Gabapentin in Treating Peripheral Neuropathy in Cancer Patients Undergoing Chemotherapy
Overview[ - collapse ][ - ]
| Purpose | 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. |
|---|---|
| Condition | Neurotoxicity Pain |
| Intervention | Drug: gabapentin Procedure: quality-of-life assessment |
| Phase | Phase 3 |
| Sponsor | North Central Cancer Treatment Group |
| Responsible Party | National Cancer Institute (NCI) |
| ClinicalTrials.gov Identifier | NCT00027963 |
| First Received | December 7, 2001 |
| Last Updated | August 19, 2009 |
| Last verified | April 2004 |
Tracking Information[ + expand ][ + ]
| First Received Date | December 7, 2001 |
|---|---|
| Last Updated Date | August 19, 2009 |
| Start Date | February 2002 |
| Estimated Primary Completion Date | Not Provided |
| Current Primary Outcome Measures | Not Provided |
| Current Secondary Outcome Measures | Not Provided |
Descriptive Information[ + expand ][ + ]
| 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 |
| 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. |
| Study Type | Interventional |
| Study Phase | Phase 3 |
| Study Design | Allocation: Randomized, Masking: Double-Blind, Primary Purpose: Supportive Care |
| Condition |
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| Intervention | Drug: gabapentin Procedure: quality-of-life assessment |
| Study Arm (s) | Not Provided |
Recruitment Information[ + expand ][ + ]
| Recruitment Status | Completed |
|---|---|
| Estimated Enrollment | Not Provided |
| Estimated Completion Date | Not Provided |
| Estimated Primary Completion Date | November 2007 |
| 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 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 |
| Gender | Both |
| Ages | 18 Years |
| Accepts Healthy Volunteers | No |
| Contacts | Not Provided |
| Location Countries | United States, Canada |
Administrative Information[ + expand ][ + ]
| NCT Number | NCT00027963 |
|---|---|
| Other Study ID Numbers | CDR0000069098 |
| Has Data Monitoring Committee | Not Provided |
| Information Provided By | National Cancer Institute (NCI) |
| Study Sponsor | North Central Cancer Treatment Group |
| Collaborators | National Cancer Institute (NCI) |
| Investigators | Study Chair: Charles L. Loprinzi, MD Mayo Clinic |
| Verification Date | April 2004 |
Locations[ + expand ][ + ]
| CCOP - Mayo Clinic Scottsdale Oncology Program | Scottsdale, Arizona, United States, 85259-5404 |
|---|---|
| Mayo Clinic | Jacksonville, Florida, United States, 32224 |
| CCOP - Illinois Oncology Research Association | Peoria, Illinois, United States, 61602 |
| CCOP - Carle Cancer Center | Urbana, Illinois, United States, 61801 |
| CCOP - Cedar Rapids Oncology Project | Cedar Rapids, Iowa, United States, 52403-1206 |
| CCOP - Iowa Oncology Research Association | Des Moines, Iowa, United States, 50309-1016 |
| Siouxland Hematology-Oncology | Sioux City, Iowa, United States, 51101-1733 |
| CCOP - Wichita | Wichita, Kansas, United States, 67214-3882 |
| CCOP - Ochsner | New Orleans, Louisiana, United States, 70121 |
| CCOP - Michigan Cancer Research Consortium | Ann Arbor, Michigan, United States, 48106 |
| CCOP - Duluth | Duluth, Minnesota, United States, 55805 |
| Mayo Clinic Cancer Center | Rochester, Minnesota, United States, 55905 |
| CentraCare Health Plaza | Saint Cloud, Minnesota, United States, 56303 |
| CCOP - Missouri Valley Cancer Consortium | Omaha, Nebraska, United States, 68106 |
| Medcenter One Health System | Bismarck, North Dakota, United States, 58501-5505 |
| Altru Cancer Center | Grand Forks, North Dakota, United States, 58201 |
| CCOP - Toledo Community Hospital | Toledo, Ohio, United States, 43623-3456 |
| CCOP - Oklahoma | Tulsa, Oklahoma, United States, 74136 |
| CCOP - Upstate Carolina | Spartanburg, South Carolina, United States, 29303 |
| Rapid City Regional Hospital | Rapid City, South Dakota, United States, 57709 |
| CCOP - Sioux Community Cancer Consortium | Sioux Falls, South Dakota, United States, 57104 |
| CCOP - St. Vincent Hospital Cancer Center, Green Bay | Green Bay, Wisconsin, United States, 54301 |
| Allan Blair Cancer Centre | Regina, Saskatchewan, Canada, S4T 7T1 |