Baclofen-Amitriptyline Hydrochloride-Ketamine Gel in Treating Peripheral Neuropathy Caused by Chemotherapy in Patients With Cancer

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Alliance for Clinical Trials in Oncology
ClinicalTrials.gov Identifier:
NCT00516503
First received: August 14, 2007
Last updated: July 3, 2015
Last verified: July 2015
  Purpose

RATIONALE: Baclofen-amitriptyline-ketamine (BAK) gel may lessen peripheral neuropathy caused by chemotherapy. It is not yet known whether BAK gel is more effective than a placebo in treating peripheral neuropathy caused by chemotherapy .

PURPOSE: This randomized phase III trial is studying BAK gel to see how well it works compared with a placebo in treating peripheral neuropathy caused by chemotherapy in patients with cancer.


Condition Intervention Phase
Chronic Myeloproliferative Disorders
Leukemia
Lymphoma
Lymphoproliferative Disorder
Multiple Myeloma and Plasma Cell Neoplasm
Myelodysplastic Syndromes
Myelodysplastic/Myeloproliferative Neoplasms
Neurotoxicity
Pain
Unspecified Adult Solid Tumor, Protocol Specific
Drug: baclofen/amitriptyline/ketamine gel
Other: placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Supportive Care
Official Title: The Use of Topical Baclofen, Amitriptyline HCI, and Ketamine (BAK) in a PLO Gel vs. Placebo for the Treatment of Chemotherapy Induced Peripheral Neuropathy: A Phase III Randomized Double-Blind Placebo Controlled Study

Resource links provided by NLM:


Further study details as provided by Alliance for Clinical Trials in Oncology:

Primary Outcome Measures:
  • Total sensory neuropathy (area under the curve [AUC]) as measured by the EORTC QLQ-CIPN20 at baseline and week 4 [ Time Frame: Up to 4 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Motor neuropathy as measured by the EORTC QLQ-CIPN20 at baseline and week 4 [ Time Frame: Up to 4 weeks ] [ Designated as safety issue: No ]
  • Autonomic symptoms and functioning as measured by the EORTC QLQ-CIPN20 at baseline and week 4 [ Time Frame: Up to 4 weeks ] [ Designated as safety issue: No ]
  • Mood states and total mood disturbance as measured by the Profile of Mood States-Brief at baseline and week 4 [ Time Frame: Up to 4 weeks ] [ Designated as safety issue: No ]
  • Pain severity and interference as measured by the Brief Pain Inventory at baseline and week 4 [ Time Frame: Up to 4 weeks ] [ Designated as safety issue: No ]
  • Numbness, tingling, and pain as measured by the Peripheral Neuropathy Questionnaire at baseline and weekly for 4 weeks [ Time Frame: Up to 4 weeks ] [ Designated as safety issue: No ]
  • Perception of benefit as measured by the Subject Global Impression of Change at the end of week 4 [ Time Frame: Up to 4 weeks ] [ Designated as safety issue: No ]
  • Frequency and severity of adverse events reported by the patient in the Symptom Experience Diary and evaluated through clinical assessment by NCI CTCAE v3.0 [ Time Frame: Up to 4 weeks ] [ Designated as safety issue: Yes ]

Enrollment: 211
Study Start Date: February 2008
Study Completion Date: January 2010
Primary Completion Date: April 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Arm I
Patients apply 1 spoonful of baclofen-amitriptyline hydrochloride-ketamine gel topically to each area of pain, numbness, and/or tingling on the feet and/or hands twice daily for 4 weeks.
Drug: baclofen/amitriptyline/ketamine gel
Applied topically
Placebo Comparator: Arm II
Patients apply 1 spoonful of placebo gel topically to each area of pain, numbness, and/or tingling on the feet and/or hands twice daily for 4 weeks.
Other: placebo
Applied topically

Detailed Description:

OBJECTIVES:

Primary

  • Compare the effectiveness of baclofen-amitriptyline hydrochloride-ketamine (BAK) gel versus placebo, in terms of improving sensory neuropathy, in cancer patients with chemotherapy-induced peripheral neuropathy.

Secondary

  • Compare motor and autonomic symptoms and functioning, mood states, pain, and peripheral neuropathy in these patients.
  • Assess the adverse event profile of topical BAK gel.
  • Explore whether topical BAK gel is absorbed systemically.

