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Gabapentin in Treating Peripheral Neuropathy in Cancer Patients Undergoing Chemotherapy

Primary Purpose

Neurotoxicity, Pain

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
gabapentin
placebo
Sponsored by
Alliance for Clinical Trials in Oncology
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Neurotoxicity focused on measuring neurotoxicity, pain

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

DISEASE CHARACTERISTICS: Has received or is currently receiving neurotoxic chemotherapy, including taxanes (e.g., paclitaxel or docetaxel), platinum-based compounds (e.g., carboplatin, cisplatin, or oxaliplatin), or vinca alkaloids (e.g., vincristine or vinblastine) Pain or symptoms of peripheral neuropathy of at least 1 month duration attributed to chemotherapy-induced peripheral neuropathy Average daily pain rating of at least 4 out of 10 using the pain numerical rating scale (where 0 is no pain and 10 is the worst pain possible) OR Evidence of peripheral neuropathy of at least grade 1 out of 3 by ECOG Common Toxicity Criteria for sensory neuropathy No other identified causes of painful paresthesia existing prior to chemotherapy No radiotherapy-induced or malignant plexopathy No lumbar or cervical radiculopathy No pre-existing peripheral neuropathy of another etiology, including: B12 deficiency AIDS Monoclonal gammopathy Diabetes Heavy metal poisoning Amyloidosis Syphilis Hyperthyroidism or hypothyroidism Inherited neuropathy PATIENT CHARACTERISTICS: Age: 18 and over Life expectancy: At least 6 months Renal: Creatinine no greater than 1.5 times upper limit of normal Other: No prior allergic reaction or intolerance to gabapentin No significant psychiatric illness (e.g., mania, psychosis, or schizophrenia) that would preclude study compliance No extreme difficulty swallowing pills Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception Other: More than 30 days since prior investigational agent for pain control Concurrent selective serotonin reuptake inhibitors allowed Concurrent nonsteroidal anti-inflammatory drugs allowed No concurrent tricyclic antidepressant (e.g., amitriptyline, nortriptyline, or desipramine)* No concurrent monoamine oxidase inhibitor* No concurrent opioid analgesic* No other concurrent adjuvant analgesic (e.g., anticonvulsant, clonazepam, or mexiletine)* No concurrent topical analgesics (e.g., lidocaine gel or lidocaine patch)* No concurrent amifostine No concurrent investigational agent for pain control NOTE: * For pain or symptoms due to chemotherapy-induced peripheral neuropathy

Sites / Locations

  • CCOP - Mayo Clinic Scottsdale Oncology Program
  • Mayo Clinic
  • CCOP - Illinois Oncology Research Association
  • CCOP - Carle Cancer Center
  • CCOP - Cedar Rapids Oncology Project
  • CCOP - Iowa Oncology Research Association
  • Siouxland Hematology-Oncology
  • CCOP - Wichita
  • CCOP - Ochsner
  • CCOP - Michigan Cancer Research Consortium
  • CCOP - Duluth
  • Mayo Clinic Cancer Center
  • CentraCare Health Plaza
  • CCOP - Missouri Valley Cancer Consortium
  • Medcenter One Health System
  • Altru Cancer Center
  • CCOP - Toledo Community Hospital
  • CCOP - Oklahoma
  • CCOP - Upstate Carolina
  • Rapid City Regional Hospital
  • CCOP - Sioux Community Cancer Consortium
  • CCOP - St. Vincent Hospital Cancer Center, Green Bay
  • Allan Blair Cancer Centre

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

gabapentin

placebo

Arm Description

Patients receive titrating doses of oral gabapentin twice daily and then three times daily for 3 weeks. Patients then receive a fixed dose of oral gabapentin three times daily for 3 weeks. Patients cross-over to therapy as in arm II at week 8. Quality of life is assessed at baseline and then at the end of weeks 6, 8, and 14.

Patients receive titrating doses of oral placebo and then a fixed dose of oral placebo as in arm I. Patients cross-over to therapy as in arm I at week 8. Quality of life is assessed at baseline and then at the end of weeks 6, 8, and 14.

