONCURRENT THERAPY:

- See Disease Characteristics

- No prior moderate or highly emetogenic chemotherapy

- No prior or concurrent aprepitant or any other NK-1 receptor antagonist

- At least 1 months since prior and no concurrent gabapentin, pregabalin, or other
anticonvulsants

- At least 7 days since prior and no concurrent pelvic or abdominal radiotherapy

- At least 3 days since prior antiemetics

- No concurrent or planned use of lorazepam, diphenhydramine, eszopiclone, and/or
dronabinol during the 6 days of this study, except for treatment of breakthrough
nausea and vomiting

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Masking: Double-Blind, Primary Purpose: Supportive Care

Outcome Measure:

Comparison of percentage of complete responders, with complete response being defined as no emetic episodes and no use of rescue therapy for days 2 through 6

Safety Issue:

No

Principal Investigator

Debra Barton, RN, PhD, AOCN, FAAN

Investigator Role:

Principal Investigator

Investigator Affiliation:

Mayo Clinic

Authority:

United States: Federal Government

Study ID:

CDR0000634077

NCT ID:

NCT00880191

Start Date:

April 2009

Completion Date:

Related Keywords:

  • Nausea and Vomiting
  • Unspecified Adult Solid Tumor, Protocol Specific
  • nausea and vomiting
  • unspecified adult solid tumor, protocol specific
  • Nausea
  • Vomiting