OUTLINE: Patients are stratified according to neurotoxic chemotherapy (active vs non-active), current use of opioids or oral pain medications (yes vs no), pain rating (4-7 vs 8-10), and prior ineffective pharmacologic treatment for peripheral neuropathy (yes vs no). Patients are randomized to 1 of 2 treatment arms.

  • Arm I: Patients apply 1 spoonful of baclofen-amitriptyline hydrochloride-ketamine gel topically to each area of pain, numbness, and/or tingling on the feet and/or hands twice daily for 4 weeks.
  • Arm II: Patients apply 1 spoonful of placebo gel topically to each area of pain, numbness, and/or tingling on the feet and/or hands twice daily for 4 weeks.

Some patients in both arms may choose to continue on the active gel or, if on placebo, begin the active gel for an additional 8 weeks off study.

Patients complete health, pain, mood, and quality of life questionnaires at baseline and periodically during study. Patients also record adverse symptoms weekly in a Symptom Experience Diary.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

DISEASE CHARACTERISTICS:

  • Diagnosis of cancer
  • Received or currently receiving neurotoxic chemotherapy including, but not limited to, taxanes (e.g., paclitaxel or docetaxel); platinum-based compounds (e.g., carboplatin, cisplatin, or oxaliplatin); vinca alkaloids (e.g., vincristine or vinblastine); or other neurotoxic chemotherapy agents (e.g., bortezomib, lenalidomide, or thalidomide)
  • Must have pain or symptoms of peripheral neuropathy attributable to chemotherapy for ≥ 1 month

    • Neuropathy is limited to either hands and/or feet where gel can be applied
    • Neuropathic pain score of ≥ 4 out of 10 on the numbness/tingling/pain numeric analogue scale
  • No pre-existing or history of peripheral neuropathy due to any cause other than chemotherapy (e.g., diabetes, alcohol, toxin, heredity)

PATIENT CHARACTERISTICS:

  • ECOG performance status 0-2
  • Life expectancy ≥ 4 months
  • Creatinine ≤ 1.5 times upper limit of normal
  • Not pregnant or nursing
  • No ability to bear children defined by 1 of the criteria:

    • Menopausal (12 months and no menstrual period if natural menopause)
    • Underwent a hysterectomy and/or oophorectomy
    • Permanent surgical sterilization (tubal ligation)
  • Fertile patients must use effective contraception
  • Able to complete questionnaires independently or with assistance
  • Able to sign informed consent and understand the nature of a placebo-controlled trial
  • No history of an allergic reaction to baclofen, amitriptyline hydrochloride, and/or ketamine
  • No diagnosis of any New York Heart Association class I-IV congestive heart failure
  • No diagnosis of coronary artery disease including, but not limited to, myocardial infarction, within the past 5 years
  • No other medical condition that, in the opinion of the treating physician or allied health professional, would make this clinical trial unreasonably hazardous for the patient
  • No skin abnormalities at the intended application sites (hands and feet) of study gel (i.e., skin breakdown)

PRIOR CONCURRENT THERAPY:

  • See Disease Characteristics
  • More than 30 days since prior anticonvulsants, tricyclic antidepressants, monoamine oxidase inhibitor, or other neuropathic pain medication (e.g., carbamazepine, phenytoin, valproic acid, gabapentin, lamotrigine, topical lidocaine patch or gel, capsaicin cream, or amifostine)

    • Patients treated with any of these agents for peripheral neuropathy for ≤ 1 week during the past 30 days are eligible provided they are no longer taking the agent
  • More than 5 years since prior percutaneous transluminal coronary angioplasty or coronary artery bypass graft

    • Prior heart valve replacement surgery allowed provided patient has fully recovered from the surgery
  • No concurrent use of study agents other than as specified in the trial
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00516503

