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Phase III Randomized Study of Alpha-Lipoic Acid in Preventing Platinum-Induced Peripheral Neuropathy in Cancer Patients Receiving a Cisplatin- or Oxaliplatin-Containing Chemotherapy Regimen
Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outcomes
Outline
Trial Contact Information
Related Information
Registry Information
Alternate Title
Alpha-Lipoic Acid in Preventing Peripheral Neuropathy in Patients Receiving Chemotherapy for Cancer
Basic Trial Information
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Protocol IDs
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Phase III
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Supportive care
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Active
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Not specified
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NCI
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MDA-CCC-0327
MDA-2004-0728, MDACCC 03-27, NCT00112996
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Special Category:
NCI Web site featured trial Objectives Primary - Compare whether treatment with alpha-lipoic acid vs placebo decreases the severity and frequency of peripheral neuropathy in cancer patients receiving a cisplatin- or oxaliplatin-containing chemotherapy regimen.
- Compare the protective effect duration of these drugs in these patients.
Secondary - Determine large sensory fiber integrity associated with platinum-induced peripheral neuropathy, as measured by three timed functional tests comprising fastening 6-buttons, walking 50 feet, and placing coins in a cup, in patients treated with these drugs.
- Compare the number of chemotherapy courses and doses received by patients treated with these drugs.
Tertiary - Compare the optimal tumor response (disease progression, stable disease, partial response, or complete response) to chemotherapy in patients treated with these drugs.
Entry Criteria Disease Characteristics:
- Scheduled to receive a cisplatin- or oxaliplatin-containing chemotherapy regimen for cancer
- No established clinical neuropathy
- No clinically evident CNS metastases, including leptomeningeal metastases
Prior/Concurrent Therapy:
Biologic therapy Chemotherapy - See Disease Characteristics
- No carboplatin, vincristine, vinblastine, paclitaxel, or docetaxel for 6 months prior, during, and 6 months after study treatment
Endocrine therapy Radiotherapy Surgery Other - Concurrent medications that can modify peripheral neuropathy (e.g., gabapentin, lamotrigine, carbamazepine, phenytoin, or tricyclic antidepressants) are allowed provided there is no dose adjustment within 2 weeks before study entry and during study participation
- No concurrent vitamin E (including multivitamins that contain vitamin E) ≥ 100 IU per day
- No concurrent physical modality (e.g., annodyne [monochromatic near-infrared photoenergy, 890 nm], microcurrent, or transcutaneous electrical neural stimulation) for peripheral neuropathy related symptoms unless physical or occupational therapy for functional training
Patient Characteristics:
Age Performance status Life expectancy Hematopoietic Hepatic Renal - Creatinine < 2 mg/dL
OR - Creatinine clearance > 45 mL/min
Other - Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception
- Must have a normal state of arousal
- No confusion or memory or concentration deficit
- No history of diabetes mellitus requiring oral medication or insulin treatment
- No chronic alcoholism
- No other active CNS disease (e.g., dementia or encephalopathy)
Expected Enrollment 244A total of 244 patients (122 per treatment arm) will be accrued for this study within 2 years. Outcomes Primary Outcome(s)Severity of neuropathy as measured by the Functional Assessment of Cancer Therapy/Gynecologic Oncology Group-Neurotoxicity Questionnaire total score at baseline and at 6-8, 12, 24, 36, and 48 weeks
Secondary Outcome(s)Group differences in change scores from baseline at 6-8, 12, 24, 36, and 48 weeks
Number of courses received
Optimal tumor response
Outline This is a randomized, double-blind, placebo-controlled, multicenter study. Patients are stratified according to prior platinum-containing treatment (yes vs no). Patients who received prior treatment are further stratified according to prior cumulative platinum exposure (cisplatin < 200 mg/m2 or oxaliplatin < 750 mg/m2 vs cisplatin 200-399 mg/m2 or oxaliplatin 750-999 mg/m2 vs cisplatin >400 mg/m2 or oxaliplatin > 1,000 mg/m2). Patients are randomized to 1 of 2 treatment arms. - Arm I: Patients receive oral alpha-lipoic acid* three times daily for at least 24 weeks in the absence of unacceptable toxicity.