Outcomes

Primary Outcome Measures

Change in pain and symptoms

Secondary Outcome Measures

Quality of life

Full Information

First Posted
December 7, 2001
Last Updated
July 1, 2016
Sponsor
Alliance for Clinical Trials in Oncology
Collaborators
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT00027963
Brief Title
Gabapentin in Treating Peripheral Neuropathy in Cancer Patients Undergoing Chemotherapy
Official Title
The Efficacy Of Gabapentin In The Management Of Chemotherapy-Induced Peripheral Neuropathy: A Phase III Randomized, Double-Blind, Placebo-Controlled, Crossover Trial
Study Type
Interventional

2. Study Status

Record Verification Date
July 2016
Overall Recruitment Status
Completed
Study Start Date
February 2002 (undefined)
Primary Completion Date
November 2007 (Actual)
Study Completion Date
November 2007 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Alliance for Clinical Trials in Oncology
Collaborators
National Cancer Institute (NCI)

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
RATIONALE: Gabapentin may be effective in relieving pain and other symptoms of peripheral neuropathy. It is not yet known if gabapentin is effective in treating peripheral neuropathy in cancer patients undergoing chemotherapy. PURPOSE: Randomized phase III trial to determine the effectiveness of gabapentin in treating pain and other symptoms of peripheral neuropathy in cancer patients undergoing chemotherapy.
Detailed Description
OBJECTIVES: Determine whether gabapentin improves the pain and other symptoms in cancer patients with chemotherapy-induced peripheral neuropathy. Determine the effect of this drug on symptom distress, mood states, functional abilities, and overall quality of life in these patients. Determine the toxic effects of this drug in these patients. OUTLINE: This is a randomized, double-blind, placebo-controlled, multicenter study. Patients are stratified according to neurotoxic chemotherapy (active vs nonactive and discontinued vs completed) and neurotoxic chemotherapeutic agents (vinca alkaloids vs taxanes vs platinum-based compounds vs combination of two or more of the above agents). Patients are randomized to 1 of 2 treatment arms. Arm I: Patients receive titrating doses of oral gabapentin twice daily and then three times daily for 3 weeks. Patients then receive a fixed dose of oral gabapentin three times daily for 3 weeks. Patients cross-over to therapy as in arm II at week 8. Arm II: Patients receive titrating doses of oral placebo and then a fixed dose of oral placebo as in arm I. Patients cross-over to therapy as in arm I at week 8. Quality of life is assessed at baseline and then at the end of weeks 6, 8, and 14. PROJECTED ACCRUAL: A total of 100 patients (50 per treatment arm) will be accrued for this study.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Neurotoxicity, Pain
Keywords
neurotoxicity, pain

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Phase 3
Interventional Study Model
Crossover Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
100 (Actual)