  Hide Study Locations
Locations
United States, Arizona
Mayo Clinic Scottsdale
Scottsdale, Arizona, United States, 85259-5499
United States, Florida
Mayo Clinic - Jacksonville
Jacksonville, Florida, United States, 32224
United States, Illinois
Rush-Copley Cancer Care Center
Aurora, Illinois, United States, 60504
St. Joseph Medical Center
Bloomington, Illinois, United States, 61701
Graham Hospital
Canton, Illinois, United States, 61520
Memorial Hospital
Carthage, Illinois, United States, 62321
Eureka Community Hospital
Eureka, Illinois, United States, 61530
Galesburg Clinic, PC
Galesburg, Illinois, United States, 61401
Galesburg Cottage Hospital
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
McDonough District Hospital
Macomb, Illinois, United States, 61455
Moline, Illinois, United States, 61265
Community Cancer Center
Normal, Illinois, United States, 61761
Community Hospital of Ottawa
Ottawa, Illinois, United States, 61350
Oncology Hematology Associates of Central Illinois, PC - 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
Proctor Hospital
Peoria, Illinois, United States, 61614
Oncology Hematology Associates of Central Illinois, PC - Peoria
Peoria, Illinois, United States, 61615
OSF St. Francis Medical Center
Peoria, Illinois, United States, 61637
Methodist Medical Center of Illinois
Peoria, Illinois, United States, 61636
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
United States, Indiana
St. Francis Hospital and Health Centers - Beech Grove Campus
Beech Grove, Indiana, United States, 46107
Elkhart General Hospital
Elkhart, Indiana, United States, 46515
Howard Community Hospital
Kokomo, Indiana, United States, 46904
Center for Cancer Therapy at LaPorte Hospital and Health Services
La Porte, Indiana, United States, 46350
Saint Anthony Memorial Health Centers
Michigan City, Indiana, United States, 46360
Reid Hospital & Health Care Services
Richmond, Indiana, United States, 47374
Saint Joseph Regional Medical Center
South Bend, Indiana, United States, 46617
Memorial Hospital of South Bend
South Bend, Indiana, United States, 46601
CCOP - Northern Indiana CR Consortium
South Bend, Indiana, United States, 46601
United States, Iowa
McFarland Clinic, PC
Ames, Iowa, United States, 50010
Bettendorf, Iowa, United States, 52722
Cedar Rapids Oncology Associates
Cedar Rapids, Iowa, United States, 52403
Mercy Medical Center - Sioux City
Sioux City, Iowa, United States, 51104
Siouxland Hematology-Oncology Associates, LLP
Sioux City, Iowa, United States, 51101
St. Luke's Regional Medical Center
Sioux City, Iowa, United States, 51104
United States, Michigan
Hickman Cancer Center at Bixby Medical Center
Adrian, Michigan, United States, 49221
Haematology-Oncology Associates of Ohio and Michigan, PC
Lambertville, Michigan, United States, 48144
Community Cancer Center of Monroe
Monroe, Michigan, United States, 48162
Mercy Memorial Hospital - Monroe
Monroe, Michigan, United States, 48162
Lakeland Regional Cancer Care Center - St. Joseph
St. Joseph, Michigan, United States, 49085
United States, Minnesota
MeritCare Bemidji
Bemidji, Minnesota, United States, 56601
Fairview Ridges Hospital
Burnsville, Minnesota, United States, 55337
Mercy and Unity Cancer Center at Mercy Hospital
Coon Rapids, Minnesota, United States, 55433
Miller - Dwan Medical Center
Duluth, Minnesota, United States, 55805
Duluth Clinic Cancer Center - Duluth
Duluth, Minnesota, United States, 55805-1983
CCOP - Duluth
Duluth, Minnesota, United States, 55805
Fairview Southdale Hospital
Edina, Minnesota, United States, 55435
Mercy and Unity Cancer Center at Unity Hospital
Fridley, Minnesota, United States, 55432
Immanuel St. Joseph's
Mankato, Minnesota, United States, 56002
Minnesota Oncology Hematology, PA - Maplewood
Maplewood, Minnesota, United States, 55109
Virginia Piper Cancer Institute at Abbott - Northwestern Hospital
Minneapolis, Minnesota, United States, 55407
Hubert H. Humphrey Cancer Center at North Memorial Outpatient Center
Robbinsdale, Minnesota, United States, 55422-2900
Mayo Clinic Cancer Center
Rochester, Minnesota, United States, 55905
Park Nicollet Cancer Center
Saint Louis Park, Minnesota, United States, 55416
CCOP - Metro-Minnesota
Saint Louis Park, Minnesota, United States, 55416
United Hospital
Saint Paul, Minnesota, United States, 55102
Ridgeview Medical Center
Waconia, Minnesota, United States, 55387
Willmar Cancer Center at Rice Memorial Hospital
Willmar, Minnesota, United States, 56201
Minnesota Oncology Hematology, PA - Woodbury
Woodbury, Minnesota, United States, 55125
United States, Montana
Hematology-Oncology Centers of the Northern Rockies - Billings
Billings, Montana, United States, 59101
CCOP - Montana Cancer Consortium
Billings, Montana, United States, 59101
Billings Clinic - Downtown
Billings, Montana, United States, 59107-7000
Northern Rockies Radiation Oncology Center
Billings, Montana, United States, 59101
St. Vincent Healthcare Cancer Care Services
Billings, Montana, United States, 59101
St. James Healthcare Cancer Care
Butte, Montana, United States, 59701
Great Falls, Montana, United States, 59405
Big Sky Oncology
Great Falls, Montana, United States, 59405-5309
Great Falls Clinic - Main Facility
Great Falls, Montana, United States, 59405
Sletten Cancer Institute at Benefis Healthcare
Great Falls, Montana, United States, 59405
Glacier Oncology, PLLC
Kalispell, Montana, United States, 59901
Kalispell Medical Oncology at KRMC
Kalispell, Montana, United States, 59901
Kalispell Regional Medical Center
Kalispell, Montana, United States, 59901
Montana Cancer Specialists at Montana Cancer Center
Missoula, Montana, United States, 59807-7877
Guardian Oncology and Center for Wellness
Missoula, Montana, United States, 59804
Montana Cancer Center at St. Patrick Hospital and Health Sciences Center
Missoula, Montana, United States, 59807
Community Medical Center