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Location

Mayo Clinic Scottsdale Scottsdale, Arizona  85259
Mayo Clinic - Jacksonville Jacksonville, Florida  32224
Mayo Clinic Cancer Center Rochester, Minnesota  55905
CCOP - Upstate Carolina Spartanburg, South Carolina  29303
CCOP - Wichita Wichita, Kansas  67214-3882
Hurley Medical Center Flint, Michigan  48503
CCOP - Missouri Valley Cancer Consortium Omaha, Nebraska  68131
CCOP - Illinois Oncology Research Association Peoria, Illinois  61602
CCOP - Carle Cancer Center Urbana, Illinois  61801
CCOP - Iowa Oncology Research Association Des Moines, Iowa  50309-1016
CCOP - Metro-Minnesota Saint Louis Park, Minnesota  55416
Aurora Presbyterian Hospital Aurora, Colorado  80012
Boulder Community Hospital Boulder, Colorado  80301-9019
Penrose Cancer Center at Penrose Hospital Colorado Springs, Colorado  80933
CCOP - Colorado Cancer Research Program Denver, Colorado  80224-2522
Porter Adventist Hospital Denver, Colorado  80210
Presbyterian - St. Luke's Medical Center Denver, Colorado  80218
St. Joseph Hospital Denver, Colorado  80218
Rose Medical Center Denver, Colorado  80220
Swedish Medical Center Englewood, Colorado  80110
St. Mary's Regional Cancer Center at St. Mary's Hospital and Medical Center Grand Junction, Colorado  81502
Sky Ridge Medical Center Lone Tree, Colorado  80124
Hope Cancer Care Center at Longmont United Hospital Longmont, Colorado  80502
St. Mary - Corwin Regional Medical Center Pueblo, Colorado  81004
North Suburban Medical Center Thornton, Colorado  80229
Rush-Copley Cancer Care Center Aurora, Illinois  60507
Saint Anthony Memorial Health Centers Michigan City, Indiana  46360
Mercy Medical Center - Sioux City Sioux City, Iowa  51104
Siouxland Hematology-Oncology Associates, LLP Sioux City, Iowa  51101
St. Luke's Regional Medical Center Sioux City, Iowa  51104
CCOP - Michigan Cancer Research Consortium Ann Arbor, Michigan  48106
Saint Joseph Mercy Cancer Center Ann Arbor, Michigan  48106-0995
Oakwood Cancer Center at Oakwood Hospital and Medical Center Dearborn, Michigan  48123-2500
Genesys Hurley Cancer Institute Flint, Michigan  48503
Van Elslander Cancer Center at St. John Hospital and Medical Center Grosse Pointe Woods, Michigan  48236
Sparrow Regional Cancer Center Lansing, Michigan  48912-1811
St. John Macomb Hospital Warren, Michigan  48093
MeritCare Bemidji Bemidji, Minnesota  56601
Fairview Ridges Hospital Burnsville, Minnesota  55337
Mercy and Unity Cancer Center at Mercy Hospital Coon Rapids, Minnesota  55433
Duluth Clinic Cancer Center - Duluth Duluth, Minnesota  55805-1983
CCOP - Duluth Duluth, Minnesota  55805
Miller - Dwan Medical Center Duluth, Minnesota  55805
Fairview Southdale Hospital Edina, Minnesota  55435
Mercy and Unity Cancer Center at Unity Hospital Fridley, Minnesota  55432
Hutchinson Area Health Care Hutchinson, Minnesota  55350
Minnesota Oncology Hematology, PA - Maplewood Maplewood, Minnesota  55109
HealthEast Cancer Care at St. John's Hospital Maplewood, Minnesota  55109
Hennepin County Medical Center - Minneapolis Minneapolis, Minnesota  55415
Virginia Piper Cancer Institute at Abbott - Northwestern Hospital Minneapolis, Minnesota  55407
Hubert H. Humphrey Cancer Center at North Memorial Outpatient Center Robbinsdale, Minnesota  55422-2900
St. Francis Cancer Center at St. Francis Medical Center Shakopee, Minnesota  55379
Park Nicollet Cancer Center St. Louis Park, Minnesota  55416
Regions Hospital Cancer Care Center St. Paul, Minnesota  55101
United Hospital St. Paul, Minnesota  55102
Ridgeview Medical Center Waconia, Minnesota  55387
Minnesota Oncology Hematology, PA - Woodbury Woodbury, Minnesota  55125
MeritCare Broadway Fargo, North Dakota  58122
CCOP - MeritCare Hospital Fargo, North Dakota  58122
Natalie Warren Bryant Cancer Center at St. Francis Hospital Tulsa, Oklahoma  74136
