Glutathione in Preventing Peripheral Neuropathy Caused by Paclitaxel and Carboplatin in Patients With Ovarian Cancer, Fallopian Tube Cancer, and/or Primary Peritoneal Cancer
Condition: 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
MeSH terms: Ovarian Neoplasms; Carcinoma, Ovarian Epithelial; Fallopian Tube Neoplasms; Peritoneal Neoplasms; Peripheral Nervous System Diseases; Neurotoxicity Syndromes
Intervention: Carboplatin; Glutathione; Laboratory Biomarker Analysis; Paclitaxel; Placebo; Quality-of-Life Assessment
Intervention description: Given IV, over 30 minutes per planned chemotherapy regimen; Given IV, over 15 minutes, immediately before chemotherapy administration; Correlative studies; Given IV, over 1 or 3 hours, per planned chemotherapy regimen; Given IV; Ancillary studies
Intervention MeSH terms: Paclitaxel; Carboplatin; Albumin-Bound Paclitaxel
Phase: Phase 3
Study type: Interventional
Primary purpose: Supportive Care
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 195.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

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.
    

Eligibility 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