Missoula, Montana, United States, 59801
United States, Nebraska
Cancer Resource Center - Lincoln
Lincoln, Nebraska, United States, 68510
Creighton University Medical Center
Omaha, Nebraska, United States, 68131-2197
CCOP - Missouri Valley Cancer Consortium
Omaha, Nebraska, United States, 68106
Immanuel Medical Center
Omaha, Nebraska, United States, 68122
Alegant Health Cancer Center at Bergan Mercy Medical Center
Omaha, Nebraska, United States, 68124
United States, North Carolina
Rutherford Hospital
Rutherfordton, North Carolina, United States, 28139
United States, North Dakota
St. Alexius Medical Center Cancer Center
Bismarck, North Dakota, United States, 58502
Bismarck Cancer Center
Bismarck, North Dakota, United States, 58501
Medcenter One Hospital Cancer Care Center
Bismarck, North Dakota, United States, 58501
Mid Dakota Clinic, PC
Bismarck, North Dakota, United States, 58501
MeritCare Broadway
Fargo, North Dakota, United States, 58122
CCOP - MeritCare Hospital
Fargo, North Dakota, United States, 58122
Altru Cancer Center at Altru Hospital
Grand Forks, North Dakota, United States, 58201
United States, Ohio
Mary Rutan Hospital
Bellefontaine, Ohio, United States, 43311
Wood County Oncology Center
Bowling Green, Ohio, United States, 43402
Adena Regional Medical Center
Chillicothe, Ohio, United States, 45601
North Coast Cancer Care - Clyde
Clyde, Ohio, United States, 43410
CCOP - Columbus
Columbus, Ohio, United States, 43215
Doctors Hospital at Ohio Health
Columbus, Ohio, United States, 43228
Grant Medical Center Cancer Care
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
CCOP - Dayton
Dayton, Ohio, United States, 45429
Good Samaritan Hospital
Dayton, Ohio, United States, 45406
Grandview Hospital
Dayton, Ohio, United States, 45405
Samaritan North Cancer Care Center
Dayton, Ohio, United States, 45415
Grady Memorial Hospital
Delaware, Ohio, United States, 43015
Hematology Oncology Center
Elyria, Ohio, United States, 44035
Blanchard Valley Medical Associates
Findlay, Ohio, United States, 45840
Middletown Regional Hospital
Franklin, Ohio, United States, 45005-1066
Charles F. Kettering Memorial Hospital
Kettering, Ohio, United States, 45429
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
St. Charles Mercy Hospital
Oregon, Ohio, United States, 43616
Toledo Clinic - Oregon
Oregon, Ohio, United States, 43616
North Coast Cancer Care, Incorporated
Sandusky, Ohio, United States, 44870
Community Hospital of Springfield and Clark County
Springfield, Ohio, United States, 45505
Mercy Medical Center
Springfield, Ohio, United States, 45504
Flower Hospital Cancer Center
Sylvania, Ohio, United States, 43560
Mercy Hospital of Tiffin
Tiffin, Ohio, United States, 44883
CCOP - Toledo Community Hospital
Toledo, Ohio, United States, 43617
Medical University of Ohio Cancer Center
Toledo, Ohio, United States, 43614
St. Anne Mercy Hospital
Toledo, Ohio, United States, 43623
St. Vincent Mercy Medical Center
Toledo, Ohio, United States, 43608
Toledo Clinic, Incorporated - Main Clinic
Toledo, Ohio, United States, 43623
Toledo Hospital
Toledo, Ohio, United States, 43606
UVMC Cancer Care Center at Upper Valley Medical Center
Troy, Ohio, United States, 45373-1300
Fulton County Health Center
Wauseon, Ohio, United States, 43567
Mount Carmel St. Ann's Cancer Center
Westerville, Ohio, United States, 43081
Clinton Memorial Hospital
Wilmington, Ohio, United States, 45177
Ruth G. McMillan Cancer Center at Greene Memorial Hospital
Xenia, Ohio, United States, 45385
Genesis - Good Samaritan Hospital
Zanesville, Ohio, United States, 43701
United States, Oregon
Legacy Mount Hood Medical Center
Gresham, Oregon, United States, 97030
Providence Milwaukie Hospital
Milwaukie, Oregon, United States, 97222
Providence Cancer Center at Providence Portland Medical Center
Portland, Oregon, United States, 97213-2967
CCOP - Columbia River Oncology Program
Portland, Oregon, United States, 97225
Legacy Emanuel Hospital and Health Center and Children's Hospital
Portland, Oregon, United States, 97227
Legacy Good Samaritan Hospital & Comprehensive Cancer Center
Portland, Oregon, United States, 97210
Adventist Medical Center
Portland, Oregon, United States, 97216
Providence St. Vincent Medical Center
Portland, Oregon, United States, 97225
Legacy Meridian Park Hospital
Tualatin, Oregon, United States, 97062
United States, Pennsylvania
Geisinger Cancer Institute at Geisinger Health
Danville, Pennsylvania, United States, 17822-0001
Geisinger Hazleton Cancer Center
Hazleton, Pennsylvania, United States, 18201
Guthrie Cancer Center at Guthrie Clinic Sayre
Sayre, Pennsylvania, United States, 18840
Geisinger Medical Group - Scenery Park
State College, Pennsylvania, United States, 16801
Frank M. and Dorothea Henry Cancer Center at Geisinger Wyoming Valley Medical Center
Wilkes-Barre, Pennsylvania, United States, 18711
Mercy Hospital at Wilkes-Barre
Wilkes-Barre, Pennsylvania, United States, 18765
United States, South Carolina
AnMed 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
United States, South Dakota
Rapid City Regional Hospital
Rapid City, South Dakota, United States, 57701
Avera Cancer Institute
Sioux Falls, South Dakota, United States, 57105
Medical X-Ray Center, PC
Sioux Falls, South Dakota, United States, 57105
Sanford Cancer Center at Sanford USD Medical Center
Sioux Falls, South Dakota, United States, 57117-5039
United States, Virginia
Fredericksburg Oncology, Incorporated
Fredericksburg, Virginia, United States, 22401
United States, Washington
Southwest Washington Medical Center Cancer Center
Vancouver, Washington, United States, 98668
United States, Wisconsin
Franciscan Skemp Healthcare - La Crosse Campus
La Crosse, Wisconsin, United States, 54601
Sponsors and Collaborators
Alliance for Clinical Trials in Oncology
Investigators
Study Chair: Debra Barton, RN, PhD, AOCN, FAAN Mayo Clinic
  More Information