Sanford Cancer Center at Sanford USD Medical Center Sioux Falls, South Dakota  57117-5039
Medical X-Ray Center, PC Sioux Falls, South Dakota  57105
Marshfield Clinic - Marshfield Center Marshfield, Wisconsin  54449
Marshfield Clinic - Indianhead Center Rice Lake, Wisconsin  54868
Methodist Medical Center of Illinois Peoria, Illinois  61636
Memorial Hospital of South Bend South Bend, Indiana  46601
CCOP - Columbus Columbus, Ohio  43206
CCOP - Dayton Kettering, Ohio  45429
Hinsdale, Illinois  60521
CCOP - Northern Indiana CR Consortium South Bend, Indiana  46601
Saint Joseph Regional Medical Center South Bend, Indiana  46617
John Stoddard Cancer Center at Iowa Methodist Medical Center Des Moines, Iowa  50309
St. Vincent Mercy Medical Center Toledo, Ohio  43608
CCOP - Toledo Community Hospital Toledo, Ohio  43623-3456
Via Christi Cancer Center at Via Christi Regional Medical Center Wichita, Kansas  67214
Medical University of Ohio Cancer Center Toledo, Ohio  43614
Toledo Hospital Toledo, Ohio  43606
St. Vincent Hospital Regional Cancer Center Green Bay, Wisconsin  54307-3508
Green Bay Oncology, Limited - Escanaba Escanaba, Michigan  49431
Dickinson County Healthcare System Iron Mountain, Michigan  49801
St. Mary's Hospital Medical Center - Green Bay Green Bay, Wisconsin  54303
Green Bay Oncology, Limited at St. Vincent Hospital Regional Cancer Center Green Bay, Wisconsin  54301-3526
Green Bay Oncology, Limited at St. Mary's Hospital Green Bay, Wisconsin  54303
Bay Area Cancer Care Center at Bay Area Medical Center Marinette, Wisconsin  54143
Green Bay Oncology, Limited - Oconto Falls Oconto Falls, Wisconsin  54154
Green Bay Oncology, Limited - Sturgeon Bay Sturgeon Bay, Wisconsin  54235
North Colorado Medical Center Greeley, Colorado  80631
McKee Medical Center Loveland, Colorado  80539
Adena Regional Medical Center Chillicothe, Ohio  54601
Doctors Hospital at Ohio Health Columbus, Ohio  43228
Riverside Methodist Hospital Cancer Care Columbus, Ohio  43214
Grady Memorial Hospital Delaware, Ohio  43015
Fairfield Medical Center Lancaster, Ohio  43130
Strecker Cancer Center at Marietta Memorial Hospital Marietta, Ohio  45750
Licking Memorial Cancer Care Program at Licking Memorial Hospital Newark, Ohio  43055
Community Hospital of Springfield and Clark County Springfield, Ohio  45505
Genesis - Good Samaritan Hospital Zanesville, Ohio  43701
MBCCOP - Medical College of Georgia Cancer Center Augusta, Georgia  30912-3730
University of New Mexico Cancer Center Albuquerque, New Mexico  87131-5636
Virginia Commonwealth University Massey Cancer Center Richmond, Virginia  23298-0037
Saint Francis/Mount Sinai Regional Cancer Center at Saint Francis Hospital and Medical Center Hartford, Connecticut  06105
Elkhart General Hospital Elkhart, Indiana  46515
Howard Community Hospital Kokomo, Indiana  46904
South Bend Clinic South Bend, Indiana  46617
Lakeland Regional Cancer Care Center - St. Joseph St. Joseph, Michigan  49085
Mount Carmel Health - West Hospital Columbus, Ohio  43222
Front Range Cancer Specialists Fort Collins, Colorado  80528
Poudre Valley Hospital Fort Collins, Colorado  80524
St. Joseph Medical Center Bloomington, Illinois  61701
Graham Hospital Canton, Illinois  61520
Memorial Hospital Carthage, Illinois  62321
Eureka Community Hospital Eureka, Illinois  61530
Mason District Hospital Havana, Illinois  62644
McDonough District Hospital Macomb, Illinois  61455
BroMenn Regional Medical Center Normal, Illinois  61761
Community Cancer Center Normal, Illinois  61761
Community Hospital of Ottawa Ottawa, Illinois  61350
Oncology Hematology Associates of Central Illinois, PC - Ottawa Ottawa, Illinois  61350
Cancer Treatment Center at Pekin Hospital Pekin, Illinois  61554
Oncology Hematology Associates of Central Illinois, PC - Peoria Peoria, Illinois  61615
OSF St. Francis Medical Center Peoria, Illinois  61637
