Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outline
Published Results
Trial Contact Information
Registry Information

Alternate Title

Gabapentin in Treating Peripheral Neuropathy in Cancer Patients Undergoing Chemotherapy

Basic Trial Information

Phase	Type	Status	Age	Sponsor	Protocol IDs
Phase III	Supportive care	Completed	18 and over	NCI	NCCTG-N00C3 NCCTG-CCC-0020, NCI-P01-0196, NCT00027963

Objectives

1. Determine whether gabapentin improves the pain and other symptoms in cancer patients with chemotherapy-induced peripheral neuropathy.
2. Determine the effect of this drug on symptom distress, mood states, functional abilities, and overall quality of life in these patients.
3. Determine the toxic effects of this drug in these patients.

Entry 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

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]

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

Expected Enrollment

A total of 100 patients (50 per treatment arm) will be accrued for this study.

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.

Rao RD, Michalak JC, Sloan JA, et al.: Efficacy of gabapentin in the management of chemotherapy-induced peripheral neuropathy: a phase 3 randomized, double-blind, placebo-controlled, crossover trial (N00C3). Cancer 110 (9): 2110-8, 2007.[PUBMED Abstract]

Trial Contact Information

Trial Lead Organizations

North Central Cancer Treatment Group

Charles Loprinzi, MD, Protocol chair		Ph: 507-284-8964 Email: cloprinzi@mayo.edu

Registry Information
Official Title		The Efficacy Of Gabapentin In The Management Of Chemotherapy-Induced Peripheral Neuropathy: A Phase III Randomized, Double-Blind, Placebo-Controlled, Crossover Trial
Trial Start Date		2002-02-08
Trial Completion Date		2007-11-01
Registered in ClinicalTrials.gov		NCT00027963
Date Submitted to PDQ		2001-10-25
Information Last Verified		2004-04-26
NCI Grant/Contract Number		CA31946

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