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

Information source: Alliance for Clinical Trials in Oncology
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: 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

Intervention: baclofen/amitriptyline/ketamine gel (Drug); placebo (Other)

Phase: Phase 3

Status: Completed

Sponsored by: Alliance for Clinical Trials in Oncology

Official(s) and/or principal investigator(s):
Debra Barton, RN, PhD, AOCN, FAAN, Study Chair, Affiliation: Mayo Clinic

Summary

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.

Clinical Details

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

Study design: Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Supportive Care

Primary outcome: Total sensory neuropathy (area under the curve [AUC]) as measured by the EORTC QLQ-CIPN20 at baseline and week 4

Secondary outcome:

Motor neuropathy as measured by the EORTC QLQ-CIPN20 at baseline and week 4

Autonomic symptoms and functioning as measured by the EORTC QLQ-CIPN20 at baseline and week 4

Mood states and total mood disturbance as measured by the Profile of Mood States-Brief at baseline and week 4

Pain severity and interference as measured by the Brief Pain Inventory at baseline and week 4

Numbness, tingling, and pain as measured by the Peripheral Neuropathy Questionnaire at baseline and weekly for 4 weeks

Perception of benefit as measured by the Subject Global Impression of Change at the end of week 4

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

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

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

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

Locations and Contacts

Mayo Clinic Scottsdale, Scottsdale, Arizona 85259-5499, United States

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

Rush-Copley Cancer Care Center, Aurora, Illinois 60504, United States

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

Graham Hospital, Canton, Illinois 61520, United States

Memorial Hospital, Carthage, Illinois 62321, United States

Eureka Community Hospital, Eureka, Illinois 61530, United States

Galesburg Clinic, PC, Galesburg, Illinois 61401, United States

Galesburg Cottage Hospital, Galesburg, Illinois 61401, United States

Mason District Hospital, Havana, Illinois 62644, United States

Hopedale Medical Complex, Hopedale, Illinois 61747, United States

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

McDonough District Hospital, Macomb, Illinois 61455, United States

Moline, Illinois 61265, United States

Community Cancer Center, Normal, Illinois 61761, United States

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

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

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

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

Methodist Medical Center of Illinois, Peoria, Illinois 61636, 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

Proctor Hospital, Peoria, Illinois 61614, United States

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

Perry Memorial Hospital, Princeton, Illinois 61356, United States

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

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

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

St. Francis Hospital and Health Centers - Beech Grove Campus, Beech Grove, Indiana 46107, United States

Elkhart General Hospital, Elkhart, Indiana 46515, United States

Howard Community Hospital, Kokomo, Indiana 46904, United States

Center for Cancer Therapy at LaPorte Hospital and Health Services, La Porte, Indiana 46350, United States

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

Reid Hospital & Health Care Services, Richmond, Indiana 47374, United States

CCOP - Northern Indiana CR Consortium, South Bend, Indiana 46601, United States

Memorial Hospital of South Bend, South Bend, Indiana 46601, United States

Saint Joseph Regional Medical Center, South Bend, Indiana 46617, United States

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

Bettendorf, Iowa 52722, United States

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

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

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

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

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

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

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

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

Lakeland Regional Cancer Care Center - St. Joseph, St. Joseph, Michigan 49085, United States

MeritCare Bemidji, Bemidji, Minnesota 56601, United States

Fairview Ridges Hospital, Burnsville, Minnesota 55337, United States

Mercy and Unity Cancer Center at Mercy Hospital, Coon Rapids, Minnesota 55433, United States

CCOP - Duluth, Duluth, Minnesota 55805, United States

Duluth Clinic Cancer Center - Duluth, Duluth, Minnesota 55805-1983, United States

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

Fairview Southdale Hospital, Edina, Minnesota 55435, United States

Mercy and Unity Cancer Center at Unity Hospital, Fridley, Minnesota 55432, United States

Immanuel St. Joseph's, Mankato, Minnesota 56002, United States

Minnesota Oncology Hematology, PA - Maplewood, Maplewood, Minnesota 55109, United States

Virginia Piper Cancer Institute at Abbott - Northwestern Hospital, Minneapolis, Minnesota 55407, United States

Hubert H. Humphrey Cancer Center at North Memorial Outpatient Center, Robbinsdale, Minnesota 55422-2900, United States

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

CCOP - Metro-Minnesota, Saint Louis Park, Minnesota 55416, United States

Park Nicollet Cancer Center, Saint Louis Park, Minnesota 55416, United States

United Hospital, Saint Paul, Minnesota 55102, United States

Ridgeview Medical Center, Waconia, Minnesota 55387, United States

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

Minnesota Oncology Hematology, PA - Woodbury, Woodbury, Minnesota 55125, United States

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

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

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

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

St. Vincent Healthcare Cancer Care Services, Billings, Montana 59101, United States

St. James Healthcare Cancer Care, Butte, Montana 59701, United States

Great Falls, Montana 59405, United States

Big Sky Oncology, Great Falls, Montana 59405-5309, United States

Great Falls Clinic - Main Facility, Great Falls, Montana 59405, United States

Sletten Cancer Institute at Benefis Healthcare, Great Falls, Montana 59405, United States

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

Kalispell Medical Oncology at KRMC, Kalispell, Montana 59901, United States

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

Community Medical Center, Missoula, Montana 59801, United States

Guardian Oncology and Center for Wellness, Missoula, Montana 59804, 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

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

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

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

Mid Dakota Clinic, PC, Bismarck, North Dakota 58501, United States

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

CCOP - MeritCare Hospital, Fargo, North Dakota 58122, United States

MeritCare Broadway, Fargo, North Dakota 58122, United States

Altru Cancer Center at Altru Hospital, Grand Forks, North Dakota 58201, United States

Mary Rutan Hospital, Bellefontaine, Ohio 43311, United States

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

Adena Regional Medical Center, Chillicothe, Ohio 45601, United States

North Coast Cancer Care - Clyde, Clyde, Ohio 43410, United States

CCOP - Columbus, Columbus, Ohio 43215, United States

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

Grant Medical Center Cancer Care, Columbus, Ohio 43215, United States

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

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

CCOP - Dayton, Dayton, Ohio 45429, United States

Good Samaritan Hospital, Dayton, Ohio 45406, United States

Grandview Hospital, Dayton, Ohio 45405, United States

Samaritan North Cancer Care Center, Dayton, Ohio 45415, United States

Grady Memorial Hospital, Delaware, Ohio 43015, United States

Hematology Oncology Center, Elyria, Ohio 44035, United States

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

Middletown Regional Hospital, Franklin, Ohio 45005-1066, United States

Charles F. Kettering Memorial Hospital, Kettering, Ohio 45429, United States

Fairfield Medical Center, Lancaster, Ohio 43130, United States

Lima Memorial Hospital, Lima, Ohio 45804, United States

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

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

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

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

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

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

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

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

Mercy Medical Center, Springfield, Ohio 45504, United States

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

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

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

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

St. Anne Mercy Hospital, Toledo, Ohio 43623, United States

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

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

Toledo Hospital, Toledo, Ohio 43606, United States

UVMC Cancer Care Center at Upper Valley Medical Center, Troy, Ohio 45373-1300, United States

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

Mount Carmel St. Ann's Cancer Center, Westerville, Ohio 43081, United States

Clinton Memorial Hospital, Wilmington, Ohio 45177, United States

Ruth G. McMillan Cancer Center at Greene Memorial Hospital, Xenia, Ohio 45385, United States

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

Legacy Mount Hood Medical Center, Gresham, Oregon 97030, United States

Providence Milwaukie Hospital, Milwaukie, Oregon 97222, United States

Adventist Medical Center, Portland, Oregon 97216, United States

CCOP - Columbia River Oncology Program, Portland, Oregon 97225, United States

Legacy Emanuel Hospital and Health Center and Children's Hospital, Portland, Oregon 97227, United States

Legacy Good Samaritan Hospital & Comprehensive Cancer Center, Portland, Oregon 97210, United States

Providence Cancer Center at Providence Portland Medical Center, Portland, Oregon 97213-2967, United States

Providence St. Vincent Medical Center, Portland, Oregon 97225, United States

Legacy Meridian Park Hospital, Tualatin, Oregon 97062, United States

Geisinger Cancer Institute at Geisinger Health, Danville, Pennsylvania 17822-0001, United States

Geisinger Hazleton Cancer Center, Hazleton, Pennsylvania 18201, United States

Guthrie Cancer Center at Guthrie Clinic Sayre, Sayre, Pennsylvania 18840, United States

Geisinger Medical Group - Scenery Park, State College, Pennsylvania 16801, United States

Frank M. and Dorothea Henry Cancer Center at Geisinger Wyoming Valley Medical Center, Wilkes-Barre, Pennsylvania 18711, United States

Mercy Hospital at Wilkes-Barre, Wilkes-Barre, Pennsylvania 18765, United States

AnMed 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

Avera Cancer Institute, Sioux Falls, South Dakota 57105, United States

Medical X-Ray Center, PC, Sioux Falls, South Dakota 57105, United States

Sanford Cancer Center at Sanford USD Medical Center, Sioux Falls, South Dakota 57117-5039, United States

Fredericksburg Oncology, Incorporated, Fredericksburg, Virginia 22401, United States

Southwest Washington Medical Center Cancer Center, Vancouver, Washington 98668, United States

Franciscan Skemp Healthcare - La Crosse Campus, La Crosse, Wisconsin 54601, United States

Additional Information

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

Starting date: February 2008
Last updated: July 3, 2015

Page last updated: August 23, 2015

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