- Arm II: Patients receive oral placebo* three times daily for at least 24 weeks in the absence of unacceptable toxicity.
[Note: *In both arms, patients begin taking study drug 4 days after completion of each chemotherapy treatment and continue taking study drug until 2 days before their next scheduled chemotherapy treatment.] Patients' symptoms of peripheral neuropathy, pain, and functional tests are assessed at baseline and then at weeks 6-8, 12, 24, 36, and 48.
Trial Contact Information
Trial Lead Organizations University of Texas M.D. Anderson CCOP Research Base | | | | Ying Guo, MD, MS, Principal investigator | | | |
Trial Sites
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| U.S.A. |
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| Arkansas |
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Fort Smith |
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| | | | | | | | | Hembree Mercy Cancer Center at St. Edward Mercy Medical Center |
| | | Tony Flippin, MD | | Ph: | 479-484-4700 | | 800-333-1305 |
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| | Email:
tflippin@cooperclinic.com |
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| Indiana |
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Lafayette |
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| | | | Horizon Oncology Center |
| | | Wael Harb, MD | | Ph: | 765-446-5111 | | 866-877-1077 |
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| | Email:
wharb@thecaregroup.com |
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| Kansas |
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Wichita |
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| | | | CCOP - Wichita |
| | | Shaker Dakhil, MD, FACP | | Ph: | 316-268-5784 | | 800-362-5784 |
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| Louisiana |
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Alexandria |
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| | | | Cabrini Center for Cancer Care at Christus St. Frances Cabrini Hospital |
| | | Hafez Al-Halawani, MD | |
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| Michigan |
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Kalamazoo |
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| | | | CCOP - Kalamazoo |
| | | Raymond Lord, MD | |
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rlord@wmcc.org |
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| Minnesota |
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St. Louis Park |
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| | | | CCOP - Metro-Minnesota |
| | | Patrick Flynn, MD | |
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patrick.flynn@usoncology.com |
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| Missouri |
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Springfield |
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| | | | Cancer Research for the Ozarks |
| | | John Goodwin, MD | |
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jgoodwin@sprg.mercy.net |
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| Oregon |
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Portland |
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| | | | CCOP - Columbia River Oncology Program |
| | | Keith Lanier, MD | |
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| Pennsylvania |
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Wynnewood |
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| | | | CCOP - Main Line Health |
| | | Paul Gilman, MD | |
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| South Carolina |
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Greenville |
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| | | | CCOP - Greenville |
| | | Jeffrey Giguere, MD, FACP | |
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| Texas |
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Houston |
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| | | | University of Texas M.D. Anderson CCOP Research Base |
| | | Marlys Harden-Harrison, RN | |
| | | Ying Guo, MD, MS | |
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yguo@mdanderson.org |
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Temple |
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| | | CCOP - Scott and White Hospital |
| | | Lucas Wong, MD | |
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lwong@swmail.sw.org |
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| Wisconsin |
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Marshfield |
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| | | | Marshfield Clinic - Marshfield Center |
| | | Tarit Banerjee, MD, FACP | |
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Related Information Featured trial article
| Registry Information | | | Official Title | | Prevention of Cisplatin- or Oxaliplatin-Induced Peripheral Neuropathy with Alpha-Lipoic Acid: A Placebo-Controlled Phase III Trial | | | Trial Start Date | | 2007-01-03 | | | Registered in ClinicalTrials.gov | | NCT00112996 | | | Date Submitted to PDQ | | 2004-10-27 | | | Information Last Verified | | 2007-10-15 | | | NCI Grant/Contract Number | | CA16672 |
Note: The purpose of most clinical trials listed in this database is to test new cancer treatments, or new methods of diagnosing, screening, or preventing cancer. Because all potentially harmful side effects are not known before a trial is conducted, dose and schedule modifications may be required for participants if they develop side effects from the treatment or test. The therapy or test described in this clinical trial is intended for use by clinical oncologists in carefully structured settings, and may not prove to be more effective than standard treatment. A responsible investigator associated with this clinical trial should be consulted before using this protocol. |
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