Baclofen-Amitriptyline Hydrochloride-Ketamine Gel in Treating Peripheral Neuropathy Caused by Chemotherapy in Patients With Cancer

• Status: Completed
• Trial end date: 2010-01-01
• Target enrollment: 0
• Participant gender: All

Summary

RATIONALE: Baclofen-amitriptyline-ketamine (BAK) gel may lessen peripheral neuropathy caused by chemotherapy. It is not yet known whether BAK gel is more effective than a placebo in treating peripheral neuropathy caused by chemotherapy .

PURPOSE: This randomized phase III trial is studying BAK gel to see how well it works compared with a placebo in treating peripheral neuropathy caused by chemotherapy in patients with cancer.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Alliance for Clinical Trials in Oncology
• Collaborator: National Cancer Institute (NCI)
• Treatments: Amitriptyline; Amitriptyline, perphenazine drug combination; Baclofen; Ketamine

Criteria

DISEASE CHARACTERISTICS:>

• Diagnosis of cancer>

• Received or currently receiving neurotoxic chemotherapy including, but not limited to, taxanes (e.g., paclitaxel or docetaxel); platinum-based compounds (e.g., carboplatin, cisplatin, or oxaliplatin); vinca alkaloids (e.g., vincristine or vinblastine); or other neurotoxic chemotherapy agents (e.g., bortezomib, lenalidomide, or thalidomide)>

• Must have pain or symptoms of peripheral neuropathy attributable to chemotherapy for ≥ 1 month>

• Neuropathy is limited to either hands and/or feet where gel can be applied>

• Neuropathic pain score of ≥ 4 out of 10 on the numbness/tingling/pain numeric analogue scale>

• No pre-existing or history of peripheral neuropathy due to any cause other than chemotherapy (e.g., diabetes, alcohol, toxin, heredity)> PATIENT CHARACTERISTICS:>

• ECOG performance status 0-2>

• Life expectancy ≥ 4 months>

• Creatinine ≤ 1.5 times upper limit of normal>

• Not pregnant or nursing>

• No ability to bear children defined by 1 of the criteria:>

• Menopausal (12 months and no menstrual period if natural menopause)>

• Underwent a hysterectomy and/or oophorectomy>

• Permanent surgical sterilization (tubal ligation)>

• Fertile patients must use effective contraception>

• Able to complete questionnaires independently or with assistance>

• Able to sign informed consent and understand the nature of a placebo-controlled trial>

• No history of an allergic reaction to baclofen, amitriptyline hydrochloride, and/or ketamine>

• No diagnosis of any New York Heart Association class I-IV congestive heart failure>

• No diagnosis of coronary artery disease including, but not limited to, myocardial infarction, within the past 5 years>

• No other medical condition that, in the opinion of the treating physician or allied health professional, would make this clinical trial unreasonably hazardous for the patient>

• No skin abnormalities at the intended application sites (hands and feet) of study gel (i.e., skin breakdown)> PRIOR CONCURRENT THERAPY:>

• See Disease Characteristics>

• More than 30 days since prior anticonvulsants, tricyclic antidepressants, monoamine oxidase inhibitor, or other neuropathic pain medication (e.g., carbamazepine, phenytoin, valproic acid, gabapentin, lamotrigine, topical lidocaine patch or gel, capsaicin cream, or amifostine)>

• Patients treated with any of these agents for peripheral neuropathy for ≤ 1 week during the past 30 days are eligible provided they are no longer taking the agent>

• More than 5 years since prior percutaneous transluminal coronary angioplasty or coronary artery bypass graft>

• Prior heart valve replacement surgery allowed provided patient has fully recovered from the surgery>

• No concurrent use of study agents other than as specified in the trial>