Glutathione in Preventing Peripheral Neuropathy Caused by Paclitaxel and Carboplatin in Patients With Ovarian Cancer, Fallopian Tube Cancer, and/or Primary Peritoneal Cancer

Completed · Phase 3 · Has a placebo group

Conditions studied: Chemotherapeutic Agent Toxicity, Neuropathy, Neurotoxicity Syndrome, Pain, Stage IIIA Fallopian Tube Cancer, Stage IIIA Ovarian Cancer, Stage IIIA Primary Peritoneal Cancer, Stage IIIB Fallopian Tube Cancer, Stage IIIB Ovarian Cancer, Stage IIIB Primary Peritoneal Cancer, Stage IIIC Fallopian Tube Cancer, Stage IIIC Ovarian Cancer, Stage IIIC Primary Peritoneal Cancer, Stage IV Fallopian Tube Cancer, Stage IV Ovarian Cancer, Stage IV Primary Peritoneal Cancer

In brief

This randomized phase III trial is studying glutathione to see how well it works in preventing peripheral neuropathy caused by paclitaxel and carboplatin in patients with ovarian cancer, fallopian tube cancer, and/or primary peritoneal cancer. Drugs used in chemotherapy work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Chemoprotective drugs, such as glutathione, may help prevent peripheral neuropathy caused by paclitaxel and carboplatin. It is not yet known whether glutathione is more effective than a placebo in preventing peripheral neuropathy.

Key facts

Study ID

NCT02311907

Run by

Alliance for Clinical Trials in Oncology

People needed

195

Starts

2009-12-01

Expected to finish

2012-08-01

Last updated by the study team

2017-02-23

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Scheduled to undergo treatment with TAXOL at 150-200 mg/m2 and CBDCA at area under the curve (AUC) = 5-7 every 21 or 28 days for at least 12 weeks; alternatively, paclitaxel can be prescribed at 80 mg/m2 weekly for at least 12 weeks, with the same CBDCA dose of AUC = 5-7 every 21 days; additional chemotherapy agents are allowed (bevacizumab, etoposide, etc) per physician discretion, as long as they are not known to be neurotoxic; Note: patients ideally will begin GSH therapy prior to their first dose of this chemotherapy, but must begin GSH therapy prior to their second dose of chemotherapy
• Ability to sign informed consent and understand the nature of a placebo-controlled trial
• Eastern Cooperative Oncology Group (ECOG) performance status 0-2
• Ability to complete English language questionnaire(s) by themselves or with assistance
• Life expectancy >= 6 months
• Negative pregnancy test done =< 7 days prior to registration, for women of childbearing potential only, per clinician discretion
• Willingness to provide blood specimens as required by the protocol
• White blood cell (WBC) >= 3400
• Absolute neutrophil count (ANC) >= 1500
• Platelet (PLT) >= 100,000
• Hemoglobin (HgB) > 10.0
• Creatinine =< 1.5 x upper limit of normal (ULN)

You may not qualify if…

• Pre-existing history of peripheral neuropathy > grade 1 (National Cancer Institute [NCI] CTCAE version [v] 4.0) due to any cause (e.g., chemotherapy, diabetes, alcohol, toxin, or heredity)
• Other medical conditions, which in the opinion of the treating physician/allied health professional would make this protocol unreasonably hazardous for the patient
• Any of the following:
• Pregnant women
• Nursing women
• Women of childbearing potential who are unwilling to employ adequate contraception
• Prior TAXOL and/or CBDCA chemotherapy treatment (other than the current treatment regimen)
• Concurrent use of any agent being used specifically to prevent or treat neuropathy, including but not limited to the following:
• Gabapentin
• Glutamine powder or glutamine tablets
• Vitamin B6 or E

Where it is running

• Fairbanks Memorial Hospital — Fairbanks, Alaska, United States
• Mayo Clinic in Arizona — Scottsdale, Arizona, United States
• Northbay Cancer Center — Fairfield, California, United States
• Cancer Care Associates of Fresno Medical Group Inc — Fresno, California, United States
• Saint Joseph Hospital - Orange — Orange, California, United States
• UC Irvine Health/Chao Family Comprehensive Cancer Center — Orange, California, United States
• Feather River Cancer Center — Paradise, California, United States
• Sutter Roseville Medical Center — Roseville, California, United States
• Sutter General Hospital — Sacramento, California, United States
• The Medical Center of Aurora — Aurora, Colorado, United States
• Boulder Community Hospital — Boulder, Colorado, United States
• Penrose-Saint Francis Healthcare — Colorado Springs, Colorado, United States
• Porter Adventist Hospital — Denver, Colorado, United States
• Exempla Saint Joseph Hospital — Denver, Colorado, United States
• Presbyterian - Saint Lukes Medical Center - Health One — Denver, Colorado, United States
• Rose Medical Center — Denver, Colorado, United States
• Colorado Cancer Research Program CCOP — Denver, Colorado, United States
• Swedish Medical Center — Englewood, Colorado, United States
• Poudre Valley Hospital — Fort Collins, Colorado, United States
• Front Range Cancer Specialists — Fort Collins, Colorado, United States
• Saint Mary's Hospital and Regional Medical Center — Grand Junction, Colorado, United States
• North Colorado Medical Center — Greeley, Colorado, United States
• Saint Anthony Hospital — Lakewood, Colorado, United States
• Sky Ridge Medical Center — Lone Tree, Colorado, United States
• Providence Hospital — Mobile, Alabama, United States

Full record on ClinicalTrials.gov

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