Gabapentin in Treating Peripheral Neuropathy in Cancer Patients Undergoing Chemotherapy

NCT00027963 | Completed Phase 3

• 4 other identifiers: NCCTG-N00C3CDR0000069098NCCTG-CCC-0020NCI-P01-0196
• Study Type: interventional
• Target: 100
• Locations: 2 countries
• Sites: 23

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.

Conditions

Neurotoxicity; Pain

Keywords

neurotoxicity; pain

Outcome Measures

Primary Outcomes (1)

• Change in pain and symptoms

  Up to 14 weeks

Secondary Outcomes (1)

• Quality of life

  Up to 14 weeks

Study Arms (2)

gabapentin

EXPERIMENTAL

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.

Drug: gabapentin

placebo

PLACEBO COMPARATOR

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.

Other: placebo

Interventions

gabapentin DRUG

gabapentin

placebo OTHER

placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Alliance for Clinical Trials in Oncology: lead
• National Cancer Institute (NCI): collaborator

Study Sites (23)

CCOP - Mayo Clinic Scottsdale Oncology Program

Scottsdale, Arizona, 85259-5404, United States

Location

Mayo Clinic

Jacksonville, Florida, 32224, United States

Location

CCOP - Illinois Oncology Research Association

Peoria, Illinois, 61602, United States

Location

CCOP - Carle Cancer Center

Urbana, Illinois, 61801, United States

Location

CCOP - Cedar Rapids Oncology Project

Cedar Rapids, Iowa, 52403-1206, United States

Location

CCOP - Iowa Oncology Research Association

Des Moines, Iowa, 50309-1016, United States

Location

Siouxland Hematology-Oncology

Sioux City, Iowa, 51101-1733, United States

Location

CCOP - Wichita

Wichita, Kansas, 67214-3882, United States

Location

CCOP - Ochsner

New Orleans, Louisiana, 70121, United States

Location

CCOP - Michigan Cancer Research Consortium

Ann Arbor, Michigan, 48106, United States

Location

CCOP - Duluth

Duluth, Minnesota, 55805, United States

Location

Mayo Clinic Cancer Center

Rochester, Minnesota, 55905, United States

Location

CentraCare Health Plaza

Saint Cloud, Minnesota, 56303, United States

Location

CCOP - Missouri Valley Cancer Consortium

Omaha, Nebraska, 68106, United States

Location

Medcenter One Health System

Bismarck, North Dakota, 58501-5505, United States

Location

Altru Cancer Center

Grand Forks, North Dakota, 58201, United States

Location

CCOP - Toledo Community Hospital

Toledo, Ohio, 43623-3456, United States

Location

CCOP - Oklahoma

Tulsa, Oklahoma, 74136, United States

Location

CCOP - Upstate Carolina

Spartanburg, South Carolina, 29303, United States

Location

Rapid City Regional Hospital

Rapid City, South Dakota, 57709, United States

Location

CCOP - Sioux Community Cancer Consortium

Sioux Falls, South Dakota, 57104, United States

Location

CCOP - St. Vincent Hospital Cancer Center, Green Bay

Green Bay, Wisconsin, 54301, United States

Location

Allan Blair Cancer Centre

Regina, Saskatchewan, S4T 7T1, Canada

Location

Related Publications (1)

• 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.

  PMID: 17853395 RESULT

MeSH Terms

Conditions

Neurotoxicity Syndromes; Pain

Interventions

Gabapentin

Condition Hierarchy (Ancestors)

Nervous System Diseases; Poisoning; Chemically-Induced Disorders; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Amines; Organic Chemicals; gamma-Aminobutyric Acid; Aminobutyrates; Butyrates; Acids, Acyclic; Carboxylic Acids; Cyclohexanecarboxylic Acids; Acids, Carbocyclic; Cyclohexanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Amino Acids; Amino Acids, Peptides, and Proteins

Study Officials

• Charles L. Loprinzi, MD

  Mayo Clinic

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 7, 2001
• First Posted: January 27, 2003
• Study Start: February 1, 2002
• Primary Completion: November 1, 2007
• Study Completion: November 1, 2007
• Last Updated: July 4, 2016

Record last verified: 2016-07

Locations

CA (1); US (22)