Proctor Hospital Peoria, Illinois  61614
Illinois Valley Community Hospital Peru, Illinois  61354
Perry Memorial Hospital Princeton, Illinois  61356
St. Francis Hospital and Health Centers - Beech Grove Campus Beech Grove, Indiana  46107
Center for Cancer Therapy at LaPorte Hospital and Health Services La Porte, Indiana  46350
Bettendorf, Iowa  52722
John Stoddard Cancer Center at Iowa Lutheran Hospital Des Moines, Iowa  50316-2301
Medical Oncology and Hematology Associates at John Stoddard Cancer Center Des Moines, Iowa  50309
Medical Oncology and Hematology Associates at Mercy Cancer Center Des Moines, Iowa  50314
Mercy Cancer Center at Mercy Medical Center - Des Moines Des Moines, Iowa  50314
Medical Oncology and Hematology Associates - West Des Moines West Des Moines, Iowa  50266
Cancer Center of Kansas, PA - Dodge City Dodge City, Kansas  67801
Hickman Cancer Center at Bixby Medical Center Adrian, Michigan  49221
Community Cancer Center of Monroe Monroe, Michigan  48162
Alexandria, Minnesota  56308
Coborn Cancer Center Saint Cloud, Minnesota  56303
CentraCare Clinic - River Campus St. Cloud, Minnesota  56303
Immanuel Medical Center Omaha, Nebraska  68122
Creighton University Medical Center Omaha, Nebraska  68131-2197
Bismarck Cancer Center Bismarck, North Dakota  58501
Wood County Oncology Center Bowling Green, Ohio  43402
Samaritan North Cancer Care Center Dayton, Ohio  45415
Grandview Hospital Dayton, Ohio  45405
David L. Rike Cancer Center at Miami Valley Hospital Dayton, Ohio  45409
Good Samaritan Hospital Dayton, Ohio  45406
Blanchard Valley Medical Associates Findlay, Ohio  45840
Charles F. Kettering Memorial Hospital Kettering, Ohio  45429
Lima Memorial Hospital Lima, Ohio  45804
St. Luke's Hospital Maumee, Ohio  43537
Northwest Ohio Oncology Center Maumee, Ohio  43537
Middletown Regional Hospital Middletown, Ohio  45044
Toledo Clinic - Oregon Oregon, Ohio  43616
St. Charles Mercy Hospital Oregon, Ohio  43616
North Coast Cancer Care, Incorporated Sandusky, Ohio  44870
Mercy Hospital of Tiffin Tiffin, Ohio  44883
Toledo Clinic, Incorporated - Main Clinic Toledo, Ohio  43623
UVMC Cancer Care Center at Upper Valley Medical Center Troy, Ohio  45373-1300
Fulton County Health Center Wauseon, Ohio  43567
Ruth G. McMillan Cancer Center at Greene Memorial Hospital Xenia, Ohio  45385
Holy Family Memorial Medical Center Cancer Care Center Manitowoc, Wisconsin  54221-1450
St. Anthony Central Hospital Denver, Colorado  80204-1335
Exempla Lutheran Medical Center Wheat Ridge, Colorado  80033
Missouri Baptist Cancer Center St. Louis, Missouri  63131
Cancer Resource Center - Lincoln Lincoln, Nebraska  68510
Altru Cancer Center at Altru Hospital Grand Forks, North Dakota  58201
Michiana Hematology-Oncology, PC - Elkhart Elkhart, Indiana  46514
Elkhart Clinic, LLC Elkhart, Indiana  46514-2098
Michiana Hematology Oncology PC - La Porte La Porte, Indiana  46350
Michiana Hematology-Oncology, PC - South Bend Mishawaka, Indiana  46545-1470
Michiana Hematology Oncology PC - Plymouth Plymouth, Indiana  46563
Reid Hospital & Health Care Services Richmond, Indiana  47374
McFarland Clinic, PC Ames, Iowa  50010
Cancer Center of Kansas, PA - Chanute Chanute, Kansas  66720
Cancer Center of Kansas, PA - El Dorado El Dorado, Kansas  67042
Cancer Center of Kansas - Fort Scott Fort Scott, Kansas  66701
Cancer Center of Kansas-Independence Independence, Kansas  67301
Cancer Center of Kansas, PA - Kingman Kingman, Kansas  67068
Lawrence Memorial Hospital Lawrence, Kansas  66044
Cancer Center of Kansas, PA - Liberal Liberal, Kansas  67905
Cancer Center of Kansas, PA - Newton Newton, Kansas  67114
Cancer Center of Kansas, PA - Parsons Parsons, Kansas  67357
Cancer Center of Kansas, PA - Pratt Pratt, Kansas  67124
Cancer Center of Kansas, PA - Salina Salina, Kansas  67401
Cancer Center of Kansas, PA - Wellington Wellington, Kansas  67152