8. Arms, Groups, and Interventions

Arm Title
gabapentin
Arm Type
Experimental
Arm Description
Patients receive titrating doses of oral gabapentin twice daily and then three times daily for 3 weeks. Patients then receive a fixed dose of oral gabapentin three times daily for 3 weeks. Patients cross-over to therapy as in arm II at week 8. Quality of life is assessed at baseline and then at the end of weeks 6, 8, and 14.
Arm Title
placebo
Arm Type
Placebo Comparator
Arm Description
Patients receive titrating doses of oral placebo and then a fixed dose of oral placebo as in arm I. Patients cross-over to therapy as in arm I at week 8. Quality of life is assessed at baseline and then at the end of weeks 6, 8, and 14.
Intervention Type
Drug
Intervention Name(s)
gabapentin
Intervention Type
Other
Intervention Name(s)
placebo
Primary Outcome Measure Information:
Title
Change in pain and symptoms
Time Frame
Up to 14 weeks
Secondary Outcome Measure Information:
Title
Quality of life
Time Frame
Up to 14 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
DISEASE CHARACTERISTICS: Has received or is currently receiving neurotoxic chemotherapy, including taxanes (e.g., paclitaxel or docetaxel), platinum-based compounds (e.g., carboplatin, cisplatin, or oxaliplatin), or vinca alkaloids (e.g., vincristine or vinblastine) Pain or symptoms of peripheral neuropathy of at least 1 month duration attributed to chemotherapy-induced peripheral neuropathy Average daily pain rating of at least 4 out of 10 using the pain numerical rating scale (where 0 is no pain and 10 is the worst pain possible) OR Evidence of peripheral neuropathy of at least grade 1 out of 3 by ECOG Common Toxicity Criteria for sensory neuropathy No other identified causes of painful paresthesia existing prior to chemotherapy No radiotherapy-induced or malignant plexopathy No lumbar or cervical radiculopathy No pre-existing peripheral neuropathy of another etiology, including: B12 deficiency AIDS Monoclonal gammopathy Diabetes Heavy metal poisoning Amyloidosis Syphilis Hyperthyroidism or hypothyroidism Inherited neuropathy PATIENT CHARACTERISTICS: Age: 18 and over Life expectancy: At least 6 months Renal: Creatinine no greater than 1.5 times upper limit of normal Other: No prior allergic reaction or intolerance to gabapentin No significant psychiatric illness (e.g., mania, psychosis, or schizophrenia) that would preclude study compliance No extreme difficulty swallowing pills Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception Other: More than 30 days since prior investigational agent for pain control Concurrent selective serotonin reuptake inhibitors allowed Concurrent nonsteroidal anti-inflammatory drugs allowed No concurrent tricyclic antidepressant (e.g., amitriptyline, nortriptyline, or desipramine)* No concurrent monoamine oxidase inhibitor* No concurrent opioid analgesic* No other concurrent adjuvant analgesic (e.g., anticonvulsant, clonazepam, or mexiletine)* No concurrent topical analgesics (e.g., lidocaine gel or lidocaine patch)* No concurrent amifostine No concurrent investigational agent for pain control NOTE: * For pain or symptoms due to chemotherapy-induced peripheral neuropathy
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Charles L. Loprinzi, MD
Organizational Affiliation
Mayo Clinic
Official's Role
Study Chair
Facility Information:
Facility Name
CCOP - Mayo Clinic Scottsdale Oncology Program
City
Scottsdale
State/Province
Arizona
ZIP/Postal Code
85259-5404
Country
United States
Facility Name
Mayo Clinic
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32224
Country
United States
Facility Name
CCOP - Illinois Oncology Research Association
City
Peoria
State/Province
Illinois
ZIP/Postal Code
61602
Country
United States
Facility Name
CCOP - Carle Cancer Center
City
Urbana
State/Province
Illinois
ZIP/Postal Code
61801
Country
United States
Facility Name
CCOP - Cedar Rapids Oncology Project
City
Cedar Rapids
State/Province
Iowa
ZIP/Postal Code
52403-1206
Country
United States
Facility Name
CCOP - Iowa Oncology Research Association
City
Des Moines
State/Province
Iowa
ZIP/Postal Code
50309-1016
Country
United States
Facility Name
Siouxland Hematology-Oncology
City
Sioux City
State/Province
Iowa
ZIP/Postal Code
51101-1733
Country
United States
Facility Name
CCOP - Wichita
City
Wichita
State/Province
Kansas
ZIP/Postal Code
67214-3882
Country
United States
Facility Name
CCOP - Ochsner
City
New Orleans
State/Province
Louisiana
ZIP/Postal Code
70121
Country
United States
Facility Name
CCOP - Michigan Cancer Research Consortium
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48106
Country
United States
Facility Name
CCOP - Duluth
City
Duluth
State/Province
Minnesota
ZIP/Postal Code
55805
Country
United States
Facility Name
Mayo Clinic Cancer Center
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States
Facility Name
CentraCare Health Plaza
City
Saint Cloud
State/Province
Minnesota
ZIP/Postal Code
56303
Country
United States
Facility Name
CCOP - Missouri Valley Cancer Consortium
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68106
Country
United States
Facility Name
Medcenter One Health System
City
Bismarck
State/Province
North Dakota
ZIP/Postal Code
58501-5505
Country
United States
Facility Name
Altru Cancer Center
City
Grand Forks
State/Province
North Dakota
ZIP/Postal Code
58201
Country
United States
Facility Name
CCOP - Toledo Community Hospital
City
Toledo
State/Province
Ohio
ZIP/Postal Code
43623-3456
Country
United States
Facility Name
CCOP - Oklahoma
City
Tulsa
State/Province
Oklahoma
ZIP/Postal Code
74136
Country
United States
Facility Name
CCOP - Upstate Carolina
City
Spartanburg
State/Province
South Carolina
ZIP/Postal Code
29303
Country
United States
Facility Name
Rapid City Regional Hospital
City
Rapid City
State/Province
South Dakota
ZIP/Postal Code
57709
Country
United States
Facility Name
CCOP - Sioux Community Cancer Consortium
City
Sioux Falls
State/Province
South Dakota
ZIP/Postal Code
57104
Country
United States
Facility Name
CCOP - St. Vincent Hospital Cancer Center, Green Bay
City
Green Bay
State/Province
Wisconsin
ZIP/Postal Code
54301
Country
United States
Facility Name
Allan Blair Cancer Centre
City
Regina
State/Province
Saskatchewan
ZIP/Postal Code
S4T 7T1
Country
Canada

12. IPD Sharing Statement

Citations:
PubMed Identifier
17853395
Citation
Rao RD, Michalak JC, Sloan JA, Loprinzi CL, Soori GS, Nikcevich DA, Warner DO, Novotny P, Kutteh LA, Wong GY; North Central Cancer Treatment Group. Efficacy of gabapentin in the management of chemotherapy-induced peripheral neuropathy: a phase 3 randomized, double-blind, placebo-controlled, crossover trial (N00C3). Cancer. 2007 Nov 1;110(9):2110-8. doi: 10.1002/cncr.23008.
Results Reference
result

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Gabapentin in Treating Peripheral Neuropathy in Cancer Patients Undergoing Chemotherapy

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