Gabapentin in Treating Peripheral Neuropathy in Cancer Patients Undergoing Chemotherapy

This study has been completed.
Sponsor:
Collaborator:
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00027963
First received: December 7, 2001
Last updated: August 19, 2009
Last verified: April 2004

December 7, 2001
August 19, 2009
February 2002
November 2007   (final data collection date for primary outcome measure)
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Not Provided
Complete list of historical versions of study NCT00027963 on ClinicalTrials.gov Archive Site
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Gabapentin in Treating Peripheral Neuropathy in Cancer Patients Undergoing Chemotherapy
The Efficacy Of Gabapentin In The Management Of Chemotherapy-Induced Peripheral Neuropathy: A Phase III Randomized, Double-Blind, Placebo-Controlled, Crossover Trial

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.

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.

Interventional
Phase 3
Allocation: Randomized
Masking: Double-Blind
Primary Purpose: Supportive Care
  • Neurotoxicity
  • Pain
  • Drug: gabapentin
  • Procedure: quality-of-life assessment
Not Provided
Rao RD, Michalak JC, Sloan JA, Loprinzi CL, Soori GS, Nikcevich DA, Warner DO, Novotny P, Kutteh LA, Wong GY; and the 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 Sep 12; [Epub ahead of print]

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
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Not Provided
November 2007   (final data collection date for primary outcome measure)

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

Performance status:

  • Not specified

Life expectancy:

  • At least 6 months

Hematopoietic:

  • Not specified

Hepatic:

  • Not specified

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

PRIOR CONCURRENT THERAPY:

Biologic therapy:

  • Not specified

Chemotherapy:

  • See Disease Characteristics

Endocrine therapy:

  • Not specified

Radiotherapy:

  • See Disease Characteristics

Surgery:

  • Not specified

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Canada,   United States
 
NCT00027963
CDR0000069098, NCCTG-N00C3, NCCTG-CCC-0020, NCI-P01-0196
Not Provided
Not Provided
North Central Cancer Treatment Group
National Cancer Institute (NCI)
Study Chair: Charles L. Loprinzi, MD Mayo Clinic
National Cancer Institute (NCI)
April 2004

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP