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

• Status: Completed
• Trial end date: 2012-08-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

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

Details

• Lead Sponsor: Alliance for Clinical Trials in Oncology; National Cancer Institute (NCI)
• Collaborator: National Cancer Institute (NCI)
• Treatments: Albumin-Bound Paclitaxel; Carboplatin; Paclitaxel

Criteria

Inclusion Criteria:

• 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)

Exclusion Criteria:

• 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