Cancer Center of Kansas, PA - Wichita Wichita, Kansas  67214
Cancer Center of Kansas, PA - Medical Arts Tower Wichita, Kansas  67208
Cancer Center of Kansas, PA - Winfield Winfield, Kansas  67156
Foote Memorial Hospital Jackson, Michigan  49201
Haematology-Oncology Associates of Ohio and Michigan, PC Lambertville, Michigan  48144
St. Mary Mercy Hospital Livonia, Michigan  48154
Mercy Memorial Hospital - Monroe Monroe, Michigan  48162
Michiana Hematology Oncology PC - Niles Niles, Michigan  49120
St. Joseph Mercy Oakland Pontiac, Michigan  48341-2985
Mercy Regional Cancer Center at Mercy Hospital Port Huron, Michigan  48060
Seton Cancer Institute at Saint Mary's - Saginaw Saginaw, Michigan  48601
Lakeside Cancer Specialists, PLLC Saint Joseph, Michigan  49085
Fergus Falls Medical Group, PA Fergus Falls, Minnesota  56537
Willmar Cancer Center at Rice Memorial Hospital Willmar, Minnesota  56201
Arch Medical Services, Incorporated at Center for Cancer Care and Research Saint Louis, Missouri  63141
Alegant Health Cancer Center at Bergan Mercy Medical Center Omaha, Nebraska  68124
Mary Rutan Hospital Bellefontaine, Ohio  43311
North Coast Cancer Care - Clyde Clyde, Ohio  43410
Grant Medical Center Cancer Care Columbus, Ohio  43215
Hematology Oncology Center Elyria, Ohio  44035
Community Cancer Center Elyria, Ohio  44035
Wayne Hospital Greenville, Ohio  45331
Knox Community Hospital Mount Vernon, Ohio  43050
Fisher-Titus Medical Center Norwalk, Ohio  44857
Flower Hospital Cancer Center Sylvania, Ohio  43560
St. Anne Mercy Hospital Toledo, Ohio  43623
Mount Carmel St. Ann's Cancer Center Westerville, Ohio  43081
Clinton Memorial Hospital Wilmington, Ohio  45177
Fredericksburg Oncology, Incorporated Fredericksburg, Virginia  22401
Marshfield Clinic - Chippewa Center Chippewa Falls, Wisconsin  54729
Marshfield Clinic Cancer Care at Regional Cancer Center Eau Claire, Wisconsin  54701
Marshfield Clinic - Lakeland Center Minocqua, Wisconsin  54548
Ministry Medical Group at Saint Mary's Hospital Rhinelander, Wisconsin  54501
Marshfield Clinic at Saint Michael's Hospital Stevens Point, Wisconsin  54481
Marshfield Clinic - Weston Center Weston, Wisconsin  54476
Marshfield Clinic - Wisconsin Rapids Center Wisconsin Rapids, Wisconsin  54494
Mid Dakota Clinic, PC Bismarck, North Dakota  58501
Rutherford Hospital Rutherfordton, North Carolina  28139
Gibbs Regional Cancer Center at Spartanburg Regional Medical Center Spartanburg, South Carolina  29303
Galesburg Clinic, PC Galesburg, Illinois  61401
Illinois CancerCare - Bloomington Bloomington%, Illinois  61701
Illinois CancerCare - Canton Canton, Illinois  61520
Illinois CancerCare - Carthage Carthage, Illinois  62321
Illinois CancerCare - Eureka Eureka, Illinois  61530
Illinois CancerCare - Galesburg Galesburg, Illinois  61401
Illinois CancerCare - Havana Havana, Illinois  62644
Illinois CancerCare - Kewanee Clinic Kewanee, Illinois  61443
Illinois CancerCare - Macomb Macomb, Illinois  61455
Trinity Cancer Center at Trinity Medical Center - 7th Street Campus Moline, Illinois  61265
Illinois CancerCare - Monmouth Monmouth, Illinois  61462
Illinois CancerCare - Community Cancer Center Normal, Illinois  61761
Illinois CancerCare - Pekin Pekin, Illinois  61603
Illinois CancerCare - Peru Peru, Illinois  61354
Illinois CancerCare - Princeton Princeton, Illinois  61356
Illinois CancerCare - Spring Valley Spring Valley, Illinois  61362
United States Air Force Medical Center - Wright-Patterson Wright-Patterson AFB, Ohio  45433-5529
AnMed Cancer Center Anderson, South Carolina  29621
Medcenter One Hospital Cancer Care Center Bismarck, North Dakota  58501
St. Alexius Medical Center Cancer Center Bismarck, North Dakota  58502
Lovelace Medical Center - Downtown Albuquerque, New Mexico  87102
Immanuel St. Joseph's Mankato, Minnesota  56002
Comprehensive Cancer Care, PC Saint Louis, Missouri  63141