Additional Information:
Publications:
Responsible Party: Alliance for Clinical Trials in Oncology
ClinicalTrials.gov Identifier: NCT00516503     History of Changes
Other Study ID Numbers: NCCTG-N06CA, NCI-2011-01768, CDR0000560732
Study First Received: August 14, 2007
Last Updated: July 3, 2015
Health Authority: United States: Federal Government

Additional relevant MeSH terms:
Lymphoproliferative Disorders
Multiple Myeloma
Myelodysplastic Syndromes
Myelodysplastic-Myeloproliferative Diseases
Myeloproliferative Disorders
Neoplasms
Neoplasms, Plasma Cell
Neurotoxicity Syndromes
Peripheral Nervous System Diseases
Plasmacytoma
Preleukemia
Blood Protein Disorders
Bone Marrow Diseases
Cardiovascular Diseases
Chemically-Induced Disorders
Hematologic Diseases
Hemorrhagic Disorders
Hemostatic Disorders
Immune System Diseases
Immunoproliferative Disorders
Lymphatic Diseases
Neoplasms by Histologic Type
Nervous System Diseases
Neuromuscular Diseases
Paraproteinemias
Poisoning
Precancerous Conditions
Vascular Diseases
Amitriptyline
Amitriptyline, perphenazine drug combination

ClinicalTrials.gov processed this record on July 28, 2015